Accropeutics Inc. (Accropeutics), a clinical-stage biotech company with a focus on molecular mechanisms of regulated cell death and related pathogenesis in human diseases,  announces that its RIPK2 inhibitor AC-101 has received clearance from the U.S. FDA for a Phase II clinical trial for the treatment of Ulcerative Colitis (UC). The Phase II trial will be a 12-week, multi-regional, randomized, double-blind, placebo-controlled, parallel group clinical trial, to evaluate the safety and efficacy of AC-101 in patients with moderate-to-severe Ulcerative Colitis (UC). 

Separately, a 12-week, multi-center, open-label, parallel group Phase Ib study of AC-101 in patients with moderate-to-severe Ulcerative Colitis (UC) has been initiated in China. Earlier this year, the company has successfully completed a Phase Ia clinical trial in Australia, which was a single center, randomized, double-blind, placebo-controlled, single and multiple ascending dose study following oral administration in healthy human subjects, in evaluating the safety, tolerability, pharmacokinetics and the effects of food of AC-101. A Phase Ia bridging study of AC-101 in China has also been finished.

Dr. Xiaohu Zhang, co-founder and CEO of Accropeutics said, "We are thrilled to receive FDA clearance of IND for AC-101, which is one of the leading RIPK2 inhibitors worldwide. We look forward to evaluating AC-101 for more safety and efficacy data in UC patients in the Phase II study. We will work diligently to move the program forward, in the hope that it would one day benefit IBD patients worldwide with safe and efficacious oral treatment options."