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 Peptide

The 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.¹

The 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/NCT04402957

The 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.

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