Annuncio • Jul 06
Vicore Pharma Holding AB Announces Appointment of Rob Slack as Chief Scientific Officer Vicore Pharma Holding AB announced the appointment of Rob Slack, PhD, FRSB, as Chief Scientific Officer. Dr. Slack succeeded Johan Raud, MD, PhD, who, after a long and distinguished career in drug discovery and a defining contribution to Vicore's science, transitioned to Senior Advisor, supporting the company through key upcoming milestones. Dr. Slack brought over 20 years' experience in fibrosis and respiratory translational science and joined from GSK, where he served as Vice President and Head of Respiratory Biology. He was previously acting Chief Scientific Officer at Galecto. Over his career he has helped deliver multiple approved respiratory medicines, including vilanterol (Breo®, Trelegy®) and umeclidinium (Anoro®, Trelegy®) for asthma and COPD, and led the discovery of the inhaled avß6 inhibitor GSK3008348 for IPF. A Fellow of the Royal Society of Biology with more than 60 publications, he holds a PhD from the University of Strathclyde. New Risk • May 25
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 8.7% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 12% per year for the foreseeable future. Revenue is less than US$1m (kr3.5m revenue, or US$380k). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr563m net loss in 3 years). Share price has been volatile over the past 3 months (8.7% average weekly change). Shareholders have been diluted in the past year (20% increase in shares outstanding). Annuncio • Apr 02
Vicore Pharma Holding AB (publ), Annual General Meeting, May 06, 2026 Vicore Pharma Holding AB (publ), Annual General Meeting, May 06, 2026, at 15:00 W. Europe Standard Time. Location: baker mckenzie advokatbyra, on master samuelsgatan 17, floor 6, se-111 44 stockholm, stockholm Sweden Annuncio • Jan 02
Vicore Pharma Holding AB (publ)(OM:VICO) dropped from OMX Nordic Small Cap Index Vicore Pharma Holding AB (publ has been removed from OMX Nordic Small Cap Index . Annuncio • Nov 04
Vicore Pharma Holding AB (publ), Annual General Meeting, Jan 15, 2026 Vicore Pharma Holding AB (publ), Annual General Meeting, Jan 15, 2026. Annuncio • Nov 04
Vicore Pharma Holding AB (publ), Annual General Meeting, May 06, 2025 Vicore Pharma Holding AB (publ), Annual General Meeting, May 06, 2025. New Risk • Oct 09
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 110% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (14% average weekly change). Earnings are forecast to decline by an average of 26% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (110% increase in shares outstanding). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (kr328m net loss in 2 years). Annuncio • Sep 12
Vicore Pharma Holding AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 782.138028 million. Vicore Pharma Holding AB (publ) has filed a Follow-on Equity Offering in the amount of SEK 782.138028 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 111,734,004
Price\Range: SEK 7
Transaction Features: Rights Offering Annuncio • Sep 10
Vicore Pharma Holding AB Initiates the Global, Randomized Phase 2B Aspre Trial Evaluating the Disease-Modifying Potential of Buloxibutid in Idiopathic Pulmonary Fibrosis Vicore Pharma Holding AB announced initiation of the 52-week Phase 2b ASPIRE trial evaluating buloxibutid in IPF. The initiation follows clearance by the US Food and Drug Administration and other regulatory authorities to start the trial. Buloxibutid is a first-in-class angiotensin II type 2 (AT2) receptor agonist that activates an upstream mechanism promoting alveolar integrity and function with corresponding downregulation of aberrant alveolar repair and fibrosis in IPF. ASPIRE is a global 52-week Phase 2b, randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to assess the efficacy and safety of buloxibutid in IPF patients who are either untreated or receiving background nintedanib standard of care. Participants will be randomized to receive one of two doses of buloxibutid (100 mg or 50 mg taken orally twice daily) or placebo. The primary endpoint is change from baseline in forced vital capacity (FVC), the registrational endpoint for IPF. Key secondary endpoints include safety, tolerability, and the proportion of patients with disease progression over the trial period. The trial is expected to enroll 270 patients from over 90 sites across 14 countries, including the United States. This trial was developed in collaboration with world leading pulmonologists, patient advocacy organizations, and an advisory panel of IPF patients and caregivers. This Phase 2b trial will build on positive preclinical, translational, and clinical datasets, which suggest that buloxibutid protects type 2 alveolar epithelial cells, the progenitor cells responsible for maintaining alveolar homeostasis and promoting gas exchange in the lung. By promoting epithelial repair as well as reducing and resolving fibrotic tissue, buloxibutid has the potential to improve lung function, consistent with the effect seen in the Phase 2a AIR trial. In that trial, 36 weeks of treatment with buloxibutid improved FVC by an average of 216 mL from baseline, with a significant effect over the expected decline in untreated patients (n=28, p<0.001) [1,2]. Sixty-five percent of patients showed improved FVC, suggesting a robust treatment effect. Taken together with its excellent safety and tolerability profile, buloxibutid’s Phase 2a trial results reflect disease-modifying potential. Approximately three million people suffer from IPF worldwide. Current therapies are limited, often causing gastrointestinal side effects while only moderately slowing disease progression [3]. The current global market for nintedanib and pirfenidone is over $4 billion and continues to grow, despite modest benefit, poor tolerability, and the high discontinuation rates observed with these drugs [4]. If successful, buloxibutid has the potential to change standard treatment practices and provide a better tolerated, more effective therapy for patients. Vicore has engaged the contract research organization PSI to support the company in executing the Phase 2b ASPIRE study with the highest standards of quality and efficiency. Board Change • May 14
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Director Heidi Hunter was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Annuncio • May 08
Vicore Pharma Holding AB (Publ) Announces Board Appointments Vicore Pharma Holding AB (publ) at the annual general meeting held on 7 May 2024 approved the election of Yasir Al-Wakeel and Ann J. Barbier as members of the board of directors for the period until the end of the next annual general meeting. Hans Schikan was elected as the new chairman of the board of directors. Annuncio • Apr 04
Vicore Pharma Holding AB (Publ) Announces Maarten Kraan, as Board Member Declined Re-Election Vicore Pharma Holding AB (publ) announced that Maarten Kraan, as board member has declined re-election at its AGM, to be held on 7 May 2024. Annuncio • Mar 20
Vicore Announces FDA Breakthrough Device Designation for AlmeeTM, a Digital Therapy for Patients with Pulmonary Fibrosis Vicore Pharma Holding AB (publ) announced FDA Breakthrough Device Designation status for AlmeeTM, a 9-week digital cognitive behavioral therapy (CBT), to be used as an adjunct treatment of anxiety symptoms related to PF. The FDA Breakthrough Devices Program designates those medical devices that are evaluated as providing a more effective treatment for life-threatening or irreversibly debilitating diseases. Breakthrough designation reflects the effectiveness of this new therapy compared to treatment as usual for anxiety associated with pulmonary fibrosis and demonstrates the impactful nature of this digital therapy. Almee is a patient-facing tool based on CBT principles accessed via a smartphone or tablet. The COMPANION study on Almee demonstrated a 2.7-point improvement over control in GAD-7 (generalized anxiety disorder scale) and a 4.4 improvement in KBILD (King's Brief Interstitial Lung Disease) total score for quality of life. PF affects approximately 250,000 people in the United States[1], with increasing incidence[2]. Currently available therapies only slow the progression of this devastating and fatal disease. The physical burden of PF drives psychological impact with studies showing that 60% of patients with PF report having anxiety. Vicore plans to present Almee and the COMPANION study at a pulmonology conference in 2024. The company is seeking to advance Almee in partnership with the developers of approved and late- stage molecular therapies for the treatment of pulmonary fibrosis. "Almee represents the future of healthcare and is poised to deliver significant patient impact as an example of innovation in digital- molecular combination therapies," said Jessica Shull, PhD, Director of Digital Health at Vicore. Almee is subject to medical device regulation in the United States and Europe and is developed in partnership with Alex Therapeutics. Breakeven Date Change • Feb 28
No longer forecast to breakeven The 3 analysts covering Vicore Pharma Holding no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr318.4m in 2026. New consensus forecast suggests the company will make a loss of kr296.4m in 2026. New Risk • Feb 13
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 7.7% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr268m net loss in 3 years). Share price has been volatile over the past 3 months (7.7% average weekly change). Shareholders have been diluted in the past year (37% increase in shares outstanding). Annuncio • Jan 02
Vicore Pharma Holding AB (publ) Confirms IPF Development Program on Track and Provides Early-Stage Pipeline Updates Vicore Pharma Holding AB (publ) announced pipeline updates as the company continues to focus on development of C21 for idiopathic pulmonary fibrosis (IPF). The updates announced include confirmation that development of the lead program, C21 for IPF is on track, with final Phase 2a AIR data in the first half of next year. In addition, start-up activities for the global, double-blind, placebo-controlled, 52-week, Phase 2b ASPIRE study of C21 for IPF are progressing with initiation expected in the first half of 2024. Development of the Almee digital therapy advances as well, with topline results of the COMPANION pivotal study for anxiety associated with pulmonary fibrosis expected to be reported in January 2024. In its early-stage pipeline, as a result of an on-going portfolio review process that aims to focus investments, Vicore will discontinue development of the preclinical IMiD program, inhaled thalidomide for IPF cough. The review is also expected to select the best possible follow-on indications and ATRAG molecules for further development in view of the unique characteristics of this upstream mechanism of action that drives tissue repair. Annuncio • Dec 18
Vicore Pharma Holding AB (publ) Appoints Bertil Lindmark as Chief Medical Officer Vicore Pharma Holding AB (publ), announced that Dr. Bertil Lindmark, will join as Chief Medical Officer. A luminary in advancing respiratory medicines, Dr. Lindmark's distinguished career spans global leadership roles at major pharmaceutical organizations and pioneering biotechnology companies. Formerly Global Vice President, Clinical Development for Respiratory and Inflammation at AstraZeneca, Dr. Lindmark spearheaded the development of Symbicort and Pulmicort, among other globally renowned respiratory medicines, and as Head of Research and Development at Almirall, lead the global approval of the second to market long acting antimuscarinic for the treatment of COPD. His recent tenure as Chief Medical Officer at Galecto focused on leading major global clinical development efforts in IPF. Rohit Batta, outgoing Chief Medical Officer, has accepted a Managing Director role leading a Swiss biopharmaceutical venture company. As he transitions from his position, Vicore reinforces its commitment to develop life-changing treatments for patients suffering from lung diseases such as IPF through this appointment. Dr. Lindmark obtained his MD and PhD degree in molecular epidemiology from Lund University in Sweden, supervised by Professor Sten Eriksson, who described the alpha1-antitrypsin deficiency. Dr. Lindmark also served as visiting Professor in Innovation and Entrepreneurship at the Institute of Medicine at Gothenburg University. New Risk • Nov 28
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 6.5% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (55% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr268m net loss in 3 years). Share price has been volatile over the past 3 months (6.5% average weekly change). Annuncio • Oct 27
Vicore Pharma Holding AB (publ) Provides Update Regarding Phase 1 Study of C106 Vicore Pharma Holding AB (publ) announced that the Phase 1 study of C106 has concluded and that Vicore will not continue further development due to a transient increase in blood pressure observed at doses believed to be in the clinically effective range. The Phase 1 study of C106 (NCT05427253), initiated in June 2022, was designed as a double-blind, placebo-controlled, randomized first-in-human study to evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of the drug candidate from 5 to 300 mg. While there were no major safety signals or tolerability concerns in the doses tested, an increase in blood pressure was observed at twice-daily doses of 140 mg and higher. New Risk • Aug 31
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 14% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr314m free cash flow). Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (55% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr364m net loss in 2 years). Share price has been volatile over the past 3 months (7.2% average weekly change). Annuncio • Aug 22
Vicore Pharma Holding AB (publ) Reports Data from EndoPAT® Exploratory Trial Vicore Pharma Holding AB reported that its clinical study investigating the EndoPAT® technology as a tool to assess the effect of C21 on endothelial function is complete and that the data were inconclusive. The study was designed as a single-dose, double-blind, exploratory crossover trial to compare the ATRAG C21 with placebo in eleven patients with type 2 diabetes. However, the intra-individual variability in the EndoPAT® assessments was high, including between placebo and baseline readings in the primary measure, reactive hyperemia index score, resulting in inconclusive data. EndoPAT® is a diagnostic device that measures endothelium-dependent reflex hyperemia after short-term occlusion of the blood flow to the arm. It is a simple and non-invasive technique that if successful could have facilitated the comparison of efficacy of different ATRAGs and also for assessment of acute effects on endothelial function in various diseases. New Risk • Jul 19
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 55% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr309m free cash flow). Shareholders have been substantially diluted in the past year (55% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr180m net loss in 3 years). Share price has been volatile over the past 3 months (9.7% average weekly change). Annuncio • Jul 14
Vicore Pharma Holding AB (Publ) Announces Executive Changes Vicore Pharma Holding AB (publ) announced that the board of directors has resolved to appoint Ahmed Mousa as new CEO of the company with start in September 2023. This follows the July 5 announcement that Carl-Johan Dalsgaard plans to retire as CEO of the company. Ahmed Mousa is an experienced biotechnology executive with deep expertise in business and corporate development across several therapeutic areas, including respiratory disease. He joins the company from Pieris Pharmaceuticals where he served as Chief Business Officer. During his time at Pieris, Ahmed executed strategic partnerships yielding over USD 400 million in upfront, milestone, and co-development program investment, and over USD 6 billion in milestone potential with leading biopharmaceutical companies including AstraZeneca, Genentech, Seagen and Servier. He also played a leading role in growing Pieris from less than 30 employees in 2016 to approximately 150 in 2022 and in the advancement of multiple therapeutic programs from concept to clinical studies. Ahmed is a US citizen and resides in Boston, Massachusetts. Prior to joining Pieris, Ahmed was an attorney with the law firm Covington & Burling, where he represented pharmaceutical and biotech companies in a range of matters. He was previously a law clerk at the US Court of Appeals for the Third Circuit and an IP associate at the law firm Kirkland & Ellis. Ahmed obtained undergraduate degrees in molecular biology and government from Cornell University and a Master's degree in biotechnology from John Hopkins University with research experience focused in oncology, angiogenesis, and--notably--angiotensin II biology. He obtained a Juris Doctor degree from Georgetown Law with honors, where he was the Editor-in-Chief of the Georgetown Journal of International Law. Annuncio • May 20
Vicore Pharma Holding AB (publ) Reports New 36-Week Data from the Air Trial Demonstrating Sustainable Disease Stimulating the Potential of A New Class of Drugs to Stop Disease Propose and Restate in IPF Patients Vicore Pharma Holding AB (publ) announced an updated interim analysis of its AIR phase 2a trial with C21 in idiopathic pulmonary fibrosis (IPF). With 51 patients enrolled, the data demonstrates that C21 has the potential to transform the treatment of IPF and restore lung function. The disease is currently considered to be incurable and inevitably progressive. C21 continues to be safe and well tolerated with no treatment-related serious adverse events C21 continues to demonstrate long-term efficacy, at 36 weeks the average FVC had increased to +350 mL over baseline, which is +530 mL over the expected trajectory of untreated patients (n= 19; p=0.001). The data will be orally presented at the American Thoracic Society (ATS) international congress on May 21st and during a webcast on May 26th, including a Q&A session. Vicore plans to progress clinical development of C21 through initiation of a phase 2b trial (ANDAS) and will conclude recruitment to the AIR trial. The AIR trial, a multi-center, open label, single arm 24-week trial with a 12-week extension studying the safety and efficacy of the angiotensin II type 2 receptor agonist (ATRAG) C21 in patients with IPF, has now enrolled 51 patients. At the time of analysis, 27 patients had completed 24 weeks of treatment with an average increase in FVC of +50mL and a 3-visit average increase of +110 mL (p=0.007 versus the expected trajectory of untreated patients), and 19 patients had completed 36 weeks of treatment with an average increase in FVC of +350 mL and a 3-visit average increase of +220 mL (p=0.001 versus the expected trajectory of untreated patients). Out of the 19 patients that had completed 36 weeks of treatment, 17 presented an FVC value that was better than what would have been expected of an untreated population. The new dataset shows a stabilization of lung capacity already at week 6 and, in line with previous interim analysis, a subsequent increase of FVC from week 16 to 36. Now, with twice the number of patients versus the interim analysis announced in November 2022, the previously reported early stabilization followed by an increase in lung function is confirmed, suggesting that C21 has the potential to transform the treatment of IPF. C21 continued to be safe and well tolerated with no treatment-related serious adverse events; there was a low rate of disease progression or worsening of cough and no gastrointestinal tolerability issues. 94% and 96% of patients at week 12 and 24, respectively, showed a positive benefit/risk, according to a joint benefit/risk assessment by the patients and principal investigator. Recruitment to the AIR trial will be concluded to fully focus on the next step of development, the phase 2b ANDAS trial. Vicore has engaged world leading experts and patient advocacy organizations in its advisory committee to aid in the design and successful conduct of the trial. Biomarkers further validate C21 results: The clinical findings with FVC have been confirmed with relevant biomarkers, thereby increasing the confidence in C21. FVC correlated strongly with lung volume (p=0.001) as measured in 3D reconstructions of CT scans, reinforcing the accuracy of the FVC measurements. Furthermore, patients with early IPF disease showed significantly less end-terminal fibrosis in the scans (p<0.02) and a higher degree of FVC increase after 36 weeks of treatment compared to patients with established IPF. This is in line with the C21 mechanism of action, promoting alveolar repair. The biomarker TGFb1 was reduced from baseline by 57% at 24 weeks (n=18), suggesting a reduced fibrosis drive. TGFb1 is a key mediator of fibrosis and its reduction has consistently been seen in cell cultures, animal models as well as in slices of human IPF lung tissue exposed to C21. Annuncio • Dec 05
Vicore Pharma Holding AB (publ) Announces First Patient Enrolled in COMPANION; a Digital Therapeutic Pivotal Study for Patients with Pulmonary Fibrosis Vicore Pharma Holding AB (publ) ("Vicore") launched the pivotal phase of COMPANION, the first clinical investigation of a digital cognitive behavioral therapy (dCBT) for patients with pulmonary fibrosis. Patients with pulmonary fibrosis (PF) are given a poor prognosis, during which dyspnea, fatigue and cough gradually worsen. In a preceding study, it was shown that 63% of PF patients report treatable levels of anxiety. Vicore's digital Cognitive Behavioral Therapy has the advantage of being accessible 24/7 and can be personalized to meet the patient's individual needs and schedule. The COMPANION study is a fully digitalized, randomized, controlled parallel-group clinical investigation to evaluate the impact of the digital therapy Almee(TM) on the psychological symptom burden in adults diagnosed with PF. Patients enrolled in the investigation will be randomized to Almee(TM) or a treatment-as-usual control group, for nine weeks. Outcomes will be patient- and clinician-reported measures of anxiety using validated questionnaires. The COMPANION study, enrolling 250 patients across the US, is scheduled to complete in fourth quarter 2023. Provided the result is positive, Almee(TM) will be submitted for FDA clearance as a prescription medical device to be launched in 2024 with the intention to treat the anxiety symptoms in patients with pulmonary fibrosis. Annuncio • Nov 04
Vicore Pharma Holding AB (publ) Announces New Data from the IPF Air Trial Further Strengthening the Benefit-Risk Profile of C21 Vicore Pharma Holding AB provides a new interim analysis of the ongoing AIR trial, a phase 2a study in idiopathic pulmonary fibrosis (IPF). The AIR trial is a multi-center open label single arm 24-week trial with the addition of a 12-week extension study evaluating the safety and efficacy of the AT2R agonist (ATRAG) C21 in patients with IPF. After an interim analysis of 41 patients, the previously reported strong effect on lung function is reinforced still without safety concerns, suggesting a strong benefit-risk profile. The new dataset shows a stabilization of lung capacity already at week 6 and, as already seen in the previous interim analysis, a subsequent increase of forced vital capacity from week 18 to 36. The increase was more pronounced in IPF patients without end-stage destruction of lung parenchyma as documented by high resolution computer tomography. Annuncio • Oct 12
Vicore Selects New ATRAG as Next Drug Candidate Vicore Pharma Holding AB (publ) announced that the compound C103 has been selected as the company's third ATRAG drug candidate to move forward into toxicology studies and thereafter a phase 1 trial. In preclinical testing, C103 has shown a more than 40,000 times higher affinity for the angiotensin II type 2 receptor (AT2R) compared to the angiotensin II type 1 receptor (AT1R). The AT2R is a resolution and repair receptor whereas AT1R stimulation increases blood pressure and promotes inflammation and fibrosis. This profile makes C103 particularly suitable for indications such as preeclampsia where any AT1R stimulation is undesirable. The class of ATRAGs has so far shown a favorable safety profile, most likely because they stimulate an endogenous protective system and because AT2R is upregulated in disease while the expression is generally low in healthy tissue. C103, with expected patent protection until at least 2040, will next be tested in both general toxicology and safety pharmacology studies as well as reproduction toxicology studies. Preeclampsia is a tentative indication for C103 based on convincing preclinical data supporting a role for ATRAGs in this disease as well as the documented positive effects on blood flow in humans. It is a potentially very serious disease affecting 4.6% of pregnancies, and each year 76,000 women and 500,000 babies die worldwide. There is currently no treatment except lowering of blood pressure and, when necessary, premature delivery. The AT2R is part of the body's resolution and repair system and is suggested to be protective in several diseases connected to ageing and cell senescence, including idiopathic pulmonary fibrosis, chronic kidney disease, heart failure as well as cognitive disorders. Stimulating AT2R has been shown to be effective in combatting disease in numerous models and clinical validation is well advanced in acute and chronic lung disease. Stimulating AT2R also dilates small diseased resistance vessels in animals and in humans, resulting in locally increased blood flow. Vicore is developing C21 for rare lung diseases and has a series of new ATRAGs in development for other indications, the first of which (C106) is in clinical phase 1. Annuncio • Oct 06
Vicore Pharma Holding AB (publ) Announces Positive Results for the Pilot Phase of the COMPANION study Vicore Pharma Holding AB (publ) announced positive results for the pilot phase of the COMPANION study. The company's digital Cognitive Behavioral Therapy (CBT) therapy, AlmeeTM; for patients with pulmonary fibrosis was safe, functional, user-friendly and reduced anxiety symptoms by 49% in patients with idiopathic pulmonary fibrosis (IPF). The COMPANION Pilot study 1 was a four week, open-label, decentralized clinical investigation in 10 patients with self-reported symptoms of anxiety related to IPF. The primary objective of the study, to test the functionality, user experience and safety of the digital therapeutic (DTx), was met and preliminary efficacy results were encouraging; four weeks of using the DTx reduced GAD-7* scores by 4.2 points. A reduction in the GAD-7 score of 2 points is regarded as clinically meaningful. These results indicate that the DTx could serve as a safe and reliable resource for IPF patients to address the psychological impact of living with a severe disease. The pivotal phase of COMPANION will start in fourth quarter 2022, using a full implementation of the DTx product, AlmeeTM. It will be a 9-week, randomized, controlled, decentralized clinical investigation including 250 patients with all forms of pulmonary fibrosis. Topline read-outs from the pivotal investigation are scheduled for 2023. Annuncio • Sep 23
Vicore Pharma Holding AB Announces C21 Promotes Vascular Function in Humans Vicore Pharma Holding AB announced that intra-arterial administration of C21 results in a significant dose -dependent increase in local blood flow. Forearm blood flow was measured by plethysmography* in healthy volunteers after intra-arterial infusion of small increasing doses of C21[1] leading to local blood concentrations of C21 similar to those reached with oral C21 treatment. In the injected arm, blood flow increased by 63% (p=0.026), without reducing systemic blood pressure or causing other side effects. Vasodilation by angiotensin II type 2 receptor agonists (ATRAGs) is mediated by nitric oxide (NO) released from the endothelium, and the observed effects show that this can be achieved in man with clinically relevant doses of C21. Annuncio • Sep 16
Vicore Pharma Holding AB (Publ) Provides an Update on the Attract-3 Covid-19 Trial Vicore Pharma Holding AB (publ) announces the top-line data from the ATTRACT-3 trial in hospitalized COVID-19 patients. In ATTRACT-31, a global phase 3 trial, 272 hospitalized patients in need of oxygen supplementation were treated with 100 mg C21 twice daily or matching placebo for 14 days. The primary endpoint, reduction in overall mortality at 60 days was not met, nor were the secondary efficacy endpoints related to disease progression and discharge. Vicore will discontinue further clinical development of C21 in COVID-19. In the phase 2 ATTRACT trial2, conducted when the wild-type SARS-COV-2 virus was causing COVID-19, C21 treatment resulted in a significant restoration of lung function as well as a reduction of long-term lung injury. The wild-type virus was unique in that it infected alveolar epithelial cells deep into the lung parenchyma, resulting in a distinct clinical pattern and a pathogenesis very similar to idiopathic pulmonary fibrosis (IPF)3. In contrast, the later virus mutations, and especially the Omicron variant that became predominant during the ATTRACT-3 trial period, reproduces more superficially in the bronchial mucosa in the upper airways giving rise to a much milder diseas. This change of virus characteristics could not be foreseen and explains the differences in disease pattern and why targeting alveolar integrity and function with C21 was not effective in treating the disease or to reduce mortality in the ATTRACT-3 trial. The AT2R is part of the body’s regeneration and repair system and is suggested to be involved in several diseases connected to ageing and cell senescence, including idiopathic pulmonary fibrosis, chronic kidney disease, heart failure as well as cognitive disorders. Stimulating the AT2R has been shown to be effective in combatting disease in numerous models and clinical validation is well advanced in acute and chronic lung disease. Stimulating AT2R also dilates small diseased resistance vessels in animals and in humans, resulting in locally increased blood flow. In the lungs, the AT2R is highly expressed in the alveolar epithelium while it is absent in the bronchial mucosa. ATTRACT-3 is a randomized, double-blind, placebo-controlled, multinational, phase 3 trial with 272 adult patients hospitalized with COVID-19 requiring oxygen support but not mechanical ventilation. The primary endpoint is all-cause mortality up to day 60. Patients were randomized to receive 100 mg C21 or placebo twice daily on top of standard of care for 14 days and be followed for 60 days. Annuncio • Jun 16
Vicore Pharma Holding AB (publ) Announces Initiation of First-In-Human Trial with the Novel ATRAG C106 Vicore Pharma Holding AB (publ) announced initiation of a first-in-human trial with the novel ATRAG C106. The trial is expected to read out during First Quarter 2023. Vicore's C106 is the first of four advanced candidate drugs from the VP03 program to enter clinical trials. C106 and the three additional candidates are small molecules with high affinity for the AT2R and intended for indications also outside rare lung disease. C106 is orally available with target engagement and anti-fibrotic effects in human fibrotic lung and kidney tissue at clinically relevant concentrations. C106 is expected to have patent protection until at least 2040. This first-in-human trial is a double-blind, placebo-controlled, randomized, single-center trial to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of C106. The trial is expected to include approximately 72 healthy volunteers and will be performed in Uppsala, Sweden. Annuncio • Jun 03
Vicore Pharma Holding AB (publ) Amends Primary Endpoint to Accelerate the Phase 3 Trial in COVID-19 Patients Vicore Pharma Holding AB (publ) announced an amendment of the ongoing COVID-19 Phase 3 trial (ATTRACT-3). In response to the current dominance of the weaker Omicron variant of the SARS-CoV-2 virus, leading to fewer hospitalizations, Vicore has gained FDA endorsement to revise the hierarchy of endpoints in the ongoing ATTRACT-3 trial*. The revised primary endpoint, all-cause mortality up to day 60, is supported by the previously reported Phase 2 trial (ATTRACT) results, is clinically relevant and adopted to the study population. In the ATTRACT trial, C21 restored respiratory function and improved disease severity, as demonstrated by 1) a significant reduced need of oxygen supplementation, 2) a reduced number of patients needing mechanical ventilation, 3) a reduction in mortality and 4) a clinically and statistically significant reduction of NT pro-BNP, a strong biomarker predicting severity and mortality in COVID-19. These results have positioned C21 as a treatment for hospitalized patients with moderate to severe COVID-19 to restore respiratory function and prevent progression of severity and mortality. The ATTRACT-3 trial is approaching 300 patients enrolled and includes a large initial population of unvaccinated patients infected by the Delta variant, justifying the change to a mortality endpoint and to complete the trial with this sample size. Top-line data will be presented in third quarter 2022. AT2R is part of the body's regeneration and repair system and is suggested to be involved in several diseases connected to ageing and cell senescence including idiopathic pulmonary fibrosis, chronic kidney disease, heart failure and cognitive disorders. Stimulating the AT2R have been shown to be effective in several disease models and the clinical validation is under way in acute and chronic lung disease. Stimulation of AT2R can also dilate small resistance vessels in animals and man to locally increase blood flow. Annuncio • Apr 21
Vicore Launches COMPANION, A Clinical Study Investigating the Benefit of Digital Therapy on Anxiety in Patients with Idiopathic Pulmonary Fibrosis Vicore Pharma Holding AB announced the first patient enrolled in the pilot phase of COMPANION, a clinical study of a digital cognitive behavioral therapy for patients with IPF. Patients with IPF have a life expectancy of three to five years, during which dyspnea, fatigue and cough gradually worsen and in a preceding study, it was shown that 63% of IPF patients report a moderate to severe level of anxiety. Cognitive behavioral therapy (CBT) is a well-established method to help patients with the psychological burden caused by severe disease and a digital CBT has the advantage of being accessible around-the-clock and can be personalized to meet the patient's needs. COMPANION is a fully digitalized, randomized, controlled parallel-group clinical study to evaluate the impact of the digital therapy Almee) on the psychological symptom burden in adults diagnosed with IPF. The COMPANION study consists of two phases; a pilot study designed to refine the interactive nature of the therapy session, followed by a pivotal study. The study will take place in the US and is expected to conclude in first half of 2023, after which Vicore will seek FDA clearance for Almee(TM) as a medical device and is expected to be made available to patients in 2024. Almee(TM) is developed in collaboration with Alex Therapeutics AB and the COMPANION study is conducted using virtual clinical solutions developed by Curebase Inc. Annuncio • Mar 10
Vicore Pharma Holding AB (Publ) Announces Plans to Initiate A Clinical Trial with C21 in PAH Vicore Pharma Holding AB (publ) announced plans to initiate a clinical trial with C21 in PAH. Pulmonary arterial hypertension (PAH) is a rare lung disease with huge unmet medical need where existing medicines reduce the pressure by dilating the vessels without changing underlying disease or survival. Both PAH and the pulmonary hypertension associated with idiopathic pulmonary fibrosis come with pulmonary vascular dysfunction contributing to progression of disease and finally cardiac failure. Vicore has generated preclinical data in pulmonary hypertension models showing that C21 reverses vascular remodelling and significantly improves hemodynamics. In combination with the vascular effects demonstrated in the mechanistic clinical trial in systemic sclerosis patients, the data supports clinical development in PAH. C21 reduces the pro-fibrotic factor TGFß in human IPF lung tissue and the established role of TGFß in the development of PAH further strengthens the hypothesis. If development is successful, C21 would likely enjoy orphan drug status protection in the US and in Europe. To assist in design and evaluation of the planned trial, the company has appointed two experts in the field as clinical advisors: Professor Chris Denton and Dr. Gerry Coghlan. Chris Denton is a professor in experimental rheumatology at UCL Medical School and Joint Director of the Centre for Rheumatology, Royal Free Hospital, London. He runs the largest scleroderma service in the UK with more than 1000 scleroderma patients and has published extensively on laboratory and clinical aspects of Raynaud's phenomenon, connective tissue disease and pulmonary hypertension. Gerry Coghlan is a cardiologist and leads the national pulmonary hypertension service at Royal Free Hospital. He is a founding member and ex-chair of the National Pulmonary Hypertension Physicians Association and has developed the Royal Free National Pulmonary Hypertension Service, with a particular interest in connective tissue disease associated pulmonary hypertension. Annuncio • Feb 24
Vicore Pharma Holding AB (Publ) Announces Advancing its First New Chemical Entity from the VP03 Program to a First in Human Phase 1 Trial Vicore Pharma Holding AB (publ) announced advancing its first new chemical entity from the VP03 program to a first in human phase 1 trial. This molecule is the company's first AT2R agonist to follow C21 in clinical development. Building on its specific expertise Vicore announces that the first candidate in the VP03 program has completedpreclinical development and is ready to enter the clinical development phase. A clinical trial application isplanned to be submitted during Second Quarter 2022. The compound C106 shows high selectivity for AT2R and good activity in reducing TGFb in human tissue. Further, four additional AT2R agonistic compounds are expected to finalizepreclinical evaluation during 2022. Annuncio • Feb 10
Vicore Pharma Holding Announces Data from an Interim Analysis of the Phase 2 Proof-of-Concept Study in IPF Vicore Pharma Holding AB announced data from an interim analysis suggesting that C21 stabilizes disease and increases lung function in idiopathic pulmonary fibrosis (IPF) patients as quantified by standard FVC (Forced Vital Capacity) measurement. An interim analysis of the phase 2 proof-of-concept study in IPF (the AIR1study) showed an initial stabilization of disease and then an increase in FVC up to the end of the study at 36 weeks. At the time of the interim analysis, there were 21 evaluable patients of which 13, 9 and 7 patients reached 12, 24 and 36 weeks of treatment, respectively. After 24 weeks, the increase in mean FVC was +251 ml, a considerable difference of 371 ml compared to the expected decline of 120 ml in 24 weeks in an untreated population. Five of the seven patients who completed both 24 and 36 weeks of C21 treatment showed continued improvement in FVC and two remained stable. Analysis of FVC slope values at 28, 32 and 36 weeks are statistically significant (p=0.016 at 36 weeks) compared to the expected mean for untreated patients. The study drug was well tolerated with no related serious adverse events, acute exacerbations, or gastrointestinal signals. The AIR study is an open label single arm study in treatment naïve IPF patients in which 100 mg of C21 was administered twice daily for 24 weeks with an optional 12-week extension. The study is being conducted in the UK, India, Ukraine, and Russia. A correct diagnosis was secured by central reading of high-resolution computer tomography (HRCT). To assess lung volume, the gold standard for FVC measurements, the ERT system, was used at all sites. With these results, the company initiates the planning of AIR 2, a double-blind controlled phase 2 dose-finding study to confirm these results and accelerate the development of C21 in parallel to completing the AIR trial. Annuncio • Sep 19
Vicore Pharma Holding AB (publ) Starts Dosing of First Covid-19 Patients in the Global Phase 3 Trial ATTRACT-3 Vicore Pharma Holding AB (publ) announced the dosing of the first patients in the company's global phase 3 trial of C21 in COVID-19 (ATTRACT-3). Previously reported positive phase 2 trial results strongly support further evaluation of the Vicore AT2 receptor agonist C21 in COVID-19. The pivotal phase 3 trial is currently approved in the US, Ukraine, South Africa, Brazil, Czechia, Philippines and India to investigate the efficacy and safety of C21 in hospitalized patients with COVID-19. ATTRACT-3 is the pivotal trial in which C21, an angiotensin II type 2 receptor (AT2R) agonist, is tested for the treatment of COVID-19 with the objective of generating key efficacy and safety data for assessment by regulatory bodies, including the US FDA. The first doses have now been administered and currently 9 sites are initiated in the US, Ukraine, Brazil and South Africa. ATTRACT-3 is a randomized, double-blind, placebo-controlled, multinational, phase 3 trial which will include 600 adult patients hospitalized with COVID-19 requiring oxygen support but not mechanical ventilation. The primary objective is to evaluate the effect of C21 on recovery from COVID-19. Vicore's phase 2 trial in COVID-19 (ATTRACT) showed that C21 significantly reduced the extended need for supplemental oxygen therapy, indicating faster recovery for patients treated with C21 compared to placebo. In ATTRACT-3, patients will be randomized to receive 100 mg C21 or placebo twice daily on top of standard of care for 14 days and be followed for 60 days. Trial start-up activities are ongoing at more than 40 clinical sites globally. Topline results from ATTRACT-3 are expected during the first half of 2022. Breakeven Date Change • Aug 01
No longer forecast to breakeven The 2 analysts covering Vicore Pharma Holding no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr47.9m in 2022. New consensus forecast suggests the company will make a loss of kr58.6m in 2023. Board Change • Jul 31
High number of new directors Chairman Michael Jensen was the last director to join the board, commencing their role in 2020. Annuncio • Jun 12
Vicore Pharma Holding AB (publ) Announces FDA Acceptance for Pivotal Phase 3 Trial of C21 in COVID-19 Vicore Pharma Holding AB (publ) announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for the company's lead asset, the orally available angiotensin II type 2 receptor (AT2R) agonist C21, for the treatment of COVID-19. The active IND enables initiation of US sites in Vicore's pivotal phase 3 trial, ATTRACT-3. ATTRACT-3 trial is a randomized, double-blind, placebo-controlled, multinational, phase 3 trial that will include 600 adult patients hospitalized with COVID-19 requiring oxygen support but not mechanical ventilation. The primary objective is to evaluate the effect of C21 on recovery from COVID-19. Vicore's Phase 2 trial (ATTRACT) in COVID-19 showed that C21 significantly reduced the extended need for supplemental oxygen therapy, indicating faster recovery on C21 compared to placebo. In ATTRACT-3, patients will be randomized to receive 100 mg C21 or placebo twice daily on top of standard of care (SoC) for 14 days and patients will be followed for 60 days. Trial preparations are currently ongoing in countries in North America, South and Central America, Europe, Africa and Asia. Topline results from ATTRACT-3 are expected during the first quarter of 2022. C21 in COVID-19 - improved respiratory outcomes: Results from the phase 2 ATTRACT study on 106 hospitalized patients with COVID-19, showed a significantly reduced risk for the need of supplemental oxygen (90% compared to placebo at day 14; P=0.003) and numerically fewer deaths and cases of patients requiring mechanical ventilation. C21, a first-in-class AT2R agonist: C21 is a first-in-class, orally available, low molecular weight, angiotensin II type 2 receptor (AT2R) agonist that activates the "protective arm" of the renin-angiotensin system (RAS). The compound has shown robust effects in human idiopathic pulmonary fibrosis (IPF) lung slices and a phase 2 proof-of-concept study in IPF is currently ongoing. Given that AT2R agonism has therapeutic potential in several additional indications with significant unmet medical needs, Vicore has intensified the efforts to develop proprietary follow-up molecules with differentiated profiles. Annuncio • Mar 12
Vicore Pharma Holding AB (Publ) Announces Top Line Data from A Phase Ii Study of Its Oral Angiotensin II Type 2 Receptor (AT2R) Agonist C21 in Patients with Systemic Sclerosis and Raynaud's Phenomenon Vicore Pharma Holding AB (publ) announced top line data from a phase II study of its oral angiotensin II type 2 receptor (AT2R) agonist C21 in patients with systemic sclerosis and Raynaud's phenomenon. In this mechanistic 12-person single-dose study, C21 did not reach the predefined area-under-curve endpoint but at the end of the measurement C21 treatment showed statistically significant evidence of restored skin temperature as a measure of dilated peripheral resistance vessels. The trial (NCT04388176) assessed the effect of a single dose of highly specific AT2R agonist C21 on cold-induced vasoconstriction, so called Raynaud's phenomenon, in patients with systemic sclerosis. The mechanistic study examined the role of the AT2R in acute improvement of blood flow in fibrotic tissues. Twelve patients with systemic sclerosis and Raynaud's phenomenon had both hands subjected to a challenge with cold water and the recovery periods on drug or on placebo were compared. Patients on C21 showed a robust and statistically significant (p=0.04) higher skin temperature 15 minutes after the cold challenge. The new clinical results support the multi-faceted utility of C21 in the treatment of pulmonary fibrosis and related vasculopathies that would benefit not only from increased blood flow in fibrotic tissue (current trial), but also from the previously documented inhibition of the profibrotic growth factor TGF-beta1 in human IPF lung tissue ex vivo, as well as the reduced microvascular remodeling and pulmonary hypertension seen in relevant disease models in vivo. C21 (VP01 program), a first in class AT2R agonist C21 is a first in class orally available low molecular weight angiotensin II type 2 receptor (AT2R) agonist. It is under development for idiopathic pulmonary fibrosis (IPF) and was recently reported to show beneficial effects in COVID-19 in which a phase 3 study is currently being planned. Annuncio • Feb 26
Vicore Pharma Holding AB (Publ) Resumes VP02 Production Vicore Pharma Holding AB (publ) informed about a delay in the production of inhaled formulation of thalidomide due to technical issues with the CMO. The issues have been solved and the company estimate to submit a CTA for a phase I study by the end of 2021. Annuncio • Feb 10
Vicore Pharma Holding AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 336 million. Vicore Pharma Holding AB (publ) has completed a Follow-on Equity Offering in the amount of SEK 336 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 11,200,000
Price\Range: SEK 30
Transaction Features: Subsequent Direct Listing Annuncio • Feb 01
Vicore Pharma Holding AB Announces Positive Data from Phase II Study Attract in Patients with Covid-19 Published Online Vicore Pharma Holding AB (publ) published data from the phase II study ATTRACT online and submitted it to a peer reviewed journal. The results show restoration of lung function in COVID-19 on top of corticosteroids and remdesivir with the company's oral drug C21, suggesting that C21 can become an important complement to vaccines to combat the COVID-19 pandemic. With close to 100 million registered cases and 2 million deaths to date, there is an urgent need for a safe oral effective therapy to complement the recently launched vaccines. Vicore Pharma's angiotensin II type 2 receptor (AT2R) agonist C21 showed restoration of respiratory function with a significantly lower risk of being on supplemental oxygen at the end of treatment and during follow up. In the ATTRACT study (Angiotensin II Type Two Receptor Agonist COVID -19 Trial), a randomized, double-blind and placebo-controlled trial, a total of 106 hospitalized patients with a diagnosis of coronavirus SARS-CoV-2 infection (confirmed by polymerase chain reaction test) and signs of an acute respiratory infection but not requiring mechanical ventilation were recruited. The patients were randomized to receive oral treatment with C21 (100 mg b.i.d., n=51) or placebo (n=56) for seven days on top of standard of care (physician's choice) with a follow up after 7-10 days. According to data analyzed to date, the treatment groups were well balanced regarding age, sex and concomitant medications. Importantly, the vast majority of patients received corticosteroid treatment. C21 is a first-in-class orally available low molecular weight angiotensin II type 2 receptor (AT2R) agonist that activates the "protective arm" of the renin-angiotensin system (RAS). The compound has shown robust effects in human IPF lung slices, and a phase II proof-of -concept study in IPF has recently started. Given that AT2R agonism has therapeutic potential in a number of additional indications with significant unmet needs, Vicore has intensified the efforts to develop proprietary follow-up molecules with different profiles. Is New 90 Day High Low • Dec 23
New 90-day high: €2.82 The company is up 55% from its price of €1.83 on 24 September 2020. The German market is up 7.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is down 6.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €14.05 per share. Annuncio • Dec 21
Vicore Pharma Holding Reports an Expanded Data Analysis to Follow Up the Encouraging Top Line Data from the ATTRACT Vicore Pharma Holding AB (publ) reports an expanded data analysis to follow up the encouraging top line data from the ATTRACT study reported on December 8, 2020. The data show restoration of lung function in COVID-19 with the company's oral lead candidate drug C21, suggesting that C21 can become an important complement to vaccines to combat the COVID-19 pandemic. With COVID-19 increasing world-wide, with more than 600,000 new cases and 10,000 deaths registered per day, there is an urgent need for a safe oral effective therapy as an important complement to the recently launched vaccine efforts. Annuncio • Dec 16
Vicore Pharma Holding AB (Publ) Announces Last Patient Last Visit in the Mechanistic Phase II Study with C21 in Systemic Sclerosis Vicore Pharma Holding AB (publ) announced that the last patient has completed the final visit in the mechanistic phase II study of Raynaud’s phenomenon in systemic sclerosis patients. he trial is designed to study the effect of a single dose of C21 on cold-induced vasoconstriction, so called Raynaud’s phenomenon (RP), in patients with systemic sclerosis (SSc). It may shed light on the AT2 receptor’s role in acute improvement of blood flow in affected tissues. If the results are positive, the study will further support that C21 may also have beneficial effects on the pulmonary vascular pathology often seen in patients with SSc related pulmonary fibrosis as well as in idiopathic pulmonary fibrosis (IPF). The original study was planned to recruit up to 16 patients but due to the challenges caused by COVID-19 it was decided to stop at the minimally required patient number. SSc is a disease with a substantial involvement of angiotensin II and upregulation of the angiotensin II type 2 receptor (AT2R - the target for C21) which is known to mediate both anti-fibrotic and beneficial vascular effects in several models of pulmonary fibrosis and pulmonary hypertension. SSc is a rare and severe chronic autoimmune disease affecting skin as well as inner organs such as the lung and kidney. There is no cure for the disease and severe cases are treated with potent immunomodulatory drugs or, in some cases, autologous stem cell transplantation, nevertheless challenges and unmet medical need persists. The prevalence of SSc is estimated at 7-34 and 14-44 per 100,000 individuals in Europe and North America, respectively. The incidence is estimated to be 1-2 and 1-6 per 100,000 individuals in Europe and North America, respectively. SSc is 3-4 times more common in women than in men. It is estimated that 20 percent of the SSc patient population have the severe diffuse form. Between 30 and 50 percent of patients also suffer from interstitial lung disease. C21 is a first in class orally available low molecular weight angiotensin II type 2 receptor (AT2R) agonist that activates the protective arm of the renin-angiotensin system (RAS). It is further under development for idiopathic pulmonary fibrosis (IPF) and was recently reported to show beneficial effects in COVID-19 patients. Annuncio • Dec 10
Vicore Pharma Reports Positive Top Line Data from the ATTRACT clinical study in patients with COVID-19 Vicore Pharma Holding AB (publ) announces positive top line data from the ATTRACT COVID-19 trial with C21 (VP01). Topline results are; C21 reduced the risk of needing oxygen at the end of treatment by 40 %, an effect that was statistically significant (p=0.057) at the 10% level as predefined in the Statistical Analysis Plan, There was a clear trend for C21 reducing number of patients needing mechanical ventilation, with four patients in the placebo group compared to one in the C21 group, There was also a trend for C21 reducing mortality, with three deaths in the placebo group compared with one in the C21 group and C21 was well tolerated in this population of severely sick patients. Is New 90 Day High Low • Nov 25
New 90-day low: €1.78 The company is down 7.0% from its price of €1.92 on 27 August 2020. The German market is up 1.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Biotechs industry, which is down 8.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Annuncio • Nov 16
Vicore Pharma Holding AB Recruits the First Patient in the Phase II Proof-Of-Concept Study in Idiopathic Pulmonary Fibrosis Vicore Pharma Holding AB announced that the first patient in the phase II idiopathic pulmonary fibrosis (IPF) study has been recruited in India. The study is a phase II, multi-center, open-label, single-arm trial investigating the safety, effect on lung function and pharmacokinetics of C21 in 60 subjects with IPF. Patients will be treated with C21 twice daily for six months, with an option to continue treatment for another three months. C21, a first-in-class low molecular weight angiotensin II receptor type 2 (AT2R) agonist, activates the "protective arm" of the Renin-Angiotensin system (RAS). The primary indication for C21 is IPF, but it is also being studied in Raynaud's phenomenon in patients with systemic sclerosis as well as in acute COVID-19. The RAS is understood to play a role in regulation of fibrosis. C21 has previously shown effects in the bleomycin and monocrotaline pulmonary fibrosis/pulmonary hypertension (PH) models as well as in the severe Sugen-hypoxia PH model in the rat. In addition, C21 was recently shown to effectively inhibit TGFb1, a key regulator of fibrosis, in lung tissue from an IPF patient undergoing lung transplantation. Annuncio • Oct 04
Vicore Pharma Holding AB (Publ) Announces Completion of Patient Enrollment in the Covid-19 Attract Trial Vicore Pharma Holding AB (publ) announced that the last patient has been randomized in the ATTRACT COVID-19 VP01 trial. The last patient in the ATTRACT (Angiotensin II Type Two Receptor Agonist Covid-19 Trial) study has now been randomized and will be treated for up to one week and then followed up for another week. Thereafter, the data is quality controlled and the database will be locked before the study is unblinded for analysis. Top-line results are expected to be available before year end as previously announced. ATTRACT is a randomized, double-blind, placebo-controlled trial in 106 hospitalized COVID-19 patients with an intense inflammatory drive in the lungs which can develop into acute respiratory failure if it progresses. The patients, who are not on mechanical ventilation at randomization, receive oral treatment with 100 mg of VP01 (C21) or placebo twice daily for seven days. The primary objective with the study is to investigate efficacy of VP01 on inflammation, ventilation and other functional parameters. VP01, a first in class AT2R agonist VP01 (C21) is a first in class orally available low molecular weight angiotensin II type 2 receptor (AT2R) agonist that activates the "protective arm" of the renin-angiotensin system (RAS). It is under development for idiopathic pulmonary fibrosis (and is also being studied in Raynaud's phenomenon in patients with systemic sclerosis. Internal preclinical findings with VP01 suggested that it may also be useful in the treatment of COVID-19. VP01 could bypass negative effects of COVID-19 The RAS is understood to play an important role in the development of COVID-19 because angiotensin II (Ang II) is upregulated and contributes to the inflammatory reaction in the lungs. Moreover, the protective arm of the RAS is disarmed by SARS-CoV-2 which binds to the enzyme angiotensin converting enzyme 2 (ACE2) and thereby inhibits the conversion of Ang II to endogenous protective molecules stimulating the AT2R. Because VP01 directly stimulates the AT2R, it may bypass the negative effects of viruses like SARS-CoV-2 on the protective RAS functions. Annuncio • Sep 26
Vicore Pharma Holding AB (publ) Announces Robust Effects of VP01 in Human Idiopathic Pulmonary Fibrosis Lung Tissue Vicore Pharma Holding AB (publ) announced effects of VP01 on idiopathic pulmonary fibrosis (IPF) patient tissue. Fresh human IPF lung tissue harvested from a patient during lung transplantation showed stable expression of the VP01 target, the angiotensin type 2 receptor (AT2R), and treatment with clinically relevant concentrations of VP01 caused a dose-dependent decrease of TGFb1, a key growth factor in fibrosis development. VP01 (C21) is a first in class orally available low molecular weight AT2R agonist that activates the protective arm of the renin angiotensin system (RAS). The compound has previously shown effects in the bleomycin and monocrotaline pulmonary fibrosis/pulmonary hypertension (PH) models as well as in a severe PH model in the rat. VP01 is currently in clinical development for IPF, pulmonary fibrosis in systemic sclerosis and COVID-19. Harvesting fibrotic IPF lung tissue during lung transplantation gives the opportunity to culture precision cut slices as explants to study pharmacological effects on various markers of fibrosis development. To study human tissues affected by IPF gives a good opportunity to assess biomarkers that also can be followed in clinical studies. VP01 (C21) is being developed for the treatment of idiopathic pulmonary fibrosis (IPF), pulmonary fibrosis in systemic sclerosis (SSc) and COVID-19. VP02 is based on a new formulation and delivery route of an existing immunomodulatory compound (IMiD). VP02 focuses on the underlying disease and the severe cough associated with IPF. VP01 and VP02 are also being actively evaluated for other indications within the field of interstitial lung diseases where there are significant unmet needs. VP03 includes follow-up molecules for VP01. 
