Junshi Biosciences' new psoriasis drug meets the primary endpoint in Phase III clinical trial, set to file for marketing approval

Junshi Biosciences recently announced that its independently developed recombinant humanized anti-IL-17A monoclonal antibody (product code: JS005) has achieved positive results in a pivotal Phase III registrational clinical study (Study ID: JS005-005-III-PsO) for the treatment of moderate-to-severe plaque psoriasis. This multicenter, randomized, double-blind, parallel-group, placebo-controlled trial demonstrated statistically significant and clinically meaningful improvements in both the co-primary and key secondary endpoints. Junshi Biosciences plans to submit a marketing authorization application for JS005 to regulatory authorities in the near future.

Psoriasis is a common, chronic, recurrent, inflammatory, and systemic disease mediated by the immune system. Psoriasis can be associated with abnormalities in other systems, and patients with moderate to severe psoriasis face an increased risk of metabolic syndrome and atherosclerotic cardiovascular disease. Mental illnesses caused by depression, anxiety, and physical and mental distress are also prevalent among psoriasis patients. Therefore, psoriasis is a disease that significantly impacts the physical and mental health of patients and is a worldwide urgent issue that needs to be addressed.

JS005 is a specific anti-IL-17A monoclonal antibody independently developed by Junshi Biosciences. IL (Interleukin)-17A is a pleiotropic cytokine, and its secretion imbalance is closely related to the occurrence and development of autoimmune diseases such as psoriasis, rheumatoid arthritis, and ankylosing spondylitis. JS005 effectively alleviates symptoms of autoimmune diseases by binding with high affinity to IL-17A and selectively blocking the interaction between IL-17A and its receptors IL-17RA/IL-17RC, thereby inhibiting the activation of downstream signaling pathways and the release of inflammatory factors. As of now, the Phase 3 clinical study of JS005 for the treatment of moderate to severe plaque psoriasis has achieved both co-primary endpoints and key secondary endpoints. All participants in the Phase 2 clinical study of JS005 for the treatment of active ankylosing spondylitis have completed the primary endpoint visit and entered the extended treatment period.

This multicenter, randomized, double-blind, parallel, placebo-controlled pivotal Phase 3 registration clinical study (Study Number: JS005-005-Ⅲ-PsO) of JS005 has been successfully completed and met the co-primary endpoints and key secondary endpoints. The study was led by Professor Zhang Jianzhong from Peking University People's Hospital as the principal investigator and conducted across 60 research centers in China. Its primary objective was to evaluate whether the proportion of participants achieving at least a 90% improvement in Psoriasis Area and Severity Index (PASI 90) from baseline and a static Physician Global Assessment (sPGA) score of 0 or 1 at week 12 was superior to placebo.

The study results showed that, compared with placebo, JS005 significantly improved the psoriasis lesion area and severity in participants. The proportion of participants achieving a static Physician Global Assessment (sPGA) score of 0 or 1 was significantly better than placebo, and it demonstrated good safety in participants with moderate to severe plaque psoriasis. The relevant research results will be announced at future international academic conferences.

References:
[1] Junshi Biosciences announces that the Phase III clinical study of JS005 (IL-17A) for the treatment of moderate to severe plaque psoriasis has met its primary endpoint. From https://www.prnasia.com/story/502420-1.shtml

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Source: Yiyao Guanlan