Vertex Reports 64% Proteinuria Reduction With Povetacicept in IgA Nephropathy Trial

Reuters
Nov 10
Vertex Reports 64% Proteinuria Reduction With Povetacicept in IgA Nephropathy Trial

Zai Lab Ltd. and Vertex have announced updated Phase 1/2 data from the RUBY-3 study evaluating povetacicept in adults with IgA nephropathy (IgAN) and primary membranous nephropathy (pMN). The 48-week results, presented at the American Society of Nephrology Kidney Week, showed a 64% decrease in proteinuria from baseline in IgAN patients and an 82% decrease in pMN patients, with stabilization of estimated glomerular filtration rate in both diseases. Vertex is planning to initiate a rolling submission of a Biologics License Application (BLA) for povetacicept for potential accelerated approval by the U.S. Food and Drug Administration (FDA) this year, following completion of full enrollment in the Phase 3 RAINIER trial for IgAN. Additionally, povetacicept has received Fast Track Designation from the FDA for pMN, and a pivotal Phase 2/3 OLYMPUS trial is underway for this indication. Further updates were discussed at an investor event, with additional information available on Vertex's website.

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