Arch Biopartners Establishes Australian Subsidiary for Metablok Phase I Trial in Acute Kidney Injury
核心洞察
Arch Biopartners has created Arch Clinical Pty Ltd in Australia to facilitate a Phase I safety trial for Metablok, a drug candidate targeting acute kidney injury (搜索).
The Phase I trial application has been submitted to the Alfred Health Human Research Ethics Committee, with a decision anticipated in early 2019.
The study will assess the safety and pharmacokinetics of Metablok (LSALT Peptide) in healthy participants through a double-blind, placebo-controlled design.
Arch Biopartners Inc. has announced the formation of a wholly-owned subsidiary in Australia, named Arch Clinical Pty Ltd, to advance the clinical development of Metablok, the Company’s lead drug candidate for treating acute kidney injury (搜索) (AKI). This strategic move supports an application to conduct a Phase I safety trial in Australia.
The Arch team initiated 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, followed by a full submission and review in early January 2019. A decision regarding trial approval was expected before February 2019.
The Phase I study is designed as a double-blind, placebo-controlled, randomized, single and multiple ascending dose study. It aims to evaluate the safety and pharmacokinetic profile of Metablok (LSALT Peptide) in healthy participants. The successful completion of this Phase I trial is a prerequisite for advancing to a Phase II trial, which will investigate Metablok’s efficacy in preventing AKI in patients undergoing cardiac surgery.
Metablok (LSALT Peptide) represents a novel therapeutic approach to AKI, a condition with limited treatment options and significant morbidity and mortality, especially in the context of major surgeries like cardiac surgery. The Phase II trial will be a critical step in determining whether Metablok can effectively reduce the incidence and severity of AKI in this high-risk patient population.