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On Wednesday, Vor Bio Inc. (NASDAQ:VOR) announced that its collaborator, RemeGen Co., Ltd., achieved the primary endpoint in Stage A of a Phase 3 clinical study in China evaluating telitacicept in adults with IgA nephropathy (IgAN).
IgA nephropathy, also known as Berger’s disease, is an autoimmune kidney disease where abnormal clumps of the antibody immunoglobulin A (IgA) deposit in the kidneys’ filtering units, the glomeruli, causing inflammation and damage.
Details of the study results will be presented at an upcoming medical conference.
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“Telitacicept continues to demonstrate consistent, disease-modifying activity across autoimmune conditions, from myasthenia gravis to Sjögren’s disease and now IgA nephropathy,” said Jean-Paul Kress, M.D., Chief Executive Officer and Chairman of the Board.
The study in China enrolled 318 adult IgAN patients who had received standard therapy.
In Stage A of the Phase 3 study, telitacicept achieved the primary endpoint of reducing proteinuria, demonstrating a 55% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks compared with placebo (p<0.0001).
UPCR is an objective and globally recognized regulatory marker of disease activity in IgAN. Telitacicept demonstrated a favorable safety profile.
RemeGen announced that it 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 IgAN, which, if approved, would become telitacicept’s fifth approved indication in China.
In August, RemeGen released data from a Phase 3 clinical study in China evaluating telitacicept in adults with primary Sjögren’s disease.
The Phase 3 study in China achieved the primary endpoint of improving disease activity measured by a reduction in EULAR Sjögren’s syndrome disease activity index (ESSDAI), a comprehensive 12-domain index measuring systemic disease activity severity against placebo.
Price Action: VOR stock is trading lower by 3.37% to $2.00 at last check Wednesday.
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Posted In: VOR
