Arch Biopartners Receives Ethics Committee Approval in Turkey to Dose Additional Patients in the Phase II Trial for LSALT Peptide
TORONTO, Feb. 02, 2021 (GLOBE NEWSWIRE) — Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that it received approval in Turkey from the İstanbul University-Cerrahpaşa, School of Medicine, Clinical Research Ethics Committee to dose twenty additional patients in the Phase II trial of its lead drug LSALT peptide (Metablok), targeting acute lung injury and acute kidney injury caused by inflammation in patients with severe cases of COVID-19.
Clinical sites in Istanbul and Ankara originally were approved to dose twenty patients who have since been successfully randomized into the double blind, placebo-controlled trial. The Ethics Committee approval to double the number of allowable patients in the Turkish portion of the study from twenty to forty was based on the safety results of the trial to date and the ongoing clinical need for treatments for hospitalized COVID-19 patients.The Ethics Committee approval will be followed by a regulatory review conducted by the Turkish Ministry of Health (MoH) before the additional patients can be randomized into the trial.To date, there have been approximately 20 patients dosed in North America in addition to the 20 patients dosed in Turkey. Recruitment and dosing of patients in the 60-patient study continues at hospital sites in the USA and Canada.About the Phase II trial for LSALT PeptideThe Phase II trial is an international, multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide (Metablok) as prevention of organ inflammation known to trigger acute respiratory distress syndrome (ARDS) and acute kidney injury (AKI) in patients infected with SARS-CoV-2 (COVID-19). ARDS is the leading cause of death in COVID-infected patients. AKI has been observed in approximately 35% of patients admitted to hospital with COVID-19 and is also a leading cause of mortality.1The composite primary endpoint of the Phase II trial reflects the severe effects often experienced by hospitalized COVID-19 patients and deemed appropriate for LSALT peptide’s novel mechanism of action in blocking consequential inflammation in the lungs, kidneys, and other organs.Additional information about the Phase II trial can be found at:https://clinicaltrials.gov/ct2/show/NCT04402957The Phase II results will be used to design the Phase III program, including greater patient numbers to more fully evaluate efficacy and safety in COVID-19 patients.About COVID-19COVID-19 is the disease caused by the novel coronavirus SARS-CoV-2 that emerged in China in late 2019. Severe complications from COVID-19 are in large part due to excessive host immune responses to the virus that result in progressive lung inflammation and acute respiratory distress syndrome that often requires mechanical ventilation and critical care1. Patients with severe COVID-19 also experience multiple organ dysfunction including acute kidney injury, liver dysfunction, cardiac failure, and blood abnormalities. Currently, no effective antiviral drug or specific treatment exists for SARS-CoV-2 infection. Treatment of severe COVID-19 has been primarily supportive, relying heavily on respiratory, infectious diseases, and critical care medicine.Survival rates and health care system capacity could both be improved with new treatments that prevent the severe manifestations of COVID-19, such as worsening lung inflammation (ARDS) and AKI experienced by patients infected with SARS-CoV-2.21 Hirsch JS et al. Acute kidney injury in patients hospitalized with COVID-19. Kidney Int. 2020
2 J. S. Ayres, Sci. Adv 10.1126/sciadv.abc1518 (2020)About Arch BiopartnersArch Biopartners Inc. is a clinical stage company focused on the development of innovative technologies that have the potential to make a significant medical or commercial impact. Arch is developing a pipeline of new drug candidates that inhibit inflammation in the lungs, liver and kidneys via the dipeptidase-1 (DPEP-1) pathway for multiple medical indications.For more information on Arch Biopartners, its technologies and other public documents Arch has filed on SEDAR, please visit www.archbiopartners.comThe Company has 61,362,302 common shares outstanding, following the exercise of 150,000 stock options by three directors for proceeds of $67,500.Forward-Looking StatementsAll statements, other than statements of historical fact, in this news release are forward looking statements that involve various risks and uncertainties, including, without limitation, statements regarding the future plans and objectives of the Company. There can be no assurance that such statements will prove to be accurate. Actual results and future events could differ materially from those anticipated in such statements. These and all subsequent written and oral forward-looking statements are based on the estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. The Company assumes no obligation to update forward-looking statements should circumstances or management’s estimates or opinions change.The science and medical contents of this release have been approved by the Company’s Chief Science OfficerThe Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain Covid-19 (or SARS-2 Coronavirus) at this timeNeither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release
For more information, please contact: Richard Muruve
Chief Executive Officer
Arch Biopartners, Inc.