Shares of Vera Therapeutics (VERA) dropped nearly 30% in premarket trading after rival Otsuka (OTSKY) presented results from a pre-specified interim analysis of the Phase 3 VISIONARY study evaluating sibeprenlimab, for the treatment of immunoglobulin A nephropathy in adults. Patients treated with sibeprenlimab achieved a 51.2% reduction in proteinuria at nine months of treatment when compared to placebo. The data were presented during a late-breaking clinical trials session at the European Renal Association Congress in Vienna, Austria. The study, the largest Phase 3 IgAN trial conducted to date, also showed the safety profile of sibeprenlimab was favorable and consistent with previously reported data1. Specifically, 76.3% of patients treated with sibeprenlimab experienced any Treatment Emergent Adverse Event versus 84.5% in the placebo group. Patients who experienced a serious TEAE were 3.9% treated with sibeprenlimab compared to 5.4% treated with placebo. Sibeprenlimab received Priority Review designation from the FDA last month following its BLA filing in March.
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