Insilico Medicine (HKEX:3696), a China-based, clinical-stage, generative AI-driven drug discovery company, announced on Tuesday that the inhalation solution of Rentosertib (ISM001-055), the company's first-in-class drug candidate with AI-identified novel target and AI-developed molecule structure, has received IND clearance from CDE.

This clearance supports a Phase I study to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of Rentosertib inhalation solution. The study will consist of a randomised, double-blind, placebo-controlled Phase I trial in healthy participants involving single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, as well as a non-randomised, open-label evaluation in patients with Idiopathic Pulmonary Fibrosis (IPF) receiving multiple doses.

Approximately 80 subjects are expected to be enrolled.

Insilico says that in preclinical studies, the inhalation solution of Rentosertib was able to achieve higher lung exposure with low systemic exposure and demonstrated antifibrotic and anti-inflammatory efficacy in animal models. Moreover, it showed good PK and safety profiles, as well as good stability and solubility.