Accropeutics Inc., a clinical-stage biotechnology company with operations in New York, US, and Suzhou, China, has announced that it has received approval from the US Food and Drug Administration (FDA) to commence a Phase II clinical study for its RIPK2 inhibitor, AC-101, in the treatment of ulcerative colitis (UC).
Design of the Phase II Study for AC-101
The Phase II study is a multi-region, randomized, double-blinded, parallel-group trial designed to assess the safety and efficacy of AC-101 in patients with moderate to severe UC. AC-101 is derived from Accropeutics’ proprietary “regulatory cell death and inflammation”-targeted R&D platform. Preclinical results have demonstrated that AC-101 effectively inhibits the release of inflammatory factors dependent on the NOD-RIPK2 pathway, showing significant protective effects in various animal models of inflammatory bowel disease (IBD). AC-101 is recognized as one of the world’s advanced RIPK2 inhibitors, intended for the treatment of IBD.
Accropeutics’ Clinical Pipeline
Accropeutics boasts a robust clinical pipeline with three products at various stages of clinical development. These include the RIPK1 inhibitor AC-003, the RIPK2 inhibitor AC-101, and AC-201, a selective TYK2/JAK1 inhibitor. The advancement of AC-101 to Phase II trials for UC is a significant milestone for the company, reflecting its commitment to developing innovative therapies for inflammatory conditions.-Fineline Info & Tech
