Insilico Advances AI-Designed IBD Drug Into Phase IIa as HK-Listed Platform Shows Pipeline Momentum

New updates have been reported about Insilico Medicine.

Insilico Medicine has dosed the first patient in BETHESDA, its Phase IIa trial of Garutadustat (ISM5411), an AI-designed, gut-restricted PHD inhibitor for inflammatory bowel disease (IBD), marking a key clinical milestone for the newly Hong Kong–listed biotech (03696.HK). The multicenter, randomized, double-blind, placebo-controlled study, led by gastroenterology expert Professor Minhu Chen, will enroll about 80 ulcerative colitis patients to evaluate safety, tolerability, pharmacokinetics, and early efficacy signals via clinical remission and response, endoscopy, histopathology, and biomarker readouts. Garutadustat, which recently received its USAN generic name, originated from Insilico’s Pharma.AI platform and was nominated as a preclinical candidate in January 2022 after only 12 months of AI-driven design and testing of roughly 115 compounds using the company’s Chemistry42 generative chemistry engine, underscoring a materially compressed R&D timeline relative to traditional discovery.

The asset’s dual mechanism—combining anti-inflammatory effects with enhancement of intestinal barrier repair—targets a significant unmet need in IBD, where more than half of patients fail or lose response to current immune-modulating therapies, and early Phase I data from Australia and China have shown favorable safety and gut-restricted exposure across dose levels. Insilico’s ability to move Garutadustat from concept to Phase IIa, alongside the recent out-licensing of another PHD program asset, ISM4808, to TaiGen Biotechnology in a multi–double-digit–million-dollar deal for anemia in chronic kidney disease, highlights growing commercial validation of its AI-enabled pipeline. The company reports that, across internal programs from 2021 to 2024, it now averages 12–18 months from project start to preclinical candidate with 60–200 molecules synthesized per program, versus the industry norm of roughly 4.5 years, suggesting structural efficiency advantages that could translate into a broader and faster-moving pipeline in fibrosis, oncology, immunology, pain, obesity, and metabolic disorders. For executives and investors, the Garutadustat Phase IIa initiation provides an early test of Insilico’s AI-driven model in a large, competitive IBD market and may serve as a key value inflection point depending on upcoming safety and efficacy data and potential partnering interest.