China-based Insilico Medicine, a clinical-stage generative AI-driven drug discovery company, announced on Wednesday positive preliminary results from its Phase IIa clinical trial of ISM001-055.

ISM001-055 is a first-in-class small molecule aimed at TNIK (Traf2- and Nck-interacting kinase) and was designed using generative AI to treat idiopathic pulmonary fibrosis (IPF). The primary and the secondary efficacy endpoints of the study have been met, demonstrating dose-dependent response in forced vital capacity (FVC), a critical measure of lung function in IPF patients.

The company's proprietary AI platform facilitated ISM001-055's target identification and molecular design. The Phase IIa study was a randomised, double-blind, placebo-controlled trial that enrolled 71 patients with IPF across 21 sites in China. Patients were randomised to receive either placebo, 30mg once daily (QD), 30mg twice daily (BID) or 60mg QD for a period of 12 weeks.

Complete topline data will be released at an upcoming medical conference and clinical trial results will be submitted for publication in a peer-reviewed journal.