Accro Bioscience to Present Positive Phase II Results for AC-201 TYK2/JAK1 Inhibitor in Plaque Psoriasis at EADV Congress
核心洞察
Accro Bioscience (搜索) will present Phase II clinical data for AC-201, an oral selective TYK2 (搜索)/JAK1 (搜索) inhibitor, in moderate-to-severe plaque psoriasis (搜索) at the European Academy of Dermatology & Venereology Congress in Paris.
The company reports positive efficacy and safety readout from the Phase II randomized, double-blinded, placebo-controlled trial evaluating AC-201 in psoriasis (搜索) patients.
AC-201 is a novel small-molecule inhibitor that selectively targets the pseudo kinase domain of TYK2 (搜索)/JAK1 (搜索) with minimal effect on JAK2 (搜索) signaling pathways.
Accro Bioscience (搜索) announced it will present results from a Phase II clinical study evaluating AC-201, an oral selective TYK2 (搜索)/JAK1 (搜索) inhibitor, in moderate-to-severe plaque psoriasis (搜索) at the European Academy of Dermatology & Venereology (EADV) Congress in Paris from September 17-20, 2025. The company reported positive efficacy and safety readout from the completed Phase II trial.
Phase II Trial Design and Presentation Details
The study, titled "Efficacy and Safety of a Selective Oral TYK2 (搜索)/JAK1 (搜索) Inhibitor, AC-201, in Patients with Plaque Psoriasis (搜索): A Phase II, Randomized, Double-blinded, Placebo-Controlled Trial," will be presented as an oral presentation in the Late Breaking Sessions. The presentation is scheduled for Friday, September 19, from 17:15-17:30 in the Paris Nord session room.
AC-201 Mechanism and Development Program
AC-201 is a novel, highly selective and potent oral small-molecule inhibitor of TYK2 (搜索)/JAK1 (搜索) that binds to the pseudo kinase domain (JH2) of TYK2/JAK1, with minimal effect on the JAK2 (搜索)/JAK2 signaling pathway. The drug is currently being developed to treat immune mediated inflammatory diseases including psoriasis (搜索), non-infectious uveitis (搜索), and cutaneous lupus erythematosus (搜索).
Safety Profile from Phase I Studies
Phase I studies in healthy volunteers conducted in Australia and China demonstrated that AC-201 was generally safe and well-tolerated across all dose groups. The studies showed no adverse events leading to discontinuation or serious adverse events.
Company Pipeline and Intellectual Property
Accro Bioscience (搜索), a clinical-stage biotech company focused on molecular mechanisms of regulated cell death and related pathogenesis in human diseases, currently has three clinical-stage assets. Beyond AC-201, the company is developing AC-101, a RIPK2 (搜索) inhibitor that has completed Phase I studies in Australia and China with excellent safety and pharmacokinetic/pharmacodynamic data, with a Phase Ib trial in ulcerative colitis (搜索) patients currently ongoing. The company's third asset, AC-003, a RIPK1 (搜索) inhibitor, has obtained Orphan Drug Designation from the FDA and completed Phase I studies in China and the United States, currently advancing in a Phase Ib trial for acute graft-versus-host disease (搜索) patients.
Accro Bioscience (搜索) owns global rights to its assets with 25 patents issued in China, Japan, the United States, Korea, and the European Union.