Insilico Medicine announced that the inhalation formulation of Rentosertib (ISM001-055) has received investigational new drug clearance from China’s Center for Drug Evaluation, clearing the way for a direct-to-lung Phase 1 clinical study.
The IND supports a two-part trial: a randomized, double-blind, placebo-controlled single-ascending-dose and multiple-ascending-dose study in healthy volunteers, and a non-randomized, open-label multiple-dose evaluation in patients with idiopathic pulmonary fibrosis, with approximately 80 subjects expected.
The inhalation solution is intended to deliver targeted lung exposure, achieving faster onset and higher local bioavailability at lower doses while reducing systemic exposure, the company claims.
Rentosertib, described by Insilico as a potential first-in-class small-molecule TNIK inhibitor, was discovered using the firm’s Pharma.AI platform and previously showed favorable tolerability and dose-dependent efficacy signals in an oral Phase IIa study. Insilico characterizes the inhalation IND as the 13th program from its AI-driven pipeline to receive clearance and says the milestone supports the reproducibility of its AI-driven discovery workflow.
