Junshi Biosciences Reports Positive Phase 3 Psoriasis Drug Results
The company's IL-17A inhibitor, JS005, meets primary endpoints in a pivotal study for moderate-to-severe plaque psoriasis, paving the way for regulatory submission.
Shanghai-based Junshi Biosciences announced that its pivotal Phase 3 clinical study for JS005, a novel treatment for moderate-to-severe plaque psoriasis, successfully met its primary endpoints. The positive data moves the company closer to seeking regulatory approval for a drug targeting a condition that affects approximately 125 million people worldwide.
The demonstrated that JS005, a recombinant humanized anti-IL-17A monoclonal antibody, delivered statistically significant and clinically meaningful improvements in psoriasis symptoms compared to a placebo. The study, which was multi-center, randomized, and double-blind, confirmed the drug's efficacy and safety profile.
Psoriasis is a chronic, immune-mediated inflammatory disease that causes significant physical and psychological distress for patients. JS005 enters a competitive but growing therapeutic area. The market for IL-17A inhibitors, a class of biologics that target a key cytokine in the inflammatory process, is currently dominated by major pharmaceutical players like Novartis with its drug Cosentyx and Eli Lilly's Taltz. This , highlighting the significant commercial opportunity for effective new treatments.
Professor Jianzhong ZHANG of Peking University People’s Hospital, the lead investigator, commented on the results, stating, 'Results demonstrate JS005’s superior efficacy in achieving deep symptom remission, sustained therapeutic effects, and improved quality of life. We hope this therapy will soon benefit millions of patients.' The company’s findings showed that JS005 significantly improved the area and severity of psoriasis lesions in participants.
Following the positive outcome, Junshi Biosciences plans to submit a new drug application to regulatory authorities in the near future. Dr. Jianjun ZOU, CEO of Junshi Biosciences, stated, 'This milestone not only brings new hope to patients with moderate-to-severe psoriasis but also marks our innovation breakthrough in the autoimmune field.' Success in this area would further diversify the company's R&D pipeline, which already includes treatments in oncology, metabolic diseases, and infectious diseases.