Insilico Medicine, a clinical-stage biotechnology company powered by generative AI, has achieved a key milestone by dosing the first patient with Rentosertib in its pivotal Phase III trial, GENESIS-IPF-3, for idiopathic pulmonary fibrosis.
This accomplishment was made at Peking Union Medical College Hospital, with Shanghai Pulmonary Hospital enrolling its first patient concurrently.
GENESIS-IPF-3 is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of once-daily Rentosertib over 52 weeks. The trial is led by Professor Zuojun Xu of Peking Union Medical College Hospital, alongside co-principal investigators Academician Nanshan Zhong and President Chang Chen.
Rentosertib targets TNIK, a novel fibrosis-related pathway identified through AI-driven discovery. Promising improvements in lung function were observed in earlier Phase IIa results, and the Phase III study aims to validate these findings in a larger cohort. Regulatory approval could take three to four years under favorable conditions.
Insilico has documented Rentosertib’s development in peer-reviewed journals, including Nature Biotechnology and Nature Medicine, highlighting its AI-enabled discovery process, dose-dependent efficacy, and recent findings of reduced biological age markers.
This trial represents the world’s first Phase III study of a generative AI-discovered drug, marking a significant step forward in applying artificial intelligence to complex disease treatment.
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