Suzhou China, November 26, 2024 - Accro Bioscience (Suzhou) Limited (Accropeutics), a clinical-stage biotech company with a focus on molecular mechanisms of regulated cell death and related pathogenesis in human diseases, today announced that the highly selective TYK2/JAK1 inhibitor AC-201 has received approval from the National Medical Products Administration (NMPA) for a phase II clinical trial to treat non-infectious uveitis. This trial is a multicenter, randomized, double-blind, parallel group phase II clinical trial evaluating the efficacy and safety of AC-201 in patients with active non-infectious uveitis. In 2023, AC-201 already received the NMPA clearance for phase II clinical trial for the treatment of Psoriasis.

Non-infectious uveitis (NIU) is a complex autoimmune or inflammatory disease that can cause damage to retinal tissue and is one of the main causes of blindness. NIU can be accompanied by various systemic autoimmune or autoimmune inflammatory diseases. A considerable number of NIU patients have poor response to glucocorticoids, immunosuppressants, and biologics, which is a major challenge in NIU treatment. AC-201, an oral drug candidate targeting TYK2/JAK1, is expected to provide a new treatment option for NIU patients worldwide.

Dr. Zhang Xiaohu, co-founder and CEO of Accropeutics said, “We are thrilled that NMPA approved IND for the second indication of AC-201 which is an important milestone for the asset and for our company. We look forward to evaluating the effectiveness and safety of AC-201 in NIU patients.”

About AC-201
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, NIU and systemic lupus erythematosus. AC-201 demonstrated excellent safety and tolerability in phase I 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. In addition, AC-201 has completed the long-term and reproductive toxicity studies with excellent safety profile, which supports the development of AC-201 for the treatment of psoriasis, NIU and other autoimmune disease in phase II and III 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 phase II clinical trials. The RIPK1 inhibitor AC-003 has completed phase I clinical trials in China and the United States in August 2023, and clinical trials for aGVHD patients have been initiated; The RIPK2 inhibitor AC-101 has completed Phase I in Australia and China 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 for psoriasis in China. The company has multiple compounds in PCC and preclinical research and development stages. Accropeutics owns global rights of all its assets with 19 patents issued in China, Japan, Korea, US and EU.