Insilico Medicine Begins Phase III Rentosertib Trial in China

Insilico Medicine dosed the first patient in GENESIS-IPF-3, a Phase III trial of Rentosertib for idiopathic pulmonary fibrosis, the company said in a press release. Insilico describes the study as the world's first Phase III trial of a drug driven by generative AI. The first dose was administered at Peking Union Medical College Hospital, while Shanghai Pulmonary Hospital enrolled its first participant on the same day.

The randomized, double blind, placebo controlled study will evaluate once daily Rentosertib over 52 weeks. Insilico expects to enroll 320 participants across 47 centers in China. The primary endpoint is the annual rate of decline in forced vital capacity over 52 weeks, with time to a participant's first disease progression event as a key secondary endpoint.

Rentosertib, also known as ISM001-055 and INS018_055, is an investigational small molecule targeting TNIK that was developed using generative AI. Insilico describes it as potentially first in class. It has not received approval from any regulatory authority, though the FDA granted it Orphan Drug Designation for the disease in February 2023, which is a development incentive rather than a clearance to market.

Insilico says the drug's discovery, its Phase IIa results, its medicinal chemistry and related biological age findings have been published in Nature Biotechnology, Nature Medicine and the Journal of Medicinal Chemistry. Idiopathic pulmonary fibrosis is a chronic, progressive and irreversible scarring of the lungs that the company says affects about 5 million people worldwide.