Accropeutics Doses First Patient in Phase Ib Trial of AC-101 for Moderate-to-Severe Ulcerative Colitis

14 February 2025 | Friday | News


AC-101, a novel RIPK2 inhibitor, enters clinical evaluation in China, paving the way for multi-regional trials as a potential non-immunosuppressive treatment for inflammatory bowel diseases.
Image Source : Public Domain

Image Source : Public Domain

Accropeutics Inc. (Accropeutics), a clinical-stage biotechnology company pioneering the development of novel therapeutics that target molecular mechanisms of regulated cell death for immune mediated diseases, today announced the dosing of their first patient in the Phase Ib clinical trial of AC-101. AC-101 is a novel RIPK2 inhibitor being developed for the treatment of moderate-to-severe Ulcerative Colitis (UC).

This multi-center, open-label clinical trial will evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of AC-101 in Chinese patients with moderate-to-severe UC. Accropeutics recently secured U.S. FDA IND clearance for AC-101 to enable its planned Phase 2 Multi-Regional Clinical Trial (MRCT) for this indication.

Dr. Xiaohu Zhang, co-founder and CEO of Accropeutics said, "Dosing of the first patient in AC-101's Phase 1b study represents a significant step towards advancing this novel oral therapeutic for treatment of patients suffering from Ulcerative Colitis. We believe that RIPK2 comprises a critical target in the pathogenesis of inflammatory bowel disease, including Ulcerative Colitis and Crohn's Disease, and that targeting it with AC-101 will provide a novel front-line option to patients in urgent need of efficacious, non-immunosuppressive treatments."

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