Suzhou China, April 12, 2023 —— Accro Bioscience (Suzhou) Limited announced today that the first subject has been dosed in a phase 1 clinical trial of AC-101 in Australia. AC-101 is a novel oral small-molecule inhibitor of RIPK2 which has been developed for the treatment of IBD. The aim of this trial is to evaluate the safety, tolerability, pharmacokinetics, and food effects of AC-101 in healthy adult subjects. Additionally, biomarker and PK/PD correlation will be explored, providing a scientific basis for the design and dosing regimen of phase II and III clinical trials.

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.

AC-101 was developed from the company's drug discovery platform targeting "regulatory cell death and inflammation". It is the second innovative oral small molecule inhibitor to be launched into clinical trial after AC-003, a potent RIPK1 inhibitor. 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 the leading RIPK2 asset worldwide. The current IBD treatments have many adverse factors: the serious side effects associated with long-term use of glucocorticoids, drug/drug interactions, long-term toxicity for immunosuppressants, and the loss of efficacy in some patients with biological agents. An oral drug with novel mechanism of action may provide solution to the unmet medical needs for patients suffering from IBD.

Dr. xiaohu Zhang, Co-founder and CEO of Accro, said: “AC-101 displays high activity and selectivity with wide safety window. It has the potential to become an effective treatment for IBD patients. We will work diligently to move the program forward, and hope AC-101 will one day help IBD patients worldwide.”

About Accro Bioscience

Accro Bioscience (Suzhou) Limited 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 company's RIPK1 inhibitor AC-003 was approved for clinical testing by FDA and NMPA in December 2021 and August 2022, respectively. AC-003 is in Phase I in the US and China. The company’s RIKP2 inhibitor AC-101 was approved by HREC in March 2023 for clinical testing and is in Phase I in Australia. In addition, AC-201, a selective TYK2/JAK1 inhibitor with huge potential for treating inflammatory and autoimmune diseases, has filed application for clinical testing in Australia. The company has multiple compounds in the PCC and preclinical research and development stages. Accro Bioscience owns global rights of all its assets with more than 10 patents issued in China, Japan, Korea, US and EU, etc.