A late-stage clinical study in China conducted by Vor Bio’s collaborator RemeGen Co., which is evaluating Telitacicept in adults with primary Sjögren’s disease, achieved the primary endpoint of improving disease activity compared to placebo.
Vor Bio (VOR) announced on Wednesday that its collaborator, RemeGen Co., achieved the primary goal in a late-stage study in China evaluating Telitacicept in adults with primary Sjögren’s disease.
Shares of VOR jumped 19% in morning trade at the time of writing. On Stocktwits, retail sentiment around Vor Bio jumped from ‘bearish’ to ‘extremely bullish’ over the past 24 hours, while message volume rose from ‘extremely low’ to ‘high’ levels.
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The late-stage clinical study in China achieved the primary endpoint of improving disease activity measured by a reduction in EULAR Sjögren’s syndrome disease activity index (ESSDAI), compared to placebo, the company said. Telitacicept also demonstrated a favorable safety profile in the study, it added.
RemeGen now 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. If approved, primary Sjögren’s disease will become Telitacicept’s fourth approved indication in China after systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG), Vor Bio noted.
Sjögren’s disease is a chronic autoimmune condition in which overactive B cells drive inflammation, damaging moisture-producing glands and, in many cases, other organs. Symptoms include dry eyes and dry mouth, alongside fatigue, pain, and systemic complications affecting the skin, lungs, kidneys, and nervous system.
“Sjögren’s represents a significant global expansion opportunity for Vor beyond myasthenia gravis, further extending the reach and impact of our portfolio,” said Vor Bio CEO Jean-Paul Kress.
Vor Bio and Remegen entered into an exclusive license agreement granting Vor Bio the global rights to develop and commercialize Telitacicept, excluding China, Hong Kong, Macau, and Taiwan, in June. On Wednesday, the company said that it is evaluating the timing of a global late-stage study of the drug in primary Sjögren’s disease.
VOR stock is up by 78% this year and by 138% over the past 12 months.
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