Therapy Areas
Accropeutics Bioscience's AC-201 phase I trial receives Australian regulatory approval
25 May 2023 -

Accropeutics Bioscience, a China-based clinical-stage biotech company, announced on Wednesday that the company has received approval from the Australian Human Research Ethics Committee (HREC) to launch a clinical phase I trial of its oral small molecule TYK2/JAK1 inhibitor AC-201 in Australia.

The trial, a randomised, double-blind, placebo-controlled, single and multiple ascending dose study, is to assess the safety, tolerability, pharmacokinetics, and food impacts of AC-201 in healthy adults.

AC-201 is a novel small molecule inhibitor of TYK2/JAK1 with high activity, selectivity, and safety window. The preclinical studies have indicated that the product effectively binds to the pseudo kinase domain (JH2) of TYK2/JAK1, stabilising the self-inhibitory conformation of the pseudo kinase domain on the kinase domain, thereby inhibiting the function of TYK2/JAK1 kinase. It showcased significant efficacy in multiple animal models of diseases, including psoriasis, and is aimed at the treatment of psoriasis and other inflammatory and autoimmune diseases. The company said that it is expected to provide convenience and efficacy with good safety for psoriasis patients.