Telitacicept Achieves Primary Endpoint in Phase 3 Clinical Study for Primary Sjögren's Disease, a Novel Treatment Approach.

Vor Bio's collaborator RemeGen achieved the primary endpoint in a Phase 3 clinical study for primary Sjögren's disease with telitacicept, a dual BAFF/APRIL inhibitor. The study demonstrated a favorable safety profile and met the primary endpoint of improving disease activity measured by the EULAR Sjögren's syndrome disease activity index (ESSDAI). Telitacicept has the potential to be the best-in-disease profile in primary Sjögren's disease and RemeGen plans to submit a Biologics License Application to the Center for Drug Evaluation in China.

Vor Bio (Nasdaq: VOR) and its collaborator RemeGen Co., Ltd (HKEX: 9995, SHA: 688331) have announced significant progress in the development of telitacicept, a dual BAFF/APRIL inhibitor, for the treatment of primary Sjögren's disease. The companies reported that telitacicept achieved its primary endpoint in a Phase 3 clinical trial, demonstrating a favorable safety profile and significant improvement in disease activity as measured by the EULAR Sjögren's syndrome disease activity index (ESSDAI) [1].

The Phase 3 clinical study, conducted in China, randomized patients with primary Sjögren's disease and evaluated telitacicept's efficacy and safety over a 24-week period. The study met its primary endpoint by showing a reduction in ESSDAI scores compared to placebo, indicating a substantial improvement in disease activity. The favorable safety profile further supports telitacicept's potential as a disease-modifying therapy [2].

RemeGen plans to submit a Biologics License Application (BLA) to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China for primary Sjögren’s disease, which would make telitacicept's fourth approved indication in China. The drug's success in this trial positions it as a potential best-in-disease profile in primary Sjögren's disease, offering a significant advancement in a therapeutic area with historically limited treatment options [1].

The dual-mechanism drug, telitacicept, targets both upstream and downstream autoimmune signaling pathways, potentially offering disease-modifying benefits rather than just symptom management. This unique approach has shown promise in other autoimmune conditions, including myasthenia gravis, where telitacicept has demonstrated transformative potential [1].

For Vor Bio, this success represents a potential global expansion beyond its lead myasthenia gravis program. The company is evaluating the timing of a global Phase 3 clinical study in primary Sjögren's disease and anticipates presenting data at an upcoming medical conference [1].

The results from this trial are a significant clinical advancement, offering hope for patients with primary Sjögren's disease who have faced limited treatment options. The potential of telitacicept to modify the disease rather than just manage symptoms could set a new benchmark in the field and position the drug as a promising pipeline-in-a-product with broad applicability across multiple autoimmune diseases [1].

References:
[1] https://www.stocktitan.net/news/VOR/telitacicept-achieved-primary-endpoint-in-phase-3-clinical-study-for-eeaa27dic30z.html
[2] https://www.stocktitan.net/news/REGMY/telitacicept-meets-primary-endpoint-in-phase-iii-trial-for-primary-lbam2ucorr1z.html