Suzhou, China, May 6th, 2024——Accro Bioscience (Suzhou) Limited (Accropeutics) announced today that the first psoriasis patient has been dosed in the phase 2 clinical trial of the TYK2/JAK1 inhibitor AC-201 in China. This study is a multicenter, randomized, double-blind, parallel group, placebo-controlled phase II clinical trial to evaluate the efficacy, safety, and pharmacokinetic characteristics of AC-201 in subjects with moderate to severe plaque psoriasis.

AC-201 is a novel oral small-molecule inhibitor of TYK2/JAK1 with high activity, selectivity, and safety margin. AC-201 can effectively bind 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, and has no effect on the JAK2/JAK2 signaling pathway. AC-201 is intended to treat autoimmune diseases such as psoriasis and systemic lupus erythematosus. AC-201 has completed the long-term toxicity studies (including 3, 6, 9 -months) and reproductive toxicity studies (stages I and II). Study results indicate that AC-201 has an excellent safety profile and supports the clinical development of Phase II and III. AC-201 demonstrated excellent safety and tolerability in healthy volunteers in Australia and China. The average peak concentration and exposure level increased proportionally with dose, and were not affected by food. No significant drug accumulation was observed after multiple dosing of AC-201. Biomarkers indicated that low to middle doses of AC-201 effectively blocked disease causing pro-inflammatory cytokines. The overall phase I data support the progression of AC-201 to phase II for the treatment of psoriasis and other autoimmune disease patients.

Dr. Xiaohu Zhang, co-founder and CEO of Accropeutics, said, "We are very pleased that the first psoriasis patient has been dosed in the phase II clinical trials of AC-201. This is the first drug candidate of Accropeutics to enter phase II clinical trials, which is a great milestone for our team. We look forward to AC-201 demonstrating good efficacy and safety for psoriasis patients in phase II clinical trials.”

About Accropeutics

Accropeutics 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 RIPK1 inhibitor AC-003 completed phase I clinical trials in China and the United States in August 2023, and the clinical trials for aGVHD patients has been initiated; The RIPK2 inhibitor AC-101 has completed Phase I in Australia with excellent safety and PK/PD data; AC-201, a selective TYK2/JAK1 inhibitor with huge potential for treating inflammatory and autoimmune diseases, has completed Phase I in Australia and China, and is currently undergoing Phase II clinical trials in China. The company has multiple compounds in the PCC and preclinical research and development stages. Accropeutics owns global rights of all its assets with 17 patents issued in China, Japan, Korea, US and EU.