Shanghai Junshi Biosciences announced that its anti-IL-17A monoclonal antibody JS005 has achieved positive results in a pivotal Phase 3 clinical trial for moderate to severe plaque psoriasis, meeting both co-primary endpoints and key secondary endpoints with statistically significant and clinically meaningful improvements. The company plans to submit a new drug application to regulatory authorities in the near future.
Phase 3 Trial Design and Results
The multi-center, randomized, double-blind, parallel, placebo-controlled pivotal registrational Phase 3 study (JS005-005-III-PsO) was led by Professor Jianzhong Zhang from Peking University People's Hospital and conducted across 60 clinical sites in China. The study's primary objective was to determine whether the proportion of participants achieving at least a 90% improvement in Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of 0 or 1 at Week 12 in the JS005 group were both superior to the placebo group.
Study results demonstrated that JS005 significantly improved the area and severity of psoriasis lesions in participants compared to placebo. The proportion of participants achieving an sPGA score of 0 or 1 was also significantly higher in the JS005 group. Additionally, JS005 demonstrated good safety in participants with moderate to severe plaque psoriasis.
Clinical Significance and Expert Commentary
Professor Jianzhong Zhang emphasized the clinical importance of these results, stating: "Patients with moderate-to-severe psoriasis suffer from long-term recurrent skin lesions and pruritus, imposing significant physical and mental burdens. Traditional treatments remain limited, making the success of this Phase 3 study for JS005 a significant milestone. Results demonstrate JS005's superior efficacy in achieving deep symptom remission, sustained therapeutic effects, and improved quality of life."
Dr. Jianjun Zou, General Manager and CEO of Junshi Biosciences, commented: "This milestone 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."
Disease Burden and Unmet Medical Need
Psoriasis represents a significant global health challenge, affecting approximately 125 million patients worldwide with a year-on-year increasing trend. The overall global prevalence ranges from 2.0% to 3.0%, while in China it is 0.47%. The disease is a chronic, recurrent, inflammatory, and systemic condition mediated by the immune system that seriously affects patients' physical and mental health.
Patients with moderate-to-severe psoriasis face increased risks of developing metabolic syndrome and atherosclerotic cardiovascular disease. Mental health conditions such as depression, anxiety, and suicidal tendencies caused by physical and psychological distress are also relatively common among psoriasis patients.
Mechanism of Action and Development Pipeline
JS005 is an anti-IL-17A monoclonal antibody independently developed by Junshi Biosciences. The drug targets interleukin-17A, a pleiotropic cytokine whose disordered secretion is closely related to the occurrence and progression of autoimmune diseases including psoriasis, rheumatoid arthritis, and ankylosing spondylitis.
By binding to IL-17A with high affinity and selectively blocking the binding of IL-17A with its receptor IL-17RA/IL-17RC, JS005 blocks the activation of downstream signaling pathways and the release of inflammatory factors, thereby effectively alleviating autoimmune disease symptoms.
Beyond psoriasis, Junshi Biosciences is advancing JS005 in other indications. All subjects in the Phase 2 clinical study of JS005 for the treatment of active ankylosing spondylitis have completed the primary endpoint visit and entered the extension treatment period.
Company Background
Founded in December 2012, Junshi Biosciences has established a diversified R&D pipeline comprising over 50 drug candidates across five therapeutic focus areas: cancer, autoimmune, metabolic, neurological, and infectious diseases. The company has received approvals for five products in China and international markets, including toripalimab, China's first domestically produced anti-PD-1 monoclonal antibody approved in 40 countries and regions including China, the US, and Europe.
