Arch Biopartners Receives Health Canada Approval to Conduct COVID-19 Phase II Human Trial

TORONTO, May 08, 2020 (GLOBE NEWSWIRE) -- Arch Biopartners Inc., (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) a clinical stage company developing new drug candidates for treating organ damage caused by inflammation, today announced it has received a No Objection Letter from Health Canada to conduct a Phase II human trial for its lead drug LSALT peptide (Metablok) to prevent organ inflammation experienced by patients with COVID-19.

The Phase II trial will be a multicenter, randomized, double-blind, placebo-controlled, proof of concept study of LSALT peptide. The primary endpoint is to prevent the development of life threatening acute respiratory distress syndrome (ARDS) in patients early in the course of COVID-19.

A secondary endpoint of the Phase II trial is to prevent kidney inflammation and injury, which also contributes to mortality and occurs in up to 30% of patients with severe COVID-19.

The trial will begin with the enrolment of 60 hospitalized patients who will receive either LSALT peptide or drug-free saline daily for up to 14 days. There will be an option to expand the study to include a larger number of subjects.

As a result of clinical interest to support the Phase II trial in the United States, Arch continues to be in dialogue with the U.S. Food and Drug Administration to obtain permission to recruit patients at American clinical sites into the trial.

About COVID-19

COVID-19 is the disease caused by the novel coronavirus SARS-CoV-2 that emerged in China in late 2019. Patients with severe COVID-19 develop progressive lung inflammation and acute respiratory distress syndrome that often requires mechanical ventilation and critical care. Patients with severe COVID-19 also experience multi-organ dysfunction including acute kidney injury, liver dysfunction, cardiac failure and blood abnormalities. Currently, no vaccine or effective antiviral drug exists for SARS-CoV-2. Treatment of COVID-19 has been primarily supportive, relying on critical care physicians.

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 acute kidney injury experienced by patients infected with SARS-CoV-2.

About Arch Biopartners

Arch 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 drug library to produce new drug candidates that inhibit inflammation in the lungs, liver and kidneys caused via the dipeptidase-1 (DPEP-1) pathway.