Suzhou China, May 12, 2023 —— Accro Bioscience (Suzhou) Limited announced today that its oral small-molecule TYK2/JAK1 inhibitor AC-201 has been approved by the Australian Human Research Ethics Committee (HREC) to launch clinical phase I trial in Australia. The design is a randomized, double-blind, placebo-controlled, single dose, and multi dose incremental phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and food effects of AC-201 in healthy adults.

AC-201 is a novel oral small-molecule inhibitor of TYK2/JAK1 with high activity, selectivity, and safety window. The preclinical studies have shown that 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. It demonstrated significant efficacy in multiple animal models including psoriasis and is intended for the treatment of psoriasis and other inflammatory and autoimmune diseases.

Psoriasis is an immune-mediated chronic, recurrent, inflammatory, and systemic disease induced by the combined effects of genetics and environment. Its clinical manifestations are localized or widely distributed squamous erythema/plaques, which can present with pustules and other systemic symptoms, including joint damage, metabolic syndrome, cardiovascular disease, inflammatory bowel disease, and chronic kidney disease. According to the epidemiological statistics in 2019, there were 4,622,594 cases of psoriasis in the world. Drugs for psoriasis treatment include: glucocorticoid (long-term use is easy to cause serious side effects such as skin atrophy, and withdrawal is easy to cause disease rebound), vitamin D3 derivatives (causing irreversible elevation of serum calcium level), retinoic acids (teratogenic, causing irritant dermatitis and photosensitivity), methotrexate (bone marrow suppression, hepatotoxicity, gastrointestinal reactions, teratogenic and lung damage and other adverse reactions). Biological agents such as TNF- α, IL-17A, and IL-23 inhibitors are highly effective but suffer from diminished efficacy over time, infections and allergic reactions. AC-201 as an oral small molecule drug candidate may provide convenience and efficacy with good safety to psoriasis patients.

Dr. Xiaohu Zhang, Co-founder and CEO of Accro Bioscience, said: “AC-201 is the third oral small-molecule drug candidate developed by Accro Bioscience to enter clinical stage. This is the third clinical approval obtained by Accro Bioscience this year, and the fifth since December 2021. We will work diligently to move the programs forward, and hope these drug candidates will one day help 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 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. Accro Bioscience owns global rights of all its assets with more than 10 patents issued in China, Japan, Korea, US and EU.