Accro Bioscience Inc. (Accro Bio), a clinical-stage biotechnology company pioneering the development of novel therapeutics for immune mediated diseases, announced the dosing of their first patient in the Phase IIb clinical trial of AC-101, a selective RIPK2 inhibitor, in patients with moderate-to-severe ulcerative colitis (UC).

The Phase IIb study is a multicenter, double-blind, placebo-controlled clinical trial designed to evaluate AC-101 in patients with moderate-to-severe ulcerative colitis (UC). Planned across approximately 50 clinical sites, the trial features a three-arm design comprising two AC-101 dose cohorts and a placebo control arm. The primary endpoint is the clinical remission rate at Week 12. Exploratory endpoints include histologic remission, as well as the maintenance of clinical and histologic remission during long-term treatment.

AC-101 is a novel, selective RIPK2 inhibitor derived from Accro Bioscience's proprietary drug discovery platform targeting regulatory cell death and inflammation. It is being developed for the treatment of moderate-to-severe ulcerative colitis (UC). Receptor interacting protein kinase 2 (RIPK2) is a key mediator in the NOD signaling pathway, and dysregulation of NOD/RIPK2 signaling is associated with multiple inflammatory and autoimmune diseases, including inflammatory bowel disease (IBD).

AC-101 has completed Phase I studies in healthy participants in Australia and China, with favorable safety and PK/PD profile. A Phase Ib proof of concept study in Chinese patients with moderate-to-severe UC has been completed. The efficacy and safety results of this Phase Ib study will be presented at UEG Week 2026.