Junshi Biosciences has announced that its IL-17 antibody hit the goals of a phase 3 psoriasis trial in China, setting up the biopharma to seek national approval.
The Shanghai-headquartered company evaluated the anti-IL-17A monoclonal antibody, dubbed JS005, in a placebo-controlled study of patients with moderate to severe plaque psoriasis across 60 sites in China. IL-17A plays a major role in driving excess skin cell proliferation and activation in psoriasis.
The trial showed that JS005 resulted in a statistically significant and clinically meaningful improvement in the proportion of patients who achieved at least a 90% improvement in their Psoriasis Area and Severity Index (PASI 90) score compared to placebo, while the proportion of patients whose skin was deemed “clear” or “almost clear” was “significantly higher” in the JS005 group than in the placebo cohort, Junshi said in a Sept. 7 release.
It means the study hit its co-primary as well as secondary endpoints, according to the biopharma. The drug also showed a good safety profile, the company added.
With Junshi holding back any detailed data for a future medical conference, it’s not clear how JS005 performed in comparison to FDA-approved anti-IL-17 antibodies for psoriasis such as Novartis’ Cosentyx, UCB’s Bimzelx and Eli Lilly’s Taltz.
Professor Jianzhong Zhang, M.D., from the Peking University People’s Hospital—who led the study—claimed that “traditional treatments” for psoriasis “remain limited.”
“Results demonstrate JS005’s superior efficacy in achieving deep symptom remission, sustained therapeutic effects, and improved quality of life,” he added. “We hope this therapy will soon benefit millions of patients, further advancing China’s psoriasis treatment landscape.”
Junshi CEO Jianjun Zou, M.D., Ph.D., said hitting the primary endpoints “not only brings new hope to patients with moderate-to-severe psoriasis but also marks our innovation breakthrough in the autoimmune field.”
“Moving forward, we will actively collaborate with regulators to accelerate the availability of this innovative therapy, ensuring earlier patient access,” the CEO added.
The company—with approved drugs including the PD-1 checkpoint inhibitor Loqtorzi—is also evaluating JS005 in a phase 2 study for another inflammatory disease called ankylosing spondylitis.
Chinese regulators are currently mulling a psoriasis approval application for another IL-17A monoclonal antibody in the form of Akeso Biopharma’s gumokimab. The Hong Kong-based company said its phase 3 data last year demonstrated “superior outcomes” in a phase 3 psoriasis trial.