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Insilico Medicine Advances AI-Designed IBD Drug Garutadustat Into Phase IIa Trial

Story Highlights
  • Insilico has begun dosing patients in a Phase IIa trial of Garutadustat, an AI-designed gut-restricted PHD inhibitor for ulcerative colitis.
  • The BETHESDA study builds on positive Phase I data and underscores Insilico’s strategy to leverage generative AI to address major unmet needs in inflammatory bowel disease.
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Insilico Medicine Advances AI-Designed IBD Drug Garutadustat Into Phase IIa Trial

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InSilico Medicine Cayman TopCo ( (HK:3696) ) just unveiled an update.

Insilico Medicine has dosed the first patient in BETHESDA, a multicenter, randomized, double-blind, placebo-controlled Phase IIa trial of Garutadustat (ISM5411), its gut‑restricted, AI-designed prolyl hydroxylase domain (PHD) inhibitor for inflammatory bowel disease, in about 80 patients with ulcerative colitis. The study, led by prominent Chinese gastroenterologist Professor Minhu Chen, will evaluate safety, tolerability, pharmacokinetics and early efficacy signals, advancing a candidate that has already shown favorable safety and gut-restricted pharmacokinetics in Phase I studies and was recently highlighted in Nature Biotechnology, reinforcing Insilico’s positioning as a frontrunner in applying generative AI to address unmet needs in IBD and potentially expand its clinical and commercial footprint in this high‑burden market.

More about InSilico Medicine Cayman TopCo

Insilico Medicine Cayman TopCo, listed in Hong Kong, is a clinical-stage biopharmaceutical company that uses generative artificial intelligence platforms such as Pharma.AI and Chemistry42 to discover and develop novel drug candidates. The group focuses on AI-designed small molecules across multiple therapeutic areas, with a growing emphasis on inflammatory and gastrointestinal diseases where there is significant unmet medical need.

Average Trading Volume: 9,088,700

Current Market Cap: HK$26.2B

For detailed information about 3696 stock, go to TipRanks’ Stock Analysis page.

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