Telitacicept meets primary endpoint in China’s phase 3 Sjögren’s trial

CAMBRIDGE, Mass. - Vor Bio (NASDAQ:VOR) announced Wednesday that its collaborator RemeGen Co., Ltd (HKEX:9995, SHA:688331) achieved the primary endpoint in a Phase 3 clinical study of telitacicept for primary Sjögren’s disease in China. RemeGen, currently valued at approximately $4.9 billion, has demonstrated impressive business fundamentals with an 81% gross profit margin and 54% revenue growth in the last twelve months, according to InvestingPro data.

The trial demonstrated that telitacicept improved disease activity as measured by a reduction in the EULAR Sjögren’s syndrome disease activity index (ESSDAI) compared to placebo. The treatment also showed a favorable safety profile, according to the company’s press release statement. This development comes as RemeGen’s stock has shown remarkable momentum, with a 118% year-to-date return, reflecting strong investor confidence in the company’s pipeline.

RemeGen plans to submit a Biologics License Application to China’s National Medical Products Administration, which would make Sjögren’s disease the fourth approved indication for telitacicept in China. The drug is already approved there for systemic lupus erythematosus, rheumatoid arthritis, and generalized myasthenia gravis.

Sjögren’s disease is a chronic autoimmune condition characterized by dry eyes and mouth, fatigue, pain, and potential systemic complications affecting multiple organs. It predominantly affects women and remains underdiagnosed, with approximately half of cases going unrecognized.

"For decades, patients with primary Sjögren’s disease have faced limited treatments options," said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of Vor Bio. "Telitacicept offers a potential option for these patients which targets the root cause of this devastating autoimmune disease."

Telitacicept is a recombinant fusion protein designed to inhibit both BLyS (BAFF) and APRIL, two cytokines involved in B cell and plasma cell survival. A global Phase 3 clinical trial for generalized myasthenia gravis is currently underway to support potential approvals in the United States, Europe, and Japan.

Detailed results from the Sjögren’s disease study are expected to be presented at an upcoming medical conference. While RemeGen shows promising clinical developments, InvestingPro analysis indicates a WEAK overall financial health score, suggesting investors should conduct thorough due diligence. InvestingPro subscribers have access to over 10 additional exclusive insights and detailed financial metrics to better evaluate investment opportunities in biotech companies.

In other recent news, Vor Biopharma Inc has entered into an exclusive licensing agreement with RemeGen Co., Ltd. for the development and commercialization of telitacicept, a dual-target fusion protein aimed at treating autoimmune diseases. This agreement grants Vor Biopharma the global rights to telitacicept, excluding China, Hong Kong, Macau, and Taiwan. As part of the deal, Vor Biopharma will make an initial payment of $125 million to RemeGen, which includes a $45 million upfront payment and $80 million in warrants for common stock. The agreement outlines potential regulatory and commercial milestones that could exceed $4 billion, along with tiered royalties. This development marks a significant step for Vor Biopharma in expanding its pipeline in the autoimmune therapy sector.

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