The biopharmaceutical company Insilico (03696) has announced the official initiation of a Phase 3 clinical trial for its internally developed drug candidate, Rentosertib (ISM001-055).

The trial details, registered under CTR20262475 and NCT07687459, have been officially posted on the Chinese National Medical Products Administration's (NMPA) Center for Drug Evaluation (CDE) platform and are also listed on the ClinicalTrials.gov website.

This prospective, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study is designed to evaluate the efficacy and safety of once-daily Rentosertib administration over a 52-week period.

The trial is expected to enroll a total of 320 participants across 47 research centers nationwide.

The study protocol involves both a treatment group and a control group, with participants randomly assigned to receive either Rentosertib or a placebo tablet.

The primary endpoint for the trial is the annual rate of decline in forced vital capacity (FVC) over the 52-week period.

Secondary endpoints will include time to first disease progression, changes in diffusing capacity of the lungs for carbon monoxide (DLCO), and quality of life measures based on questionnaire assessments.