공시 • Apr 30
Biophytis S.A. announced delayed 20-F filing On 04/29/2025, Biophytis S.A. announced that they will be unable to file their next 20-F by the deadline required by the SEC. 공시 • Apr 10
Biophytis S.A. Confirms the Launch of the Phase 2 Oba Clinical Trial in Obesity Biophytis SA confirmed the launch of the Phase 2 OBA clinical study in obesity, expected to begin as early as possible in 2025. Following the recent 2.6 million capital increase announced on March 26, 2025, and promising preclinical results presented at the 15th International Conference on Frailty and Sarcopenia in Toulouse, Biophytis will continue the clinical development of BIO101 in obesity. The goal is to evaluate the efficacy and safety of BIO101 in reducing muscle strength loss caused by GLP-1 agonists in patients with obesity. As a reminder, Biophytis received Investigational New Drug (IND) clearance from the FDA in July 2024, marking a major milestone for the OBA program, which benefits from the expertise of Professor Marc-Andr Cornier, a world-renowned expert in the field of obesity. 공시 • Jul 11
Biophytis SA Obtains IND Approval from the FDA to Start Its Phase 2 Oba Study in Obesity Biophytis SA announced that it has received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) for its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone). The primary objective of the study is to measure the improvement in muscle strength in the lower limbs, as assessed by knee extension test. Secondary endpoints will include analysis of mobility (via the 6-minute walk test) and body composition (assessment of fat and lean mass). A world-renowned medical expert in the field of obesity and President-elect of the American Obesity Society, Marc-Andre Cornier, Professor of Medicine and Director of the Endocrinology, Diabetes and Metabolic Diseases Unit at the Medical University of South Carolina, will be the principal investigator of the phase 2 OBA study. The multicenter study is due to start mid-2024 in the USA and could be extended to Europe. Preliminary results on the efficacy of BIO101 (20- hydroxyecdysone) are expected in 2025. Biophytis is seeking funding and partnerships to complete this study. 공시 • May 17
Biophytis S.A., Annual General Meeting, Jun 24, 2024 Biophytis S.A., Annual General Meeting, Jun 24, 2024. Location: sorbonne universite, 4 place jussieu, paris France 공시 • May 15
Biophytis SA Announces the Design of its Phase 2 OBA Clinical Study in Obesity Biophytis SA announced the design of its phase 2 OBA clinical study in obesity with BIO101 (20-hydroxyecdysone). BIO101 (20- hydroxyecdysone) will be evaluated in obese patients treated with GLP-1 RAs, together with hypocaloric dieting. The OBA phase 2 study will test the efficacy and safety of BIO101 (20- Hydroxyecdysone) in patients with obesity and overweight with secondary comorbidities, who are starting treatment with GLP-1 R As for weight loss. The OBA Phase 2 study is a double-blind, randomized, placebo-controlled clinical study in which 164 patients are planned to be enrolled with obesity (BMI 30) or overweight (BMI 27 with one or more sequalae e.g. diabetes, hypertension) at the start of treatment with GLP-1RAs in combination with hypocaloric diet. Double-blind treatment with 350 mg BID of BIO101 (20 -hydroxyecdysone) will been given for 21 weeks. The primary efficacy endpoint is muscle strength as measured by knee extension, and important secondary outcomes include 6 Minute Walking Distance and other performance tests, muscle strength normalized to lean body mass, abdominal lean mass and fat mass, biomarkers and various Patient-Reported Outcomes (PROs). Biophytis is preparing for filing an Investigational New Drug (IND) to start the OBA Phase 2 study in the USA in the coming weeks. The OBA Phase 2 clinical study is expected to start mid 2024, upon regulatory approvals, with first patients expected to be treated in the second half of 2024. First results of the safety and efficacy of BIO101 (20 thehydroxyecdysone) drug candidate are expected to be available in 2025. 공시 • Apr 27
Biophytis S.A.(OTCPK:BPTS.Y) dropped from NASDAQ Composite Index Biophytis SA has been dropped from NASDAQ Composite Index 공시 • Apr 19
Biophytis SA Announces Formation of New Scientific Advisory Board for Its Phase 2 OBA Clinical Study in Obesity Biophytis SA announced the formation of a new Scientific Advisory Board to support the advancement of its phase 2 OBA clinical study in obesity. This Scientific Advisory Board will be composed of a few worldwide medical experts in the field of obesity, including Professor Dennis Villareal from the USA and Professor Francisco Guarner from Spain. The OBA SAB will guide the company to develop BIO101 (20-hydroxyecdysone) in obesity, in combination with GLP1-RA, and will actively work towards the finalization of the OBA Phase 2 clinical study design. Biophytis plans to file for an Investigational New Drug (IND) application to start the OBA Phase 2 clinical study in the USA with FDA in the coming weeks. The first two members of Biophytis' new Scientific Advisory Board for the OBA clinical study are: Prof. Dennis T. Villareal, MD, PhD, a Professor of Medicine-Endocrinology, Diabetes and Metabolism at Baylor College of Medicine, Houston, Texas, United States.He is a physician-scientist with specialty training in geriatrics and endocrinology. He has extensive clinical and research experience in examining the impact of lifestyle interventions in reversing frailty in older adults with obesity. His clinical and translational laboratories involve hormonal, nutritional, and behavioral/lifestyle interventions to retard or reverse the metabolic and physical complications of aging, including sarcopenia and type 2 diabetes. He is dedicated to research designed to inform practice guidelines with respect to optimal treatment strategies for older adults with obesity. Prof. Francisco Guarner, MD, PhD, a Professor of Internal Medicine, Gastroenterology and Hepatology at the Hospital Clinic in Barcelona and at the University Clinic of Navarra. He is well known for his research studies on liver cell cytoprotection with prostaglandins. He has been Visiting Scientist and Research Fellow at the Upjohn Company in Kalamazoo (Michigan), the Royal Free Hospital (London), the King's College Hospital (London), and the Wellcome Research Laboratories (Beckenham). He is currently Consultant of Gastroenterology at the Digestive System Research Unit and Head of the Experimental Laboratory in University Hospital Vall d'Hebron (Barcelona). He is a member of the Scientific Committee of the Research Institution of University Hospital Vall d'Hebron (Barcelona). 공시 • Apr 09
Biophytis SA Launches OBA Phase 2 Clinical Study in Obesity with BIO101 (20-Hydroxyecdysone) Biophytis SA announced that it is launching a new clinical development program named OBA, with BIO101 (20-hydroxyecdysone) as a potential treatment for obesity in combination with GLP-1 receptor agonists. Obesity treatment can lead to loss of muscle mass and function, notably as a consequence of dieting when combined with the recently introduced GLP-1 receptor agonists. Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs are very effective drugs that lead to significant weight loss. Up to 40% of the total weight loss comes from muscle, which is a problem as muscle tissue's role is central in controlling metabolism, on top of its motor function. Promising results already obtained in obesity: BIO101 (20-hydroxyecdysone) is the first oral daily MAS receptor activator and has demonstrated metabolic effects on muscle and fat tissues in preclinical studies in obesity. These benefical effects of BIO101 (20-hydroxyecdysone) may translate into improved mobility and muscle strength in obese sarcopenic patients, as suggested in the SARA-INT phase 2 study. Furthermore, the 20-hydroxyecdysone molecule was already tested in obese patients during hypocaloric dieting in the Quinolia study, showing promising effects on muscle strength and fat mass loss. BIO101's (20-hydroxyecdysone) potential in the treatment of obesity in combination with GLP-1RAs to counteract the undesirable effects on muscle wasting associated with drastic weight-loss was highlighted in Nature Biotechnology ("After obesity drugs' success, companies rush to preserve skeletal muscle") on March 05, 2024. An accelerated clinical development with results expected in 2025: The OBA Phase 2 clinical study is expected to start mid 2024, upon regulatory approvals, with first patients expected to be treated in the second half of 2024. BIO101 (20-hydroxyecdysone) will be evaluated in obese patients treated with GLP-1 RAs, and following hypocaloric dieting. The Company expects the first results of the efficacy of drug candidate to be available in 2025. Further information on the OBA program and the clinical study is expected to be provided through the coming weeks. 공시 • Feb 15
Biophytis S.A., Annual General Meeting, Mar 18, 2024 Biophytis S.A., Annual General Meeting, Mar 18, 2024. 공시 • Jan 06
Biophytis S.A. Announces the Publication of the Results of its COVA Phase 2-3 Study in eClinicalMedicine, Part of The Lancet Biophytis S.A. announced the publication of an article on the results of its COVA phase 2-3 clinical trial in the treatment of respiratory symptoms in severe forms of COVID-19 in eClinicalMedicine, a medical journal part of the prestigious scientific review The Lancet. This publication is an endorsement of the strength of Biophytis' clinical research and the value of its drug candidate Sarconeos (BIO101) in the treatement of severe forms of COVID-19. Therapeutic advances are still needed in this pathology, as more than 230,000 patients will still have died of the virus worldwide in 2023, out of a total of nearly 7 million since the start of the pandemic. As a reminder, the objective of the COVA Phase 2-3 study (ClinicalTrials.gov, NCT04472728) was to investigate the efficacy and safety of Sarconeos (BIO101), 350 mg BID in hospitalized COVID-19 patients with hypoxemia, at risk of respiratory failure and death. The proportion and time of onset of these adverse events were studied for 28 days, with mortality and safety monitored for more than 90 days. The main result was that in the study population (233 patients; 126 Sarconeos (BIO101) and 107 placebo), respiratory failure or early death by day 28, the primary end-point, was 11.4% lower in the Sarconeos (BIO101) (13.5%) than in the placebo (24.3%) group, (p = 0.0426). Sarconeos (BIO101) significantly reduced the risk of death or respiratory failure by 44%, supporting its use in adults hospitalized with severe respiratory symptoms due to COVID-19. To follow this publication, Biophytis will host two press conferences in France and the United States on 17 January 2024, alongside experts from the scientific and medical communities, to reiterate the potential and clinical benefits of Sarconeos (BIO101) in severe forms of COVID-19, and provide further details on the Group's strategic choice to explore the compound's potential in the treatment of other respiratory viral infections such as influenza. 공시 • Dec 07
Biophytis S.A. and the University of Li Ge Explore the Potential of Sarconeos (BIO101) in the Treatment of Viral Respiratory Diseases Biophytis SA announced the signing of a new partnership with the University of Li ge to carry out a range of preclinical research projects, particularly in the treatment of respiratory failure caused by the flu virus Influenza. Under this partnership, the University's animal pathology research laboratory, headed by Professor Daniel Desmecht, will conduct a series of experiments aimed at establishing the therapeutic potential of Sarconeos (BIO101) in an experimental murine model of infection by an Influenza A virus, which could cause respiratory failure and death in the elderlies. This research is a continuation of the collaboration begun in 2020, which established proof of efficacy on respiratory function and the original mode of action of Sarconeos (BIO101) in an animal model of COVID-19, now confirmed by the clinical data from the Phase 2-3 COVA study. 공시 • Nov 29
Biophytis S.A. Appoints Yann Meunier and Bernard L vy to its Scientific Advisory Board Biophytis SA announced the appointment of Dr. Yann Meunier and Professor Bernard L vy to its Scientific Advisory Board. Yann Meunier is a US-based healthcare professional, currently Professor and Director of the International Institute of Medicine and Science Inc. (IIMS), where he leads the development and implementation of innovative educational programmes and research projects in global health and related fields. He is also a consultant and health expert with HealthConnect International LLC. Over the course of his career, he has worked with leading organizations such as Stanford Hospital & Clinics, Stanford University School of Medicine, George Washington University and Universit Paris VI. He has published widely in the international medical literature and, as an investigator, has led and participated in clinical trials for new treatments for HIV/AIDS, tropical andinfectious diseases, and cardiovascular and respiratory diseases. Bernard L vy is Professor Emeritus of Physiology and a senior member of PARCC (Inserm U970). He headed the physiology and functional investigations department and the Inserm cardiovascular research centre at Lariboisi re Hospital in Paris. After studying medicine, he focused on physiology, fluid mechanics, cardiology and vascular medicine. His work focuses on vascular biology in ageing, hypertension, diabetes and Alzheimer's disease, and he has particularly studied the functions of the renin-angiotensin system in these different diseases. 공시 • Oct 28
Biophytis Receives Notice of Delisting from Nasdaq and Announces It Will Request A Hearing Before the Nasdaq Hearings Panel Biophytis S.A. announced that it has received a notice of delisting from Nasdaq. The staff of the Listing Qualifications Department has determined that the Company's securities have not regained compliance with the minimum $2,500,000 stockholders' equity requirement for continued listing on The Nasdaq Capital Market, as set in Listing Rule 5550(b). The Notice further states that unless the Company timely requests a hearing before a Nasdaq Hearings Panel, the Company's securities would be subject to delisting. Accordingly, the Company intends to timely request a hearing before the Panel. The hearing request will automatically stay any suspension or delisting action pending the hearing. Pursuant to the Nasdaq Listing Rules, the Panel has the discretion to grant the Company an additional extension not to exceed April 23, 2024. At the hearing, the Company will present its plan for regaining and sustaining compliance with the Equity Requirement for continued listing. 공시 • Sep 29
Biophytis S.A. Provides an Update on the Progress of its R&D Projects over the 1St Half of the Year and the Last Few Months OBiophytis S.A. provided an update on the progress of its R&D projects over the 1st half of the year and the last few months. During the first half of 2023, the company achieved key milestones in the development of main drug candidate, Sarconeos (BIO101), with a view to partnerships and market access in 2024, despite a particularly challenging financial environment. Pursuant to an accelerated development over the last two years, the company obtained positive results from phase 2-3 COVA. Biophytis is one of the few European companies to have obtained proof of efficacy in patients with severe forms of COVID-19. The company is pursuing the pharmaceutical and regulatory development of Sarconeos (BIO101), and are currently in discussions with European and American regulatory agencies to define the conditions for market access. In addition, due to the encouraging results obtained with the SARA-INT phase 2b study, Biophytis has received authorizations from the US and Belgian agencies to start the clinical SARA-31 study, which will be the first phase 3 study ever launched in sarcopenia. Finally, the Company has strengthened its management team over the last few months, notably in pharmaceutical operations, finance and business development, in order to forge strategic partnerships for the development of Sarconeos (BIO101).With the progress made in its pipeline, Biophytis is confirming its pioneering position in the development of treatments for age-related diseases, generating a strong medical need that is set to grow very rapidly in the years ahead. Second half of 2023: discussions with the European Agency for the Evaluation of Medicinal Products (EMA) and the US Food and Drug Administration (FDA) in the context of scientific advice to clarify the additional information to be submitted as part of marketing authorization applications, in particular the protocol for a confirmatory phase 3 clinical study. Biophytis will also present to the agencies the possibility of extending the scope of its indication to respiratory viral diseases other than COVID-19, in particular influenza. Second half of 2023: request for reactivation of the authorization for the early access program in Brazil, granted in early 2022. First half of 2024: resubmission to the HAS of an application for authorization of an early access program in France. SARA program: Following the authorizations received from the Belgian and US agencies to conduct a phase 3 trial, the Company will actively pursue its search for partners with a view to initiating the trial in 2024, in collaboration with global or regional pharmaceutical companies under a licensing agreement. MYODA program: first half of 2024: start of a phase 1-2 trial. MACA program: Continuing pre-clinical development work on Macuneos (BIO201) and its back-up BIO203 and preparing for clinical development in dry AMD. 공시 • Sep 21
Biophytis SA Provides Update on its Early Access Programs for Sarconeos (BIO101) in Treatment of Severe Forms of COVID-19 Biophytis SA announced that it has received a response from the French National Authority for Health (HAS) to its request for Early Access Authorization in France for patients suffering from severe forms of COVID-19 and provides an update on its strategy in other countries. After examining the Early Access Authorization request file submitted at the end of May 2023, HAS considered that the Company had not provided sufficient data allowing it to evaluate precisely the benefit vs. risk ratio and to authorize the treatment of patients with severe forms of COVID-19, despite the statistically significant results of the phase 2-3 COVA study. The Company must therefore complete the file by providing in particular certain results of pharmaceutical studies, in progress with its industrial partner Sequens, as well as certain additional data and scientific arguments relating to its phase 2-3 COVA study. On the basis of these various elements, it is planned to resubmit the application to the HAS in the first quarter of 2024, with pharmaceutical partner Intsel Chimos, depending on the progress made in the development plan. At the same time, Biophytis is taking steps in Brazil to confirm the early access authorization obtained in early 2022 that was interrupted pending publication of the full results of the COVA study. This new authorization is expected by the end of the year. Finally, the Company is exploring the possibilities of launching early access programs in other key countries in Europe, in order to best respond to the medical need in a pathology that has become endemic. 공시 • Sep 20
Biophytis SA Receives Response from the French National Authority for Health to Request for Early Access Authorization in France for Patients Suffering from Severe Forms of COVID-19 Biophytis SA announced that it has received a response from the French National Authority for Health (HAS) to its request for Early Access Authorization in France for patients suffering from severe forms of COVID-19 and provides an update on its strategy in other countries. After examining the Early Access Authorization request file submitted at the end of May 2023, has considered that the Company had not provided sufficient data allowing it to evaluate precisely the benefit vs. risk ratio and to authorize the treatment of patients with severe forms of COVID- 19, despite the statistically significant results of the phase 2-3 COVA study. The Company must therefore complete the file by providing in particular certain results of pharmaceutical studies, in progress with its industrial partner Sequens, as well as certain additional data and scientific arguments relating to its phase 2-3 COVA Study. On the basis of these various elements, it is planned to resubmit the application to the HAS in the first quarter of 2024, with pharmaceutical partner Intsel Chimos, depending on the progress made in the development plan. At the same time, Biophytis is taking steps in Brazil to confirm the early access authorization obtained in early 2022 that was interrupted pending publication of the full results of the COVA study. This new authorization is expected by the end of the year. Finally, the Company is exploring the possibilities of launching early access programs in other key countries in Europe, in order to best respond to the medical need in a pathology that has become endemic. 공시 • Sep 14
Biophytis S.A. Announces Executive Changes Biophytis S.A. announced the strengthening of its management team with the appointment of Edouard Bieth as Chief Business Officer and member of the Executive Committee. A recognized industry leader with over 18 years' experience in the pharmaceutical industry, Edouard Bieth has held a number of senior management positions and has developed strong expertise in market access and sales and marketing strategy, both globally and locally. He will be a member of the Executive Committee and will report directly to Stanislas Veillet, Chairman and CEO of Biophytis. Most recently Edouard spent 6 years as General Manager France & BeNeLux of Tillotts Pharma's commercial subsidiary. During his career, Edouard has also worked for various industry players, including AstraZeneca, Servier and Menarini. He has a Master's degree in biology and pharmacology of ageing and trained in sales and marketing strategy at HEC Paris and in finance at the London Business School. Biophytis has also appointed Claudia Ferreira as Medical Director, reporting to Rob Van Manen, Chief Medical Officer, to strengthen links with the medical community and unite experts around development programmes, which address major unmet medical needs in severe age-related diseases. 공시 • Sep 12
Biophytis Obtains Fda Authorization to Initiate the Sara-31 Phase 3 Study in Sarcopenia Biophytis SA aimed at slowing the degenerative processes associated with aging improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, announced that it has received FDA (Food and Drug Administration) authorization to launch its SARA-31 study in the US, the first ever phase 3 study in sarcopenia. This authorization complements the positive opinion obtained this summer from the Belgian authorities to conduct the SARA-31 phase 3 study. The company still needs to obtain authorizations from ethics committees in the countries before launching this study. The effective start of the study is scheduled for 2024, and will depend on the conclusion of partnership agreements and the Company's financial resources. The aim of phase 3 is to evaluate the efficacy and safety of Sarconeos (BIO101) in the treatment of sarcopenic patients at risk of motor disability. Around 900 patients aged over 65 will be included with sarcopenia (Short Physical Performance Battery (SPPB) score between 3 and 7), with low walking speed (4-meter walking speed ? 0.8 m/s) and low hand grip strength (HGS < 20kg for women and < 35.5 kg for men). They will be treated for a minimum of 12 months and a maximum of 36 months, receiving either placebo or 350 mg of Sarconeos (BIO101) twice daily. The primary efficacy parameter will be the time to onset of Major Mobility Disability (MMD), measured by the inability to walk 400m in less than 15 minutes without sitting, help from another person or use of a walker. This main measure will be supplemented by the following secondary effectiveness measures: walking speed (4-m walking speed from the SPPB test), hand grip strength and patient-reported quality of life (Patient Reported Outcome SarQol, a questionnaire specifically developed for sarcopenia). Roger A. Fielding, PhD, sarcopenia expert and laboratory director at Tufts University, Boston, will be the principal investigator of the SARA-31 study. He is continuing his contribution to the Sarconeos (BIO101) clinical development program in this indication. 공시 • Aug 17
Biophytis SA Announces Next Regulatory Steps in Europe and the United States for its COVA Project Biophytis SA announced that it has received feedback from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) enabling it to plan the next regulatory steps for its COVA project dedicated to the development of Sarconeos (BIO101) for severe forms of Covid-19. After filing requests for pre-submission meetings with both agencies in recent weeks, the company will now request a scientific advice meeting in Europe and a Type B meeting in the United States. The purpose of these meetings will be to gather recommendations from the EMA and the FDA to fine-tune COVA's development plan prior to marketing approval. These discussions will enable Biophytis to present the available data (preclinical, clinical, product and industrialization) and specify the additional information to be provided in the context of marketing authorization applications, in particularly the design of a confirmatory phase 3 clinical study. Biophytis will also present the agencies with the possibility of extending the scope of its indication to viral respiratory pathologies other than Covid-19, notably influenza, based on its non-specific mechanism of action. This extension would significantly increase the number of patients eligible for treatment and optimize the commercial potential of Sarconeos (BIO101). 공시 • Aug 09
Biophytis SA Receives Positive Opinion for its SARA-31 Phase 3 Study in Sarcopenia in Europe Biophytis SA announced that it has received a positive opinion from Belgian authorities to conduct its SARA-31 program, which will be the first phase 3 study ever launched in sarcopenia. The launch of the Phase 3 program follows the promising results obtained in the SARA-INT Phase 2b study, and the scientific advice given in 2022 by the EMA (European Medicine Agency), which helped define the conditions for starting such a study in Europe, specifying the Phase 3 protocol. Final authorization depends on a positive opinion from the Ethics Committee in Belgium. A similar application has been filed with the FDA (Food and Drug Administration) to start this study in the United States, with a response expected in the coming weeks. Further authorizations may be requested in other countries, depending on the needs of the study. About SARA-31 The aim of phase 3 is to evaluate the efficiency and safety of Sarconeos (BIO101) in the treatment of sarcopenic patients at risk of motor disability. Around 900 patients aged over 65 with severe sarcopenia (3 SPPB 7) with low walking speed (4-meter walking speed 0.8 m/s) and low grip strength (HGS < 20kg for women and < 35.5kg for men) will be included. They will be treated for a minimum of 12 months and a maximum of 36 months, receiving either placebo or 350mg of Sarconeos ("BIO101") twice daily. The main criterion will be an assessment of the risk of Major Mobility Disability (MMD), measured by the ability to walk 400m in less than 15 minutes. This main criterion will be supplemented by the following secondary criteria: walking speed (4-m walking speed from the SPPB - Short Physical Performance Battery - test), grip strength (HGS) and patient-reported quality of life (Patient Reported Outcome SarQol, a questionnaire specifically developed for sarcopenia). Roger A. Fielding, PhD, sarcopenia expert and laboratory director at Tufts University, Boston, will be the principal investigator of the SARA-31 study. He is continuing his contribution to the SARA-31 clinical development program in this indication. 공시 • Jul 23
Biophytis S.A. Files for a Pre-Submission Meeting with the FDA for an Emergency Use Authorization of Sarconeos (BIO101) for the Treatment of COVID-19 Biophytis SA announced that it has filed for a pre-submission meeting request with the Food and Drug Administration (FDA) to discuss filing for Emergency Use Authorization (EUA) in the United States for Sarconeos (BIO101) in the treatment of severe forms of COVID-19. This is a further key step in defining the conditions for rapid market access in the United States for SARConeos(BIO101) in thetreatment of severe forms of COVID -19, following the similar process initiated with the European Medicine Agency (EMA) in May, in a context where COVID-19 is still associated with a public health problem in the United States and in Europe. Like influenza, this pathology has become an endemic respiratory infectious disease that can lead to Acute Respiratory Distress Syndrome (ARDS) in elderly, immunocompromised or co-morbid patients. According to the WHO, the medical need remains high, with several thousand deaths per week in the United States and Europe. In this context, the positive clinical results of the phase 2-3 COVA study, with a 44% reduction in the risk of respiratory failure or early death, suggests that Sarconeos (BIo101) could become an important new therapeutic option alongside antiviral or anti-inflammatory treatments. 공시 • Jul 21
Biophytis and Seqens Sign A Partnership to Produce Sarconeos (Bio101) Active Compound Biophytis SA announced the conclusion of a master agreement for the production of the active compound in Sarconeos (BIO101), Biophytis' main drug candidate developed for three indications: severe forms of Covid-19, sarcopenia and Duchenne muscular dystrophy. SEQENS will produce the active ingredient in Sarconeos (BIO101) in France at its Villeneuve La Garenne plant, near Paris. This historic site was modernized and expanded in 2020 with the opening of a unit to produce high-pot potential active pharmaceutical ingredients (APIs). This partnership is part of a political context in which the relocation of the production of certain active compounds is recognized as essential to national and European health sovereignty. 공시 • Jul 11
Biophytis SA Filed with the FDA for Authorization to Initiate SARA-31 Phase 3 Study in Sarcopenia Biophytis SA announced that it has filed for approval on the Food and Drug Administration (FDA) portal to launch its SARA-31 program in the U.S., the first ever Phase 3 study in sarcopenia. The launch of the Phase 3 program follows promising results from the SARA-INT Phase 2b study and discussions with health authorities in 2022. Based on the results of the previous study and feedback from the U.S. government agency, Biophytis is starting its Phase 3 program by filing the first ever Phase 3 application (SARA-31) in sarcopenia with the FDA. This follows the recent submission to the European Medicines Agency. The objective of the SARA-31 phase 3 study in sarcopenia is to evaluate the efficacy and safety of Sarconeos (BIO101) in the treatment of sarcopenic patients at risk of mobility disability. Approximately 900 patients over 65 years of age with severe sarcopenia (3 = SPPB = 7) with low walking speed (4-m Gait speed = 0.8 m/s) and low grip strength (HGS < 20kg for women and < 35.5 kg for men) will be included. They will be treated for a minimum of 12 months and a maximum of 36 months, receiving either placebo or 350mg of Sarconeos (BIO101) twice daily. The primary endpoint will be the assessment of the risk of Major Mobility Disability (MMD), measured by the ability to walk 400m in less than 15 minutes over time. In addition to this primary endpoint, the following secondary endpoints will be assessed: walking speed (4-m walking speed from the Short Physical Performance Battery (SPPB) test), handgrip strength (HGS) and patient-reported quality of life (Patient Reported Outcome SarQol, a questionnaire developed specifically for sarcopenia). Biophytis expects a response from the regulatory authorities during the third quarter of 2023, which would enable Biophytis to initiate the study in the United States. The principal investigator will be Roger A. Fielding, PhD, who heads the Nutrition, Physiology, Exercise and Sarcopenia (NEPS) Laboratory at Tufts University in Boston. 공시 • Jun 20
Biophytis SA Reports Clinical Results for Sarconeos (BIO101) in Sarcopenia Treatment at the 16th SCWD International Congress Biophytis SA announced that it is taking part in the 16th SCWD (Society on Sarcopenia, Cachexia & Wasting disorders) international congress, a event bringing together experts from all over the world to share thoughts, research and innovations on sarcopenia, Cachexia and wasting disorders. Biophytis has given an oral presentation entitled "BIOPHYTIS BIO101 - a candidate treatment for muscle diseases" on the development of Sarconeos (BIO101) for the treatment of sarcopenia. It was made by Cendrine Tourette, PhD in Neuroscience and Director of translational and clinical research projects on neuromuscular diseases at Biophytis. Ms. Tourette also took part in a round table discussion with top-notch experts on new trials and recent results in the treatment of sarcopenia and cachexia. Building on the promising results of Phase 2 of SARA-INT, Biophytis is currently in advanced discussions with the European (EMA) and American (FDA) regulatory authorities. EEMA and FDA approvals for the start of Phase 3 of the SARA program are expected in the second half of 2023. Sarconeos (BIo101) would therefore be the first and only drug candidate to enter Phase 3 for the treatment of sarcopenia. 공시 • May 19
Biophytis S.A., Annual General Meeting, Jun 16, 2023 Biophytis S.A., Annual General Meeting, Jun 16, 2023. 공시 • May 12
Biophytis S.A. has completed a Follow-on Equity Offering in the amount of €2.302535 million. Biophytis S.A. has completed a Follow-on Equity Offering in the amount of €2.302535 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 18,562,859
Price\Range: €0.0222
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 85,154,952
Price\Range: €0.0222 공시 • May 10
Biophytis SA Files for Pre-Submission Meeting Request with the European Medicine Agency (EMA) to Discuss Filing for Conditional Marketing Authorisation (CMA) in Europe Biophytis SA announced that it has filed for a pre-submission meeting request with the European Medicine Agency (EMA) to discuss filing for conditional Marketing Authorisation (cMA) in Europe for Sarconeos (BIO101) in the treatment of severe form of COVID-19. This is the first step in the regulatory process that the company is undertaking to define the eligibility and conditions for conditional Marketing Authorisation application in Europe for SarconeOS (BIO101) in The treatment of severe form of COVID-19. A request for a pre-submission meeting with the Food and Drug Administration (FDA) for an Emergency Use Authorisation (EUA) application in the US is expected to be filed later this quarter. 공시 • Feb 02
Biophytis Announces Positive Final Results of the Phase 2-3 COVA Study with Sarconeos (BIO101) in Severe COVID-19 Biophytis SA released the final results from its phase 2-3 COVA clinical study evaluating Sarconeos (BIO101) in the treatment of COVID-19-related respiratory failure. Biophytis announced final results following the reintegration of data from 54 patients, among 233 patients treated, that were missing in the Top Line analysis released on September 7, 2022. The final analysis demonstrates that COVA study met the primary endpoint, with a 44% statistically significant reduction (p = 0.043) in the risk of respiratory failure or early death in hospitalized patients with severe COVID-19, in line with positive Post-Hoc analysis released on November 3, 2022. Biophytis is nowinitiating key regulatory activities to give access to Sarconeos (BIO101) to hospitalized patients with severe COVID-19 at risk of respiratory failure and death in 2023. The strategy to give access to Sarconeos (BIO101) as quickly as possible is to file for Early Access Programs (EAP) in France and Brazil, while filing for conditional Marketing Authorisation (CMA) in Europe and Emergency Use Authorization (EUA) in the USA. An EAP has already been approved in 2022 in Brazil to treat COVID-19 patients at critical stage in Intensice Care Units (ICU) and the request to lift the hold given completion of the study and positive results is pending. The filing of the request for starting the EAP program in France is being prepared and will be made in First Quarter 2023 with the objective to be granted approval in Second Quarter 2023. Requests for pre-submission meetings regarding conditional Marketing Authorisation in Europe and Emergency Use Authorization in the USA are under preparation and will be sent in First Quarter 2023, targeting an approval later in 2023, depending on feedback from authorities. Biophytis will present the results in detail at the American Thoracic Society conference in Washington, DC, USA in May 2023 and at the European Respiratory Society Lung Science meeting in Estoril, Portugal, in March 2023. The objective of the study was to investigate the efficacy and safety of Sarconeos (BIO101), 350 mg BID in hospitalized COVID-19 patients with hypoxemia, at risk of respiratory failure requiring high flow oxygen or mechanical ventilation, and death. The proportion of patients and time to respiratory failure or early death were studied at 28 days in the primary analysis, corresponding to the maximum treatment period, with follow-up of mortality and safety for at least 90 days. The 233 treated patients (Intent To Treat, ITT population) were 63 years old on average, 64% of the patients were male, recruited in 37 centers in Europe, the US and Brazil between Third Quarter 2020 and First Quarter 2022, infected with the main SARS-Cov-2 variants. The trial ended early before reaching the 310 patients originally planned, due to stalled recruitment. The sub-population of patients without major protocol deviations (Per Protocol, PP sub-population) included 180 patients with similar baseline demographics and disease characteristics as the ITT population. The study met its pre-defined primary endpoint demonstrating a statistically significant difference between Sarconeos (BIO101) and placebo in the proportion of patients with respiratory failure or early death at day 28, representing a relative reduction of risk of 44% (p=0.043, Cochran-Mantel-Haenszel test). Moreover, the analysis of time to respiratory failure or early death had shown significant differences over 28 days in the Kaplan Meier curves for Sarconeos (BIO101) versus placebo (p=0.022). The pre-specified analysis of time to death over the complete follow-up period over 90 days showed that mortality rate with Sarconeos (BIO101) was reduced compared to placebo in the ITT population (p=0.083) and in the PP population (p=0.038). Post hoc Kaplan-Meier analysis released on November 3, 2022 confirmed the effect of Sarconeos (BIO101) on the primary endpoint and on mortality at day 90. 공시 • Jan 20
Biophytis S.A. Judgment of the Paris Court of Appeal of 17 January 2023 in the Case Between Biophytis and Negma Group Ltd Biophytis S.A. announces that on the 17th of January 2023 the Paris Court of Appeal rendered a decision in the case between Biophytis and Negma Group Ltd. on the subject of the ORNANEBSA agreement concluded on 21st August 2019. The Paris Court of Appeal has: confirmed the judgment of the Paris Commercial Court of March 16, 2021; ordered Biophytis to pay Negma EUR 75,000 pursuant to Article 700 of the French Code of Civil Procedure as well as costs. Biophytis specifies that it has already performed, in 2021, the entirety of the Judgment. The judgment of the Paris Court of Appeal of January 17, 2023 has not yet been served. Biophytis reserves the right to appeal against it before the French Supreme Court (Cour de Cassation). 공시 • Jan 13
Biophytis to Take Appropriate Measures After Receiving Nasdaq Deficiency Notice Biophytis S.A. received a deficiency notice from The Nasdaq Stock Market Inc. ("Nasdaq") stating that the Company has not filed its financial information for the six-month period ended June 30, 2022 on a Form 6-K (the "Filing") and as a result the Company no longer complies with Nasdaq's listing rules for continued listing set forth in the Listing Rule 5250(c)(2). Nasdaq has informed the Company that it has 60 calendar days or until March 6, 2023 to submit a plan (the "Plan") as definitive as possible to regain compliance with the Nasdaq's continued listing requirements. If Nasdaq accepts the Company's Plan to regain compliance in that respect, Nasdaq can grant an exception of up to 180 calendar days from the prescribed Filing due date or until June 28, 2023 to regain compliance. In determining whether to accept the Company's Plan, Nasdaq will consider such things as the likelihood that the Filing and any subsequent periodic filings can be made within the 180-day period, the Company's past compliance history, the reasons for the late filing, other corporate events that may occur within the Nasdaq review period, the Company's overall financial condition and its public disclosures. The Company is currently working on the Plan to regain compliance with respect to the Listing Rule 5250(c)(2) to meet the requirements for continued listing on the Nasdaq Capital Market. It intends to submit such Plan to Nasdaq as soon as practicable prior to March 6, 2023.