TORONTO, Dec. 11, 2018 (GLOBE NEWSWIRE) — Arch Biopartners Inc., (Arch or the Company) (TSX Venture: ARCH and OTCQB: ACHFF) today announced it has formed a 100% owned subsidiary in Australia, named Arch Clinical Pty Ltd, to pursue an application to perform a phase I safety trial in Australia for Metablok, the Company’s lead drug candidate for treating acute kidney injury.
The Arch team has started the human trial application process with the Alfred Health Human Research Ethics Committee (HREC). The draft application was accepted for registration on December 10, 2018 and will be followed by the full submission and review in early January 2019. A decision regarding trial approval is expected before February 2019.
The Phase I study will be a double-blind, placebo-controlled, randomized, single and multiple ascending dose study to evaluate the safety and pharmacokinetic profile of Metablok (LSALT Peptide) in healthy participants. A successful Phase I trial will be followed by a Phase II trial to investigate Metablok’s efficacy in the prevention of acute kidney injury in cardiac surgery patients.