AC-003

SUZHOU, China, May 24, 2023 /PRNewswire/ -- Accropeutics Bioscience announced that its oral small molecule TYK2/JAK1 inhibitor AC-201 has been approved by the Australian Human Research Ethics Committee (HREC) to launch a clinical phase I trial in Australia. The trial will be a randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and food effects of AC-201 in healthy adults. AC-201 is a novel small molecule inhibitor of TYK2/JAK1 with high activity, selectivity, and safety window. The preclinical studies have shown that AC-201 effectively binds to the pseudo kinase domain (JH2) of TYK2/JAK1, stabilizing the self-inhibitory conformation of the pseudo kinase domain on the kinase domain, thereby inhibiting the function of TYK2/JAK1 kinase. It demonstrated significant efficacy in multiple animal models of diseases, including psoriasis, and is intended for the treatment of psoriasis and other inflammatory and autoimmune diseases. As an oral drug candidate, AC-201 may provide convenience and efficacy with good safety for psoriasis patients. Dr. Xiaohu Zhang, Co-founder and CEO of Accropeutics Bioscience, said: "AC-201 is the third oral small molecule drug candidate developed by Accropeutics Bioscience to enter the clinical stage. Our company has obtained three clinical approvals this year and five since December 2021. We are committed to advancing these programs and aspire to bring relief to patients globally through these drug candidates ." 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 of innovative compounds in various stages of development, spanning from lead optimization to clinical trials. RIPK1 inhibitor AC-003 was approved for clinical testing by FDA and NMPA in December 2021 and August 2022, respectively. The phase I trial of AC-003 is wrapping up and a phase Ib-II trial is planned for aGVHD. In the Phase I study, AC-003 was rapidly absorbed in the gastrointestinal tract after oral administration, with a peak time of 1-2 hours. The peak concentration and exposure increased linearly for the 10-480 mg dose groups, and there was no drug accumulation after multiple dose administration. Pharmacokinetic parameters supported a once-daily dosing regimen. AC-003 was well tolerated with only grade 1 adverse events reported in the Chinese (Chinese, ethnic) and US (Caucasian, African-American, Asian) participants. RIPK2 inhibitor AC-101 was approved by HREC in March 2023 and is currently 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 2023 and is scheduled to launch clinical trial in Australia in the near future. The company has multiple compounds in PCC and preclinical stages. Accropeutics Bioscience owns global rights of all its assets with more than 10 patents issued in China, Japan, Korea, US and EU. Media Contact: Jie Xu, [email protected] SOURCE Accro Bioscience (Suzhou) Limited