China-based artificial intelligence (AI) drug developer Insilico Medicine has reported initial positive data from its Phase IIa study for ISM001-055, an in-house generative AI-generated drug candidate for idiopathic pulmonary fibrosis (IPF). The molecule, which targets TNIK (Traf2- and NCK- interacting kinase), has shown a positive safety profile and dose-dependent lung function response in forced vital capacity (FVC), a key indicator of lung function in IPF patients.
The study (NCT05938920) was a randomized, double-blind, placebo-controlled trial that enrolled 71 patients with IPF across 21 sites in China. Patients were administered either ISM001-055 or placebo, with dosages of 30mg once daily (QD), 30mg twice daily (BID), or 60mg QD for 12 weeks. The 60mg QD dosage group achieved significant FVC benefits.
Insilico has also initiated a parallel Phase II trial for the drug candidate in the US, with full details of the interim findings expected to be presented at industry conferences and published in the near future.
Dr. Alex Zhavoronkov, co-CEO of Insilico Medicine, has described the results as a “critical milestone in AI-powered drug discovery,” noting the highly positive signs of dose-dependent efficacy after a short dosing period, which bodes well for the molecule’s potential in later-stage studies.- Flcube.com
