Ankündigung • May 02
Arch Biopartners Inc Begins Patient Recruitment In Phase II Trial Of LSALT Peptide Targeting Cardiac Surgery-Associated Acute Kidney Injury Arch Biopartners Inc. announced that Royal Columbian Hospital (RCH) has begun patient recruitment in the Company’s ongoing Phase II trial evaluating LSALT peptide as a new drug to prevent acute kidney injury in patients undergoing on-pump cardiac surgery. Royal Columbian Hospital, located in New Westminster and part of Fraser Health, is the ninth site to be activated globally for the study and the fourth site to recruit patients in Canada. Patient recruitment into the trial is ongoing at Toronto General Hospital, part of University Health Network, St. Michael’s Hospital, part of Unity Health Toronto, and the University of Calgary, Cumming School of Medicine. Arch continues to evaluate additional sites to support enrollment in the CS-AKI Phase II trial. The Company is in feasibility discussions with cardiac surgery centres in Canada and the United States, including three prospective sites in the United States and one additional site in Ontario (through Clinical Trials Ontario). Cardiac surgery-associated acute kidney injury is a common complication following on-pump (heart-lung machine) cardiac surgery and can lead to longer hospital stays and worse outcomes. The trial is designed to evaluate whether LSALT peptide can reduce the rate of AKI in this setting. The CS-AKI Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide with a recruitment target of 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with acute kidney injury (AKI) in each treatment group within seven days following on-pump cardiac surgery, as defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. The Company has also announced that its Board of Directors has granted a total of 150,000 stock options to a new director pursuant to the Company’s stock option plan and the requirements of the TSX Venture Exchange (TSXV). Each of these stock options is exercisable into one common share of the Company at a price of $1.05 per share for a period of 10 years, effective April 29, 2026, and will be subject to all necessary regulatory approvals. Arch Biopartners Inc. is a therapeutic biotech company developing novel drugs for acute kidney injury (AKI) and chronic kidney disease (CKD). The Company is advancing an integrated program that includes new treatments targeting inflammation- and toxin-related kidney injury. Arch’s development pipeline includes: LSALT peptide: in a Phase II trial targeting cardiac surgery-associated AKI. Cilastatin: a repurposed drug in a Phase II trial targeting toxin-induced AKI. CKD Platform: next-generation therapeutics targeting chronic kidney disease. These assets represent distinct, mechanism-based approaches to treating and preventing common causes of kidney damage. Together, they target unmet needs in kidney care across both chronic and acute indications, affecting more than 800 million people worldwide. Both lead programs are currently enrolling patients at Canadian clinical sites, with additional North American sites in development. Ankündigung • Apr 02
Arch Biopartners Inc. announced that it has received CAD 0.6 million in funding On April 2, 2026, Arch Biopartners Inc. closed the transaction. The offering involved the issuance of 81,667 Common Shares to an officer of the Company and therefore a related party transaction. Ankündigung • Mar 31
Arch Biopartners Inc. announced that it expects to receive CAD 0.6 million in funding Arch Biopartners Inc. announced a non-brokered private placement to issue 1,000,000 common shares at an issue price of CAD 0.60 for gross proceeds of CAD 600,000 on March 30, 2026. The offering is expected to close on April 2, 2026 and is subject to certain conditions including, but not limited to, the receipt of applicable regulatory approvals, including conditional and final approval from the TSX Venture Exchange, as well as the satisfaction of customary closing conditions. All common shares issued in connection with the offering will be subject to a hold period of four months and one day from the closing date. There are no finders’ fees to be paid in connection with the offering. Ankündigung • Mar 25
Arch Biopartners Inc and Fraser Health Authority Enter into Clinical Trial Agreement for Phase II Cardiac Surgery-Associated AKI Trial Arch Biopartners Inc. announced that the Fraser Health Authority has entered into a Clinical Trial Agreement with Arch to enable the Royal Columbian Hospital to begin preparing for the recruitment phase in Arch’s ongoing Phase II trial evaluating LSALT peptide for the prevention and treatment of cardiac surgery-associated acute kidney injury. With the Clinical Trial Application completed, Royal Columbian Hospital has now received final Research Ethics Board and operational approvals, including the final letter of authorization from Fraser Health. Royal Columbian Hospital will be the ninth site activated globally in the study and will be the fourth site to recruit patients in Canada. Toronto General Hospital, part of University Health Network, St. Michael’s Hospital, part of Unity Health Toronto, and the University of Calgary, Cumming School of Medicine, continue to actively enroll new patients into the trial. The Company is currently progressing feasibility and start-up discussions with additional cardiac surgery centres in Canada and the United States. Arch’s development pipeline includes LSALT peptide in a Phase II trial targeting cardiac surgery-associated AKI, Cilastatin a repurposed drug in a Phase II trial targeting toxin-induced AKI, and CKD Platform next-generation therapeutics targeting chronic kidney disease. These assets represent distinct, mechanism-based approaches to treating and preventing common causes of kidney damage. Both lead programs are currently enrolling patients at Canadian clinical sites, with additional North American sites in development. The Company has 66,933,289 common shares outstanding. Ankündigung • Jan 27
Arch Biopartners Inc., Annual General Meeting, Mar 30, 2026 Arch Biopartners Inc., Annual General Meeting, Mar 30, 2026. Ankündigung • Jan 16
Arch Biopartners Inc. Announces Appointment of Patrick Vink as Chairman of the Board and Retirement of Claude Allary from the Board of Directors Arch Biopartners Inc. announced the appointment of Dr. Patrick Vink as Chairman of the Company’s Board of Directors, effective January 15, 2026. Dr. Vink, M.D., M.B.A., has been an advisor to the pharmaceutical industry since 2015 and has served as a non-executive board member or chair of several public and private companies in North America and Europe. He has overseen or supported several transactions in these roles, including Bruker Corporation’s majority-ownership investment in Biognosys AG in 2023, and Chiesi Farmaceutici’s acquisition of Amryt Pharma later the same year. Dr. Vink previously served as Executive Vice President and Chief Operating Officer of Cubist Pharmaceuticals Inc., overseeing global commercial and technical operations until its $9.5 billion acquisition by Merck in 2015. Prior to Cubist, he was Senior Vice President, Global Head of Hospital Business and Biologics for Mylan Inc. (now Viatris Inc.). Earlier in his career, he held senior roles at Novartis Sandoz, Biogen, and Sanofi-Synthelabo. He served as a director of Arch Biopartners from December 2016 until December 2019, and continued to support the Company as a Strategic Advisor thereafter. Dr. Vink’s appointment follows the retirement of Claude Allary from the Board of Directors. Mr. Allary has served as a director since 2014 and helped support Arch evolve into becoming a leading kidney therapeutics company, with two lead drug candidates currently in Phase II trials. Ankündigung • Dec 17
Arch Biopartners Inc. Announces Ethics Approval for St. Michael's Hospital to Participate in the Phase II Cardiac Surgery-Associated AKI Trial for LSALT Peptide Arch Biopartners Inc. announced that the University Health Network Research Ethics Board has granted ethics approval for St. Michael's Hospital, a site of Unity Health Toronto, to participate in Arch's ongoing Phase II trial evaluating LSALT peptide for the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). With the UHN REB approval, issued through the Clinical Trials Ontario (CTO) Stream system, St. Michael's Hospital in Toronto, Ontario will now proceed to complete operational approvals, training, and site initiation before commencing patient enrollment. St. Michael's Hospital will be the ninth site activated globally and the fourth site within one of Canada's leading academic hospital networks. Incidence of CS-AKI: Acute kidney injury (AKI) is a frequent complication following cardiac surgery, especially in procedures that use a heart-lung machine. Clinical studies report that up to 30% of patients undergoing on-pump cardiac surgery develop CS-AKI, a condition that increases the risk of serious complications, longer hospital stays, and increased mortality. With no approved therapies available, CS-AKI remains an area of significant unmet medical need. LSALT peptide offers a potential first-in-class therapeutic approach to prevent inflammation injury in patients at high risk of developing AKI. Ankündigung • Nov 20
Arch Biopartners Inc. announced that it has received CAD 0.6 million in funding On November 19, 2025, Arch Biopartners Inc. closed the transaction. The Offering involved the issuance of 480,923 Common Shares to an officer of the Company There were no finders’ fees paid in connection with the Offering.. Ankündigung • Nov 10
Arch Biopartners Inc. announced that it expects to receive CAD 0.5 million in funding Arch Biopartners Inc. announced a non brokered private placement to issue 480,769 common shares priced at CAD 1.04 per common share for gross proceeds of CAD 499,999.76 on November 10, 2025. The Offering will close on November 12, 2025 and is subject to certain conditions including, but not limited to, the receipt of applicable regulatory approvals, including conditional and final approval from the TSX Venture Exchange, as well as the satisfaction of customary closing conditions. All Common Shares issued in connection with the Offering will be subject to a hold period of four months and one day from the closing date. There are no finders’ fees to be paid in connection with the Offering. Ankündigung • Nov 07
Arch Biopartners Expands Phase II Cardiac Surgery-Associated AKI Trial to Include Royal Columbian Hospital in British Columbia Arch Biopartners Inc. announced that the Fraser Health Research Ethics Board has granted approval for the Royal Columbian Hospital (RCH) to participate in Arch's ongoing Phase II trial evaluating LSALT peptide for the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). With this ethics approval in place, the clinical team at RCH in New Westminster, British Columbia, will proceed to complete operational approvals, training, and site initiation prior to commencing patient enrollment. RCH will be the eighth site activated globally in the study and is expected to be the fourth site to recruit patients in Canada. The University Health Network's Toronto General Hospital and the University of Calgary, Cumming School of Medicine, continue to actively enroll new patients into the trial. Unity Health's St. Michael's Hospital has completed its preparatory steps and is awaiting final authorization from Clinical Trials Ontario (CTO) to proceed to site activation and patient enrollment. The Arch team continues to evaluate additional sites in Canada and the U.S. to join the CS-AKI Phase II trial. Ankündigung • Aug 06
Arch Biopartners Inc. Announces First Patient Successfully Dosed at Toronto General Hospital in Phase II Trial of LSALT Peptide Targeting Cardiac Surgery-Associated Acute Kidney Injury Arch Biopartners Inc. announced that the first patient has successfully completed dosing at Toronto General Hospital (TGH), part of the University Health Network (UHN), Canada's largest academic health sciences centre and a global leader in cardiac care and research. The volunteer patient completed five days of dosing as part of the Company's ongoing Phase II trial evaluating LSALT peptide to prevent and treat cardiac surgery-associated acute kidney injury (CS-AKI). TGH joins the University of Calgary Hospital as the second Canadian clinical site to dose patients in this trial. The Company anticipates St. Michael's Hospital (SMH) in Toronto will be the next Canadian site to activate and enroll patients into the study, pending approvals from Clinical Trials Ontario and SMH's ethics board. The Arch team continues to pursue additional clinical sites in Canada and the United States. Patient dosing completed in Turkey has provided a strong safety profile for LSALT peptide. This has given clinical trial teams increased confidence as new sites join the trial to test LSALT peptide's ability to protect kidneys from acute inflammation injury. The CS-AKI Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide with a recruitment target of 240 patients. The start of the Phase II CS-AKI trial and the ongoing dosing of volunteer patients has been mainly supported through non-dilutive funding grants previously disclosed by the Company. The Company will update the study's listing on ClinicalTrials.gov following today's news regarding recruitment at Toronto General Hospital including a revised estimated trial completion date of August 2026. This update reflects the 12 to 18 months required by Canadian sites to complete preparations and obtain provincial and local ethics approvals prior to enrolling patients. The publication also reported notable biomarker findings: patients treated with LSALT peptide showed reductions in a range of inflammatory biomarkers, including a statistically significant decrease in CXCL10, a protein linked to inflammation in the lungs and kidneys. These results support continued clinical development for preventing inflammation injury in the kidneys, lungs and liver. Additional peer-reviewed publications related to LSALT peptide and the DPEP1 pathway are available on the Company's website. Incidence of CS-AKI: Acute kidney injury (AKI) is a frequent complication following cardiac surgery, especially in procedures that use a heart-lung machine. Clinical studies report that up to 30% of patients undergoing on-pump cardiac surgery develop CS-AKI, a condition that increases the risk of serious complications, longer hospital stays, and increased mortality. With no approved therapies available, CS-AKI remains an area of significant unmet medical need. LSALT peptide offers a potential first-in-class therapeutic approach to prevent inflammation injury in this high-risk population. Ankündigung • Jul 22
Arch Biopartners Inc. Announces Start of Patient Recruitment in Phase II PONTIAK Trial Targeting Drug-Toxin-Related Acute Kidney Injury (AKI) Arch Biopartners Inc. announced that the investigator-led Phase II trial titled "Prevention OfephroToxin Induced Acute Kidney Injury with Cilastatin" (PONTIAK) has commenced patient recruitment at its primary clinical sites in Alberta, Canada. The Phase II PONTIAK study aims to evaluate the efficacy of cilastatin in preventing AKI associated with neephrotoxic pharmaceuticals, which include commonly used drugs such as antibiotics, chemotherapy agents, and imaging dyes, some of which are known to cause kidney damage as a side effect. The trial plans to enrol approximately 698 patients in five hospital sites in Alberta. The PONTIAK clinical team, based at the Universities of Calgary and Alberta, secured $1.5 million in funding for the Phase II trial from the Canadian Institutes of Health Research (CIHR), along with $400,000 under the Accelerating Clinical Trials (ACT) initiative aimed at evaluating Canadian biotechnologies using randomized controlled trials. Arch Biopartners recently manufactured the first-ever, stand-alone cilastatin drug product and has provided the drug supply for the trial. While the trial is investigator-led and independently funded, the Company is also evaluating opportunities to support a complementary arm of the study in another jurisdiction, such as the United States under an application to the U.S. Food and Drug Administration. AKI reflects a broad spectrum of clinical presentations, ranging from mild injury to severe injury that may result in permanent and complete loss of renal function. Clinically, the causes of AKI include sepsis,ischemia-reperfusion injury, and various endogenous as well as exogenous (drug) toxins. Cilastatin was approved for use as a fixed combination with imipenem to treat different types of bacterial infections. This fixed combination, approved by the FDA in 1985, is currently marketed under different names, including Primaxin®? (USA, UK, Australia, Italy), Tienam®? (Spain, Belgium), or Zienam®? (Germany). Composition of matter patents for imipenem and cilastatin have expired, and the combination drug is currently in a generic phase. Arch Biopartners owns and has exclusively licensed method-of-use patents to repurpose cilastatin as a new treatment targeting AKI. Ankündigung • Apr 22
Arch Biopartners Inc. Announces Toronto General Hospital Ethics Board Approval to Join the Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury (CS-AKI) Arch Biopartners Inc. announced that the University Health Network (UHN) Research Ethics Board has granted approval for Toronto General Hospital to participate in the Company's ongoing Phase II trial evaluating LSALT peptide for the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). With this ethics approval in place and all training and preparations complete, the clinical team at Toronto General Hospital (TGH) is now cleared to begin patient recruitment. TGH will be the seventh site to be activated globally and the second site to recruit patients in Canada. The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide with a recruitment target of 240 patients. The drug targets the dipeptidase-1 (DPEP1) pathway and has been shown by Arch scientists and their collaborators to prevent IRI to the kidneys in pre-clinical models (video), providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial. Details of their findings were published in the journal, Science Advances, titled "Dipeptidase-1 governs renal inflammation during ischemia reseperfusion injury" by Lau et. al. and can be found along with the latest peer-reviewed publications about DPEP1 and LSALT peptide at the Company's website. Incidence of CS-AKI: Acute kidney injury is a known common complication in patients after coronary artery bypass grafting (CABG) and other cardiac surgeries, including on-pump surgeries, which increase the risk of AKI. The reported prevalence of CS-AKI is up to 30% and is independently associated with an increase in morbidity and mortality. Ankündigung • Mar 16
Arch Biopartners Inc. announced that it has received CAD 0.37325 million in funding On March 14, 2025, Arch Biopartners Inc. closed the transaction. The company issued 145,000 common shares at a price of CAD 1.55 per common share for gross proceeds of CAD 224,750; and 90,000 common shares at a price of CAD 1.65 per common share for gross proceeds of CAD 148,500; for aggregate gross proceeds of CAD 373,250. The offering is subject to certain conditions including, but not limited to, the receipt of applicable regulatory approvals, including final approval from the TSX Venture Exchange. All common shares issued in connection with the offering will be subject to a hold period of four months and one day from the closing date. There are finders’ fees totaling CAD 5,425 to be paid to arm’s-length parties in connection with the offering. Ankündigung • Mar 05
Arch Biopartners Inc. announced that it expects to receive CAD 0.349999 million in funding Arch Biopartners Inc. announced it has arranged a non-brokered private placement offering of 225,806 common shares priced at CAD 1.55 per common share for gross proceeds of CAD 349,999.3 on March 5, 2025. The Offering will close on March 6, 2025 and is subject to certain conditions including, but not limited to, the receipt of applicable regulatory approvals, including conditional and final approval from the TSX Venture Exchange, as well as the satisfaction of customary closing conditions. The Offering will close on March 6, 2025. There are finders’ fees totaling CAD 13,500 to be paid to arm’s length parties in connection with the Offering. All Common Shares issued in connection with the Offering will be subject to a hold period of four months and one day from the closing date Ankündigung • Feb 18
Arch Biopartners Receives No Objection Letter from Health Canada for Investigator-Led Phase II PONTiAK Trial Using Cilastatin to Target Drug-Toxin-Related Acute Kidney Injury Arch Biopartners Inc. announced that the clinical team leading the upcoming investigator-led trial, titled “Prevention Of NephroToxin Induced Acute Kidney Injury with Cilastatin” (PONTiAK), has received a No Objection Letter (NOL) from Health Canada to proceed with the trial. PONTiAK is a 700-patient Phase II trial (revised from 900 patients) evaluating the efficacy of cilastatin in preventing AKI caused by several drugs, including certain antibiotics, chemotherapeutic agents, and radiographic contrast. The PONTiAK clinical team of investigators, based at the Universities of Calgary and Alberta, was awarded $1,500,000 by the Canadian Institutes of Health Research (CIHR) to fund the trial. The team also received $400,000 as part of the Accelerating Clinical Trials (ACT) call for proposals to “Evaluate Canadian Biotechnologies with Randomized Controlled Trials” (October 2023). Funds from both grants will be used by the clinical team to conduct the PONTiAK trial at up to five hospital sites in Alberta. The next steps for the PONTiAK team include the preparation of the hospital sites to conduct the study while working to obtain approvals from the local Research Ethics Board (REB) and Alberta Health Services (AHS) Operational Approval. Arch is acting as a study partner for grant funding opportunities and providing cilastatin drug product to support the trial. While the PONTiAK team continues to prepare the hospital sites and seek approvals from REB and AHS, Arch will evaluate opportunities to sponsor a new arm of the PONTiAK study in another jurisdiction, such as the United States or Europe. Ankündigung • Jan 31
Arch Biopartners Inc. Auditor Raises 'Going Concern' Doubt Arch Biopartners Inc. filed its Annual on Jan 29, 2025 for the period ending Sep 30, 2024. In this report its auditor, Baker Tilly, gave an unqualified opinion expressing doubt that the company can continue as a going concern. Ankündigung • Jan 21
Arch Biopartners Inc., Annual General Meeting, Mar 31, 2025 Arch Biopartners Inc., Annual General Meeting, Mar 31, 2025. Ankündigung • Jan 08
Arch Biopartners Inc. Announces Ontario Research Ethics Board Approval to Proceed with Phase II Trial for LSALT Peptide Targeting Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI) Arch Biopartners Inc. announced that the University Health Network Research Ethics Board, through the Clinical Trials Ontario Streamlined Research Ethics Review System, has granted provincial ethics approval for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). The clinical teams at Toronto General Hospital and St. Michael's Hospital in Toronto are now seeking final internal approvals and completing final preparations to begin patient recruitment in the first quarter of 2025. The trial continues to recruit patients at the University of Calgary Hospital and five clinical sites in Turkey. The CS-AKI Phase II trial is an international, multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide with a recruitment target of 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with acute kidney injury (AKI) within seven days following on-pump (heart-lung machine) cardiac surgery, as defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. Cardiac surgery-associated acute kidney injury (CS-AKI) is often caused by ischemia-reperfusion injury (IRI), which reduces blood flow (ischemia) and oxygen to the kidneys, causing kidney cell damage. When blood flow is restored (reperfusion), inflammation is triggered, exacerbating injury to the kidneys. Currently, no therapeutic treatment is available to prevent acute kidney injury (AKI) of the type commonly experienced by on-pump cardiac surgery patients. In severe cases of AKI, kidney failure occurs, requiring kidney dialysis or kidney transplant for survival. LSALT peptide is Arch's lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. The drug targets the dipeptidase-1 (DPEP1) pathway and has been shown by Arch scientists and their collaborators to prevent IRI to the kidneys in pre-clinical models (video), providing the scientific rationale for Arch to use LSALT peptide in the current CS- AKI trial. Details of their findings were published in the journal Science Advances, titled Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury by Lau et al. and can be found, along with the latest peer-reviewed publications about DPEP1 and LSALT peptide on the Company's website. CS-AKI is a common complication in patients following coronary artery bypass grafting (CABG) and other cardiac surgeries, particularly on-pump procedures, which significantly elevate the risk of AKI. The reported prevalence of CS-AKI is up to 30% and is independently associated with increased morbidity and mortality. Ankündigung • Nov 12
Arch Biopartners Inc. Announces Dosing of First Patient in Canada in the Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury Arch Biopartners Inc. announced that patient recruitment and dosing have begun in Canada for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). The clinical team at the University of Calgary Cumming School of Medicine has started screening patients for the trial and has completed dosing of the first patient recruited into the study in Calgary, Alberta. The University Health Network and Unity Health Toronto are also in the final stage of obtaining ethics and hospital approvals to start patient recruitment into the trial at Toronto General Hospital and St. Michael’s Hospital, respectively. CS-AKI and LSALT peptide: CS-AKI often results from ischemia-reperfusion injury (IRI), which restricts blood flow and oxygen to the kidney (ischemia), leading to kidney cell damage. When blood flow is restored (reperfusion), inflammation is triggered, exacerbating injury to the kidney. There is no therapeutic treatment available in the market that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients. In the worst cases of AKI, the kidneys fail, requiring kidney dialysis or kidney transplant for survival. Incidence of CS-AKI: Acute kidney injury (AKI) is a common complication, with an increased risk in patients undergoing coronary artery bypass grafting (CABG) and other on-pump cardiac surgeries. The reported prevalence of CS-AKI is up to 30%, and it is independently associated with higher morbidity and mortality rates. Ankündigung • Oct 16
Arch Biopartners Inc. announced that it has received CAD 0.450001 million in funding Arch Biopartners Inc. announced a non-brokered private placement offering of 290,323 common shares priced at CAD 1.55 per share for the gross proceeds of CAD 450,000.65 on October 15, 2024. The Offering closed on October 15, 2024 and is subject to certain conditions including, but not limited to, the receipt of applicable regulatory approvals, including final approval of the TSX Venture Exchange, as well as the satisfaction of other customary closing conditions. All Common Shares issued in connection with the Offering will be subject to a hold period of four months and one day from the closing date. There are finders’ fees totaling $2,170 to be paid to an arm’s length party in connection with the Offering. Ankündigung • Sep 11
Arch Biopartners Inc. Announces Alberta Health Services Approval to Proceed with Phase II Trial for LSALT Peptide Targeting Cardiac Surgery-Associated Acute Kidney Injury Arch Biopartners Inc. announced that Alberta Health Services (AHS) has approved the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). The clinical team at the University of Calgary Cumming School of Medicine is now completing final preparations and training to enable the start of patient recruitment in September. University Health Network and Unity Health Toronto are also working on final ethics and hospital approvals to start patient recruitment at Toronto General Hospital and St. Michael's Hospital, respectively. The trial continues to recruit patients at five clinical sites in Turkey. Ankündigung • Aug 02
Arch Biopartners Inc. Announces its Cilastatin Drug Candidate to Participate in Pontiac Phase II Trial Targeting Acute Kidney Injury Caused by Drug Toxins Arch Biopartners Inc. announced that cilastatin, the Company’s second drug candidate for preventing acute kidney injury (AKI), will participate in the upcoming investigator led trial entitled Prevention Of NephroToxin Induced Acute kidney injury with Cilastatin (PONTIAC). PONTIAC is a 900 patient Phase II trial that will evaluate the efficacy of the dipeptidase-1 inhibitor cilastatin for preventing AKI caused by drugs such as antibiotics, chemotherapeutic agents and radiographic contrast. The PONTIAC clinical team of investigators, based out of the Universities of Calgary and Alberta, was awarded $1,500,000 by the Canadian Institutes of Health Research (CIHR) to fund the trial. The clinical team also received $400,000 as part of the Accelerating Clinical Trials (ACT) call for proposals to Evaluate Canadian Biotechnologies with Randomized Controlled Trials (October 2023). Funds from both grants will be used by the clinical team to conduct the PONTIAC trial. The PONTIAC clinical team sponsoring the trial is based in Calgary and is currently preparing to submit a Clinical Trial Application (CTA) to Health Canada to proceed with the trial by the fourth quarter of 2024. Arch is acting as a study partner for grant funding opportunities, providing cilastatin drug product and providing scientific and regulatory advice. Cilastatin is an enzymatic dipeptidase-1 (DPEP1) inhibitor approved by the FDA in 1985 for use as fixed combination with imipenem to treat different types of bacterial infections. Arch has method-of-use patents for repurposing cilastatin as a treatment for acute kidney injury (AKI) in several jurisdictions, including North America and Europe. There is no commercial history of cilastatin as a stand-alone drug product. The drug has a slightly different mechanism of action compared with Arch’s novel drug candidate, LSALT peptide (Metablok) a non-enzymatic DPEP1 inhibitor. Whereas LSALT peptide specifically blocks DPEP1-mediated inflammation in the kidney, lungs and liver, cilastatin has off target-effects that prevent toxin uptake in the kidneys. As such, cilastatin is particularly effective for toxin-related AKI. The PONTIAC trial builds on research published by lead Arch scientists and their colleagues in JCI (The Journal of Clinical Investigation) in 2018, when cilastatin was shown in pre-clinical models to effectively inhibit leukocyte recruitment and drug toxin uptake in the kidney, thereby preventing AKI caused by radiographic contrast. This provides Arch’s drug development program with a second target indication to prevent acute injury to the kidneys. The Company is currently dosing patients with its lead drug candidate, LSALT peptide, in an ongoing, international Phase II study targeting cardiac surgery-associated AKI (CS-AKI). Ankündigung • Jul 31
Arch Biopartners Inc. announced that it has received CAD 0.6 million in funding On July 30, 2024, Arch Biopartners Inc. closed the transaction. The Offering is subject to certain conditions including, but not limited to, the receipt of applicable regulatory approvals, including final approval of the TSX Venture Exchange. All Common Shares issued in connection with the Offering will be subject to a hold period until December 1, 2024. There were no finders’ fees in connection with the Offering. Ankündigung • Jul 30
Arch Biopartners Inc. announced that it expects to receive CAD 0.6 million in funding Arch Biopartners Inc. announced a non-brokered private placement of 400,000 common shares priced at CAD 1.50 per common share for gross proceeds of CAD 600,000 on July 29, 2024. The Offering is expected to close on or before July 31, 2024 and is subject to certain conditions including, but not limited to, the receipt of applicable regulatory approvals, including conditional and final approval of the TSX Venture Exchange, as well as the satisfaction of other customary closing conditions. All Common Shares issued in connection with the Offering will be subject to a hold period of four months and one day from the closing date. There are no finders’ fees in connection with the Offering. Ankündigung • Jun 18
Arch Biopartners Announces University of Calgary Ethics Approval to Proceed with Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury (CS-AKI) Arch Biopartners Inc. announced that the University of Calgary's Conjoint Health Research Ethics Board (CHREB) has approved the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). The clinical team at the University of Calgary Cumming School of Medicine is now able to work with Arch to complete preparation and training to enable the start of patient recruitment in Calgary. This work will be completed while waiting for the expected final approval from Alberta Health Services. The trial continues to have patient recruitment at five clinical sites in Turkey. Since the trial began dosing patients in March, there have been enhancements to the design of the study protocol to help improve the execution of the trial. These changes have since been approved by Health Canada and are pending approval by the Turkish Ministry of Health. The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide with a recruitment target of 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with acute kidney injury (AKI) within seven days following on-pump (heart-lung machine) cardiac surgery, defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. CS-AKI is often caused by ischemia-reperfusion injury (IRI) that reduces blood flow (ischemia) and thus oxygen in the kidney, causing kidney cell damage. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. There is no therapeutic treatment available in the market that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients. In the worst cases of AKI, the kidneys fail, requiring kidney dialysis or kidney transplant for survival. LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. The drug targets the dipeptidase-1 (DPEP1) pathway and has been shown by Arch scientists and their collaborators to prevent IRI to the kidneys in pre-clinical models (video), providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial. Details of their findings were published in the journal, Science Advances, titled “Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury” by Lau et. al. and can be found along with the latest peer-reviewed publications about DPEP1 and LSALT peptide at the Company’s website. Acute kidney injury is a known common complication in patients after coronary artery bypass grafting (CABG) and other cardiac surgeries, including on-pump surgeries which increase the risk of AKI. The reported prevalence of CS-AKI is up to 30% and is independently associated with an increase in morbidity and mortality. Ankündigung • Apr 16
Arch Biopartners Inc. Announces St. Michael's Hospital Joins the Phase II Trial of LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury Arch Biopartners Inc. announced that a research team from St. Michael’s Hospital, a site of Unity Health Toronto, has joined the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. The St. Michael’s Hospital clinical team is awaiting ethics approval prior to beginning enrolment in the trial. The addition of St. Michael’s as the third Canadian clinical site increases the number of trial sites to nine, with six hospitals in Turkey currently recruiting patients. The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide. The recruitment target for the trial is 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with AKI within seven days following on-pump (heart-lung machine) cardiac surgery, defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. CS-AKI is often caused by ischemia-reperfusion injury (IRI) that reduces blood flow (ischemia) and thus oxygen in the kidney, causing kidney cell damage. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. In the worst cases of AKI, kidneys fail, leading to kidney dialysis or kidney transplant. There is no therapeutic treatment available in the market that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients. LSALT peptide targets the dipeptidase-1 (DPEP-1) pathway and has been shown by Arch scientists and their collaborators to prevent IRI to the kidneys in pre-clinical models (video), providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial. Incidence of Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI) Acute kidney injury (AKI) is a known common complication in patients after coronary artery bypass grafting (CABG) and other cardiac surgeries, including on-pump surgeries which increase the risk of AKI. The reported prevalence of CS-AKI is up to 30% and is independently associated with an increase in morbidity and mortality. Ankündigung • Apr 05
Anesthesia Clinical Trials Unit Joins the Phase II Trial of LSALT Peptide Targeting Cardiac Surgery-Associated-Acute Kidney Injury Arch Biopartners Inc. announced that Anesthesia Clinical Trials Unit (ACTU), an academic research organization in the Department of Anesthesia and Pain Management at the University Health Network (UHN), has joined the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company's lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. The UHN clinical team has submitted an application to the local ethics board for permission to participate in the trial. The addition of UHN as the second Canadian hospital site increases the number of trial sites to eight, with six active clinical sites in Turkey. The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide. The recruitment target for the trial is 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with AKI within seven days following on-pump (heart-lung machine) cardiac surgery, defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. CS-AKI is often caused by ischemia-reperfusion injury (IRI) that reduces blood flow (ischemia) and thus oxygen in the kidney, causing kidney cell damage. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. In the worst cases of AKI, kidneys fail, leading to kidney dialysis or kidney transplant. There is no treatment available in the market that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients. LSALT peptide targets the dipeptidase-1 (DPEP-1) pathway and has been shown by Arch scientists and their collaborators to prevent IRI to the kidneys in pre-clinical models (video), providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial. Details of their findings were published in the journal, Science Advances, titled "Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury" by Lau et. al. and can be found along with previous peer-reviewed publications about DPEP-1 and LSALT peptide at the Company's website. Advisory services and a funding contribution from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) announced by the Company in March 2023, will significantly offset the costs of the CS-AKI Phase II trial. Acute kidney injury (AKI) is a known common complication in patients after coronary artery bypass grafting (CABG) and other cardiac surgeries, including on-pump surgeries which increase the risk of AKI. The reported prevalence of CS-AKI is up to 30% and is independently associated with an increase in morbidity and mortality. Ankündigung • Mar 20
Arch Biopartners Clinical Team Publishes Data from Phase II Trial for Lsalt Peptide Targeting Organ Inflammation in Hospitalized Patients Infected with Sars-Cov-2 Arch Biopartners Inc. announced that it has published a peer reviewed paper in the British Medical Journal Open (BMJ Open) detailing the results of the international Phase II human trial for LSALT peptide targeting acute lung and kidney inflammation in hospitalized patients infected with SARS-CoV-2 virus. LSALT peptide is a DPEP-1 inhibitor and the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs, and liver. The paper in BMJ Open describes the clinical highlights, outcomes and biomarker results of the study. The Phase II trial was an international, multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide for the prevention of organ inflammation such as acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) in patients infected with SARS-CoV-2. The exploratory, adaptive trial was initiated in the early stages of the global pandemic to identify clinical signals of efficacy for LSALT peptide in the treatment of acute lung and kidney inflammation. The results of the Phase II trial provided first-ever evidence validating DPEP-1 as a mediator of organ inflammation and therapeutic target in humans. In addition, LSALT peptide was well tolerated with no safety issues related to the drug. New biomarker data for LSALT peptide was disclosed for the first time in the BMJ Open publication. An analysis of serum inflammatory biomarkers was performed from blood samples collected from study participants. Biomarkers analyzed which relate to organ inflammation included cytokines and chemokines such as IL-6, CXCL8, CXCL10, IL-1ß and CCL7. Collectively, a greater proportion of inflammatory biomarkers decreased in patients receiving LSALT peptide compared with placebo. In particular, the reduction of CXCL10 in the LSALT peptide group versus the placebo group was statistically significant at the end of treatment. CXCL10 plays a role in facilitating leukocyte recruitment to various vascular beds including the lungs and kidneys. The reduction of CXCL10 and the other inflammatory biomarkers during LSALT peptide treatment is consistent with LSALT peptide’s mechanism of action as an inhibitor of DPEP-1 mediated leukocyte recruitment to the lungs and kidneys. The new data provides more scientific rationale for Arch to advance LSALT peptide to prevent leukocyte recruitment and organ inflammation for other indications, including a larger Phase II trial targeting cardiac surgery-associated AKI, which recently began recruiting patients. Ankündigung • Mar 16
University of Calgary Joins the Phase II Trial of LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury Arch Biopartners Inc. announced that a research team from the University of Calgary’s Cumming School of Medicine has joined the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. Dr. Gregory’s clinical team has submitted an application to the local Research Ethics Board for permission to participate in the trial. The addition of the first Canadian clinical site increases the number of trial sites to four, with three hospitals in Turkey currently recruiting patients. There are three additional hospital sites in Turkey pending activation into the trial. The Arch Biopartners team is currently working with two other hospital sites in Canada to prepare for their participation in this Phase II trial. The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide. The recruitment target for the trial is 240 patients. The primary objective of the trial is to evaluate the percentage of subjects with AKI within seven days following on-pump (heart-lung machine) cardiac surgery, defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI) and LSALT peptide: CS-AKI is often caused by ischemia-reperfusion injury (IRI) that reduces blood flow (ischemia) and thus oxygen in the kidney, causing kidney cell damage. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. In the worst cases of AKI, kidneys fail, leading to kidney dialysis or kidney transplant. There is no treatment available in the market that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients. LSALT peptide targets the dipeptidase-1 (DPEP-1) pathway and has been shown by Arch scientists and their collaborators to prevent IRI to the kidneys in pre-clinical models (video), providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial. Details of their findings were published in the journal, Science Advances, titled “Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury” by Lau et. al. and can be found along with previous peer-reviewed publications about DPEP-1 and LSALT peptide at the company’s website. Advisory services and a funding contribution from the National Research Council of Canada Industrial Research Assistance Program(NRC-IRAP) announced by the Company in March 2023, will significantly offset the costs of the CS-AKI Phase II trial. Incidence of Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI): Acute kidney injury (AKI) is a known common complication in patients after coronary artery bypass grafting (CABG) and other cardiac surgeries, including on-pump surgeries which increase the risk of AKI. The reported prevalence of CS-AKI is up to 30% and is independently associated with an increase in morbidity and mortality. Ankündigung • Mar 08
Arch Biopartners Inc. Announces Dosing of First Patient in Phase II Trial for LSALT Peptide Targeting Cardiac Surgery-Associated-Acute Kidney Injury Arch Biopartners Inc. announced that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company's lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. There are three hospital sites in Turkey actively screening cardiac surgery patients for this trial.osuyolu Research Hospital and Kocaeli University Research Hospital are located within and near Istanbul respectively. The third site is Erciyes University, Faculty of Medicine Organ Transplant & Dialysis Hospital, and is located in central Turkey. There are three additional hospital sites in Turkey pending activation into the trial. LSALT peptide targets the dipeptidase-1 (DPEP-1) pathway and has been shown by Arch scientists and their collaborators to prevent IRI to the kidneys in pre-clinical models, providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial. Details of their findings were published in a Science Advances publication, titled "Dipeptidase-1 governs renal inflammation during ischemia reperfusion injury" by Lau et.al. and can be found at the following link at the journal's website. Advisory services and a funding contribution from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) announced by the Company in March 2023, will significantly offset the costs of the CS-AKI Phase II trial. Acute kidney injury (AKI) is a known common complication in patients after coronary artery bypass grafting (CABG) and other cardiac surgeries, including on-pump surgeries which increase the risk of AKI. The reported prevalence of CS-AKI is up to 30% and is independently associated with an increase in morbidity and mortality. Ankündigung • Jan 19
Arch Biopartners Inc., Annual General Meeting, Apr 02, 2024 Arch Biopartners Inc., Annual General Meeting, Apr 02, 2024. Ankündigung • Jan 11
Arch Biopartners Inc. Receives Health Canada Approval to Conduct Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury Arch Biopartners Inc. announced that it has received a No Objection Letter from Health Canada to conduct a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. The Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide. The primary objective of the trial is to evaluate the percentage of subjects with AKI within 7 days following on-pump (heart-lung machine) cardiac surgery, defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria. There is no treatment available in the market that prevents acute kidney injury of the type commonly experienced by on-pump cardiac surgery patients. The No Objection Letter from Health Canada follows prior approvals from the U.S. Food and Drug Administration and the Turkish Ministry of Health to proceed with the Phase II CS-AKI trial in their respective jurisdictions. Patient enrollment is expected to commence in Turkey in February 2024, followed by recruitment in Canada at select clinical sites in Alberta and/or Ontario. Cardiac Surgery-Associated Acute Kidney Injury (CS-AKI) and LSALT peptide: CS-AKI is often caused by ischemia-reperfusion injury (IRI) that reduces blood flow (ischemia) and thus oxygen in the kidney causing kidney cell damage. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. In the worst cases of AKI, kidneys fail, leading to kidney dialysis or kidney transplant. At present, there are no therapeutic treatments available to prevent or treat CS-AKI or IRI. LSALT peptide targets the dipeptidase-1 (DPEP-1) pathway and has been shown to prevent inflammation and IRI to the kidneys in pre-clinical models, providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial. Ankündigung • Dec 22
Arch Biopartners Inc. Receives Approval from Ethics Committee in Turkey to Proceed with Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide Arch Biopartners Inc. announced that it received approval in Turkey from the Kocaeli University Clinical Research Ethics Committee to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. The ethics committee approval of the trial will be followed by a final regulatory review conducted by the Turkish Ministry of Health (MoH), expected to be completed by mid-January. Once the trial is approved by the MoH, activation of clinical sites in Turkey will take place and patient enrollment can begin in February. CS-AKI is often caused by ischemia-reperfusion injury (IRI) that reduces blood flow (ischemia) and thus oxygen in the kidney causing kidney cell damage. Once blood flow is restored to normal (reperfusion), inflammation is triggered and injury to kidney cells is exacerbated. In the worst cases of AKI, kidneys fail, leading to kidney dialysis or kidney transplant. At present, there are no therapeutic treatments available to prevent or treat CS-AKI or IRI. LSALT peptide targets the dipeptidase-1 (DPEP-1) pathway and has been shown to prevent IRI to the kidneys in pre-clinical models, providing the scientific rationale for Arch to use LSALT peptide in this CS-AKI trial. Advisory services and a funding contribution from the National Research Council of Canada Industrial Research Assistance Program(NRC-IRAP) announced by the Company in March 2023, will significantly offset the costs of the CS-AKI Phase II trial. Acute kidney injury (AKI) is a known common complication in patients after coronary artery bypass grafting (CABG) and other cardiac surgeries, including on-pump surgeries which increase the risk of AKI. The reported prevalence of CS-AKI is up to 30% and is independently associated with an increase in morbidity and mortality. Cardiopulmonary bypass (CPB) surgery occurs in nearly 1 million patients per year. Approximately 0.6% to 5% of patients undergoing cardiac surgery will require immediate postoperative dialysis or renal replacement therapy, and these patients have a very high early mortality rate up to 25% compared with 1% to 2% in patients who do not require immediate postoperative dialysis (Conlon et al, 19991, Chertow et al, 20052, Zakeri et al, 20053, Ivert et al, 20144, Harky et al, 20205). Ankündigung • Dec 13
Arch Biopartners Submits Application to Health Canada to Conduct the Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide Arch Biopartners Inc. announced it has submitted a Clinical Trial Application to Health Canada to obtain permission to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company's lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. This application, and one recently submitted in Turkey, follows the Company's submission of an Investigational New Drug Application to the U.S. Food and Drug Administration's (FDA). The FDA granted the Company permission to proceed with a Phase I trial in late June. The Phase II CS-AKI trial plans to recruit up to 240 patients and will be a double-blinded, placebo-controlled study conducted in hospital sites in Canada, Turkey and the United States. Patient recruitment is expected to begin in Turkey in early 2024, upon approval from the local ethics committee. Sites in the U.S. may be added in future. Once sites are active in the trial, patient recruitment will be done on a competitive basis between sites, until the planned total number of patients are recruited into the study. This study is designed to produce a signal of safety and efficacy that would support a larger Phase III trial, and eventually the approval of LSALT peptide as a new pharmaceutical product. Cardiac surgery-associated AKI is often caused by ischemia reperfusion injury (IRI) that reduces blood flow and thus oxygen (ischemia) in the kidney causing kidney cell damage. Cardiopulmonary bypass (CPB) surgery occurs in nearly 1 million patients per year. Approximately 0.6% to 5% of patients undergoing cardiac surgery will require immediate postoperative dialysis or renal replacement therapy, and these patients have a very high early mortality rate up to 25% compared with 1% to 2% in patients who do not require immediate postoperative dialysis (Conlon et al, 19991, Chertow et al, 20052, Zakeri et al, 20053, Ivertet al, 20144, Harky et al, 20205). Ankündigung • Sep 23
Arch Biopartners Inc Submits Application to the Turkish Ministry of Health to Conduct a Phase II Cardiac Surgery Associated-Acute Kidney Injury Trial for LSALT Peptide Arch Biopartners Inc. announced that it has submitted applications to the Ministry of Health (MoH) and local Ethics Committee in Turkey to obtain permission to proceed with a Phase II trial for LSALT peptide, targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI). LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver. This application in Turkey follows the Company’s submission of an Investigational New Drug Application to the U.S. Food and Drug Administration’s (FDA). The FDA subsequently granted the Company permission to proceed with this Phase II trial in late June. The CS-AKI trial plans to recruit up to 240 patients and will be a double-blind, placebo-controlled study conducted in hospital sites in the U.S., Turkey, and Canada. Of this total, the application to the MoH requests permission to recruit up to 150 patients in Turkey. Following approvals from the MoH and the Ethics Committee, patient recruitment is expected to begin as planned in the fall (fourth quarter) of 2023. The trial will begin with patient recruitment at clinical sites in Turkey, followed by eventual on boarding of clinical sites in the U.S. and Canada. There will be an independent Data Safety Monitoring Board which will monitor the safety of the patients enrolled in the trial. This study is designed to produce a signal of efficacy that would justify a larger Phase III trial.