China-based generative artificial intelligence (AI)-driven biotech Insilico Medicine has announced that its lead pipeline candidate, INS018_055, has completed first dosing in patients in a Phase II clinical trial. This small-molecule, oral anti-fibrotic drug, entirely generated by Insilico’s AI platforms, is hailed as the world’s first AI-discovered molecule to reach the proof-of-concept stage.
Phase II Trial for Idiopathic Pulmonary Fibrosis
The Phase II trial for INS018_055 is assessing the molecule as a treatment for idiopathic pulmonary fibrosis, enrolling 60 patients across 40 sites in the US and China. Patients will be treated in four parallel cohorts for 12 weeks. This trial follows Insilico’s IND approval from the US FDA in June this year, with the first patients dosed in China on June 19, 2023.
Favorable Phase I Results
The molecule previously underwent Phase I testing in New Zealand and China, recruiting 126 healthy volunteers. The trials demonstrated a favorable safety, tolerability, and pharmacokinetic (PK) profile, supporting the progression to Phase II.
Insilico’s Pioneering Role in AI-Powered Drug Discovery
Established in 2014, Insilico is a global pioneer in AI-powered drug discovery. The firm applies its generative adversarial network (GAN)-based AI technologies to develop several discovery platforms, including the PandaOmic AI-powered novel target discovery engine, Chemistry42 deep generative reinforcement learning system, and InClinico, which predicts clinical trial outcomes. In addition to partnering with other biopharma companies, including a recent USD 1.2 billion deal with Sanofi, Insilico is also developing its own portfolio, with 12 preclinical candidates and 3 molecules currently at the clinical stage.-Fineline Info & Tech
