Accropeutics Begins Dosing in Phase Ib Study of RIPK2 Inhibitor AC-101

Accropeutics Inc., a biotechnology company at the forefront of developing innovative treatments, has taken a significant step in its quest to address immune-mediated diseases. On February 13, 2025, the company announced the initiation of a Phase Ib clinical trial for AC-101, with the dosing of the first patient. AC-101 is a cutting-edge RIPK2 inhibitor aimed at treating moderate-to-severe Ulcerative Colitis (UC), a chronic inflammatory disease of the colon.

The trial, which is open-label and multi-center, is focused on assessing the safety, tolerability, initial efficacy, and pharmacokinetics of AC-101 in Chinese patients suffering from moderate-to-severe UC. Accropeutics has also obtained clearance from the U.S. FDA for an Investigational New Drug (IND) application, facilitating the planned Phase 2 Multi-Regional Clinical Trial for AC-101.

Dr. Xiaohu Zhang, the co-founder and CEO of Accropeutics, emphasized the importance of this trial. He remarked that the dosing of the first patient represents crucial progress in the development of AC-101 as a novel oral therapy for Ulcerative Colitis. Dr. Zhang highlighted the significance of RIPK2 as a pivotal target in inflammatory bowel diseases such as Ulcerative Colitis and Crohn's Disease. By inhibiting RIPK2 with AC-101, Accropeutics aims to offer a novel treatment option that is not based on immunosuppression, providing hope for patients in dire need of effective therapies.

Ulcerative Colitis is characterized by chronic inflammation of the digestive tract, particularly affecting the large intestine. The disease follows an intermittent relapsing-remitting pattern, causing recurrent flares and cumulative morbidity. Long-term sufferers face an increased risk of colorectal cancer. Additionally, the condition often leads to psychological issues such as stress, anxiety, and depression, severely affecting patients' quality of life and productivity. Despite the availability of advanced treatments, many drugs offer limited clinical remission rates, between 20-30%, and patients often experience a secondary loss of response after initial improvement.

RIPK2, or receptor interacting protein kinase 2, plays a crucial role in immune-mediated inflammatory diseases like inflammatory bowel disease. The dysregulation of the NOD/RIPK2 signaling pathway is linked to several such conditions, making it a target for innovative therapeutic approaches.

AC-101 has emerged from Accropeutics' "regulatory cell death and inflammation" drug discovery platform. Preclinical studies demonstrated that AC-101 effectively inhibits the inflammatory factors dependent on the NOD-RIPK2 pathway, providing significant protection against tissue damage in nonclinical in-vivo models. Prior Phase I clinical testing in Australia and China has shown promising safety and pharmacokinetic/pharmacodynamic signals for AC-101.

Accropeutics Inc. continues to forge ahead in the biotechnology landscape, focusing on discovering, developing, and commercializing novel therapies for immune-mediated inflammatory diseases. The company boasts a diverse portfolio of innovative compounds at various development stages, from lead optimization to clinical testing. Among its achievements, AC-003, a selective RIPK1 inhibitor, has completed phase I clinical trials in China and the U.S. and is now in phase Ib trials for aGVHD. AC-201, a TYK2/JAK1 inhibitor, has concluded Phase I testing in Australia and China and is currently in a Phase II psoriasis trial in China. Accropeutics owns global rights to all its assets, supported by 23 patents issued in China, Japan, Korea, the U.S., and the EU.