Generative AI-powered longevity biotech Insilico Medicine has administered the first dose of its anti-fibrotic small molecule inhibitor in a Phase II clinical trial in subjects with idiopathic pulmonary fibrosis (IPF), a chronic lung disease causing irreversible lung function decline.
The trial marks the first time a generative AI has been used to discover and design an anti-fibrotic drug. In February 2023, INS018_055 was granted Orphan Drug Designation by the FDA. The randomized, double-blind, placebo-controlled trial will enroll 60 IPF patients across 40 sites in the United States and China, divided into four parallel cohorts.
“With demonstrated potential against both fibrosis and inflammation, INS018_055 could offer another option for patients worldwide,” said Dr Feng Ren, co-CEO and Chief Scientific Officer of Insilico. “The achievement of the first dose for INS018_055 in the Phase II clinical trial is not only an important step for Insilico, but also a milestone for AI-driven drug discovery and development.”
INS018_055, has already demonstrated positive results in Phase I trials, which involved healthy subjects. It shows promise in combating fibrosis and inflammation, offering a potential treatment option for patients worldwide.
“When we started developing generative AI for drug discovery, I never expected to see the clinical and preclinical results we have today,” said Dr Alex Zhavoronkov, co-CEO of Insilico Medicine. “Initiating Phase II trials with this novel inhibitor for IPF represents a major milestone for deep generative reinforcement learning in drug discovery.”
Insilico Medicine has a robust portfolio of over 30 assets, with 12 preclinical candidates nominated since 2021 and three candidates advancing to the clinical stage. The company introduced the concept of using generative AI for designing novel molecules in a peer-reviewed journal in 2016. Since then, the company has developed and validated various approaches and features for its generative AI platform, which encompasses generative biology, chemistry and medicine.