Accropeutics Inc. Announces U.S. FDA Clearance of IND Application for RIPK2 Inhibitor AC-101

• Company to conduct a Phase II multi-regional clinical trial (MRCT) for the treatment of Ulcerative Colitis (UC)
• A Phase Ib Study of AC-101 for Ulcerative Colitis (UC) has been initiated in China
• AC-101 demonstrated a favorable safety and PK/PD profile in healthy volunteers in Phase Ia studies completed in Australia and China

NEW YORK and SUZHOU, China, Dec. 12, 2024 /PRNewswire/ -- Accropeutics Inc. (Accropeutics), a clinical-stage biotech company with a focus on molecular mechanisms of regulated cell death and related pathogenesis in human diseases, today 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."

About RIPK2

Receptor interacting protein kinase 2 (RIP2 or RIPK2) is a member of the receptor interacting serine/threonine protein kinase family. Dysregulation of NOD/RIPK2 dependent signaling pathways is associated with human diseases, such as inflammatory bowel disease (IBD) and sarcoidosis.

About AC-101

AC-101 was developed from the company's drug discovery platform targeting "regulatory cell death and inflammation". Preclinical studies show that AC-101 effectively inhibits the release of the NOD-RIPK2 dependent inflammatory factors and significantly protects tissue damage in IBD models. AC-101 is one of the leading RIPK2 assets worldwide.

About Accropeutics

Accropeutics Inc. is a clinical-stage biotech company with a core focus on molecular mechanisms of regulated cell death and related pathogenesis in human diseases. The Company has developed a robust portfolio with innovative compounds in various stages spanning from lead optimization to clinical trials. The RIPK1 inhibitor AC-003 completed phase I clinical trials in China and the United States in August 2023, and the clinical trials for aGVHD patients have been initiated; The RIPK2 inhibitor AC-101 has completed Phase I clinical trials in Australia and China with excellent safety and PK/PD data; AC-201, a selective TYK2/JAK1 inhibitor with broad potential for treating inflammatory and autoimmune diseases, has completed Phase I in Australia and China, and is currently undergoing Phase II clinical trial for Psoriasis in China. The company has multiple compounds in the PCC and preclinical research stages. Accropeutics owns global rights of all its assets with 21 patents issued in China, Japan, Korea, US and EU.

Contact: 
Accropeutics
Kenneth Gao
Senior Vice President
[email protected] 

SOURCE Accropeutics Inc.