Insilico Medicine Launches First-in-Human Trial for AI-Discovered IBD Drug –

Insilico Medicine Launches First-in-Human Trial for AI-Discovered IBD Drug -


What You Should Know:

  • Insilico Medicine (“Insilico”), a generative artificial intelligence (AI)-driven clinical-stage biotechnology company, today announced that the company has initiated the first-in-human study for ISM5411, a potentially first-in-class PHD inhibitor for the treatment of inflammatory bowel disease (IBD).
  • Designed and developed by Insilico’s proprietary end-to-end AI drug discovery platform, Pharma.AI, ISM5411 is Insilico’s fifth AI drug program to enter the clinic. 

AI-Driven Advancements in the Eradication of GI Diseases

Insilico’s Phase I study of ISM5411, aimed at assessing safety, tolerability, pharmacokinetics, and food effects in 76 healthy subjects, has completed its initial dose in Australian volunteers. Following Phase Ia, the company plans global Phase Ib trials for ulcerative colitis patients. Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn’s disease, impacts global populations, with 3 million U.S. adults affected. Incurable and raising colorectal cancer risk, current IBD treatment offers limited mucosal healing improvement.

 Research identifies prolyl hydroxylase (PHD) as a crucial regulator in IBD, a potential treatment target. Insilico nominated ISM5411, developed by their AI engine, as a preclinical drug candidate for IBD, showing promising safety and efficacy. The company, utilizing generative AI, combines artificial intelligence with cutting-edge technologies and boasts a portfolio of over 30 pipelines, with four programs in the clinical stage, developed using Pharma.AI. Recently, Insilico established an AI R&D Center in Montreal, Canada, enhancing its AI algorithm research and platform-building capabilities.

“IBD impacts a large patient population who currently have limited therapeutic options,” says Sujata Rao, MD, Chief Medical Officer at Insilico Medicine who is leading the clinical trial.“We believe this new treatment – which is potentially first-in-class – could offer a promising alternative.”  



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