Suzhou-based Accropeutics Bioscience announced positive results from a Phase II study for its AC-201 in treating moderate to severe plaque psoriasis. The multicenter, randomized, double-blind, placebo-controlled study enrolled 145 Chinese patients with moderate-to-severe plaque psoriasis, who were randomized to receive one of three different doses of AC-201 or placebo for 12 weeks.
Study Results
The results showed that all dose groups met the primary endpoint of PASI-75 response rate, as well as key secondary endpoints including PASI-90 and sPGA-0/1, with statistically significant superiority over the placebo group. AC-201 demonstrated favorable overall tolerability, with no serious adverse events or treatment discontinuations due to adverse events reported.
AC-201 Mechanism and Development
AC-201 is a novel, highly selective, and potent oral small-molecule TYK2/JAK1 inhibitor that effectively targets the pseudokinase domain (JH2) of TYK2/JAK1 while showing no impact on the JAK2/JAK3 pathway. With favorable pharmacokinetic properties and safety profile, the drug has completed Phase I studies in Australia and China, demonstrating good tolerability and effective suppression of pro-inflammatory cytokines. It is currently under development for immune-related diseases, including psoriasis, non-infectious uveitis, and systemic lupus erythematosus.
Future Development
These Phase II results support advancing AC-201 into Phase III development for plaque psoriasis treatment while highlighting its therapeutic potential across multiple immune-mediated disorders.-Fineline Info & Tech
