Accropeutics' RIPK2 Inhibitor AC-101 IND Cleared by FDA

Accropeutics Inc., a biotech company focused on molecular mechanisms of cell death and related diseases, has received approval from the U.S. FDA to conduct a Phase II clinical trial for its drug AC-101, aimed at treating Ulcerative Colitis (UC). This trial marks an important step in evaluating the effectiveness and safety of AC-101 for patients suffering from moderate-to-severe UC. The study will be a 12-week, multi-regional, randomized, double-blind, placebo-controlled clinical trial, designed to gather comprehensive data on the drug's impact on UC patients.

In addition to the upcoming Phase II trial, Accropeutics has already commenced a Phase Ib study in China. This 12-week, multi-center, open-label study is focused on patients with moderate-to-severe UC. These trials are part of a broader effort to establish the drug's safety and efficacy, following successful Phase Ia trials in Australia and China. The earlier studies involved healthy volunteers and were aimed at assessing the safety, tolerability, pharmacokinetics, and dietary effects on the drug AC-101.

AC-101 is a RIPK2 inhibitor, developed through Accropeutics' proprietary drug discovery platform targeting regulatory cell death and inflammation. Preclinical studies have demonstrated AC-101's ability to inhibit the release of NOD-RIPK2 dependent inflammatory factors, offering significant protection against tissue damage in models of inflammatory bowel disease (IBD). This drug is considered one of the leading RIPK2 inhibitors globally.

Dr. Xiaohu Zhang, co-founder and CEO of Accropeutics, expressed enthusiasm over the FDA's IND clearance for AC-101, highlighting the drug as a pioneering RIPK2 inhibitor. He emphasized the company's commitment to advancing the development of AC-101, with the hope of providing effective and safe oral treatment options for patients with inflammatory bowel disease worldwide.

RIPK2, or receptor interacting protein kinase 2, is part of a family of protein kinases involved in cellular processes. Misregulation of the NOD/RIPK2 signaling pathways is linked to diseases such as inflammatory bowel disease and sarcoidosis, showcasing the importance of targeting this pathway in drug development.

Beyond AC-101, Accropeutics has a rich portfolio of innovative compounds. The company's pipeline includes the RIPK1 inhibitor AC-003, which completed Phase I trials in China and the U.S., and is now being tested in patients with acute graft versus host disease (aGVHD). Another compound, AC-201, a selective TYK2/JAK1 inhibitor, has shown promise for treating inflammatory and autoimmune diseases and is currently in a Phase II clinical trial for Psoriasis in China. Accropeutics holds global rights to its assets, supported by 21 patents across China, Japan, Korea, the U.S., and the EU.

Accropeutics continues to advance its research and development programs, leveraging its expertise in regulated cell death mechanisms to address unmet medical needs in inflammatory and autoimmune diseases. Through these efforts, the company aims to deliver innovative treatments that can significantly improve patient outcomes on a global scale.