RemeGen Achieves Primary Endpoint in Phase 3 Study for Telitacicept in Primary Sjgren's Disease

Vor Bio's collaborator RemeGen achieved the primary endpoint in a Phase 3 study evaluating telitacicept in Chinese adults with primary Sjogren's disease. The study showed a reduction in EULAR Sjogren's syndrome disease activity index, indicating improved disease activity. Telitacicept also demonstrated a favorable safety profile. RemeGen plans to submit a Biologics License Application to the Chinese regulatory agency.

Vor Bio's (Nasdaq: VOR) collaborator, RemeGen Co., Ltd., has successfully achieved the primary endpoint in a Phase 3 clinical study evaluating telitacicept in Chinese adults with primary Sjögren's disease. The study, conducted in China, demonstrated a significant reduction in the EULAR Sjögren's syndrome disease activity index (ESSDAI), indicating improved disease activity. Telitacicept also exhibited a favorable safety profile, further enhancing its clinical potential.

RemeGen plans to submit a Biologics License Application (BLA) to the Chinese regulatory agency, which would make telitacicept the company's fourth approved indication in China. The dual BAFF/APRIL inhibitor targets both upstream and downstream autoimmune signaling pathways, potentially offering disease-modifying benefits rather than just symptom management. This unique dual-targeting approach represents a paradigm shift in Sjögren's treatment.

The successful Phase 3 results for telitacicept in primary Sjögren's disease signify a significant clinical advancement in a therapeutic area with historically limited treatment options. Details of the study results are anticipated to be presented at an upcoming medical conference.

Vor Bio, a clinical-stage biotechnology company focused on transforming the treatment of autoimmune diseases, continues to advance telitacicept through Phase 3 clinical development and commercialization. The company's success with telitacicept positions it as a potential pipeline-in-a-product with broad applicability across multiple autoimmune diseases.

References:

[1] https://www.morningstar.com/news/globe-newswire/9511666/telitacicept-achieved-primary-endpoint-in-phase-3-clinical-study-for-primary-sjgrens-disease-with-telitacicept-a-dual-baffapril-inhibitor
[2] https://www.stocktitan.net/news/VOR/telitacicept-achieved-primary-endpoint-in-phase-3-clinical-study-for-eeaa27dic30z.html