Accro Bioscience (Accro Bio) has dosed the first patient in its Phase IIb clinical trial assessing AC-101, a selective receptor-interacting serine/threonine-protein kinase 2 (RIPK2) inhibitor, in patients with moderate-to-severe ulcerative colitis (UC).
The placebo-controlled, double-blind, multi-centre study is planned to involve around 50 clinical sites.
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It will compare two AC-101 dose groups with a placebo arm.
The primary endpoint is the proportion of patients achieving clinical remission at week 12 while exploratory metrics will assess histologic remission and long-term remission maintenance.
AC-101 was developed using the company’s drug discovery platform focused on regulatory cell death and inflammation. The treatment is intended for moderate-to-severe UC.
RIPK2 is a mediator in the nucleotide-binding oligomerisation domain (NOD) signalling pathway.
Accro Bioscience said disruption of NOD/RIPK2 signalling has been associated with several inflammatory and autoimmune diseases, including inflammatory bowel disease.
The company has completed Phase I studies of AC-101 in healthy participants in Australia and China.
It reported a favourable safety and pharmacokinetic/pharmacodynamic profile from those studies, without providing further details in the announcement.
A Phase Ib proof-of-concept study has also been completed in Chinese patients with moderate-to-severe UC.
Accro Bioscience said the safety and efficacy findings from that study are due to be presented at United European Gastroenterology (UEG) Week 2026.
The company is a clinical-stage biotechnology firm focused on discovering, developing and commercialising treatments for inflammatory and autoimmune diseases.
Its research approach targets molecular mechanisms involved in regulatory cell death. The company’s pipeline includes compounds intended for these disease areas, including AC-101.
