Arch Biopartners Receives Health Canada Authorization to Amend Phase II Trial Protocol for LSALT Peptide

TORONTO, March 16, 2021 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), a clinical stage company developing new drug candidates for preventing organ inflammation, announced today that Health Canada has provided a No Objection Letter for the Company’s protocol amendments for 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.

The protocol amendments were recommended by clinical investigators and key medical advisors assisting with the study and were based on information gathered to date from the first 45 patients recruited into the Phase II trial. The changes to the protocol were designed to facilitate enrollment and execution of the sixty-patient study, improve patient care for those undergoing treatment and to broaden patient eligibility to receive Metablok.

The amendments approved by Health Canada include the lowering of the minimum age of patients admissible into the trial to 18 years from 45 and a simplified treatment regimen including the reduction in daily blood draws based on the safety profile observed in prior patients.

The amended protocol has now been distributed to the two clinical sites currently active in Calgary, Canada and will be adopted by the Canadian clinical teams following local internal review board approval. The amended protocol will also be submitted to the U.S. FDA, as well as the Turkish Ministry of Health, with adoption by the participating clinical sites in the USA and Turkey as soon as possible.

“We appreciate the rapid review and approval of the protocol amendment by Health Canada. The amended protocol will broaden the patient base and simplify our Phase II trial for Metablok. We look forward to the approval of the amendment by the respective ethic committees to make our trial more patient friendly, less labour intensive and more inclusive for a wider range of patients,” said Richard Muruve, CEO of Arch.

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) or new variants of the virus. 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