Suzhou China, June 21, 2023 —— Accropeutics Bioscience announced today that its oral small-molecule RIPK2 inhibitor AC-101 has been approved by the National Medical Products Administration (NMPA) to launch clinical phase I trial in China. The design is a randomized, double-blind, placebo-controlled, single dose, and multiple dose incremental phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and food effects of AC-101 in healthy adults. This is the forth clinical approval obtained by Accropeutics Bioscience this year.
AC-101 is the leading RIPK2 asset worldwide，an oral drug with novel mechanism of action may provide solution to the unmet medical needs for patients suffering from IBD. The first-in human dose of AC-101 in phase I clinical trial was conducted in Australia on April 12, 2023. Currently, the phase I trial in Australia is under smooth progress, and there are no adverse events (AEs) in the completed dose group.
About Accropeutics Bioscience
Accropeutics Bioscience 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 wrapping up Phase I in the United States and China, and is ready to dose patients for GVHD. The company’s RIPK2 inhibitor AC-101 was approved by HREC in March 2023 and is in Phase I in Australia. AC-201, a selective TYK2/JAK1 inhibitor with huge potential for treating inflammatory and autoimmune diseases, was approved by HREC in May 12, 2023 and is about to launch clinical trials in Australia. The company has multiple compounds in the PCC and preclinical research and development stages. Accropeutics Bioscience owns global rights of all its assets with more than 10 patents issued in China, Japan, Korea, US and EU.