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Vertex Announces Positive Week 36 Interim Analysis Results for Primary and All Secondary Endpoints in the RAINIER Phase 3 Trial of Povetacicept in Adults With IgA Nephropathy
- For the primary endpoint, patients treated with povetacicept achieved a 52.0% reduction from ...
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[{"type":"text","content":"Vertex Announces Positive Week 36 Interim Analysis Results for Primary and All Secondary Endpoints in the RAINIER Phase 3 Trial of Povetacicept in Adults With IgA Nephropathy\n\n\n .bwalignc { text-align: center; list-style-position: inside }\n.bwblockalignl { margin-left: 0px; margin-right: auto }\n.bwcellpmargin { margin-bottom: 0px; margin-top: 0px }\n.bwleftsingle { border-left: solid black 1pt }\n.bwpadb3 { padding-bottom: 4px }\n.bwpadl0 { padding-left: 0px }\n.bwpadr0 { padding-right: 0px }\n.bwrightsingle { border-right: solid black 1pt }\n.bwrowaltcolor1 { background-color: #d3d3d3 }\n.bwsinglebottom { border-bottom: solid black 1pt }\n.bwtablemarginb { margin-bottom: 10px }\n.bwtopsingle { border-top: solid black 1pt }\n.bwvertalignm { vertical-align: middle }\n.bwwidth100 { width: 100% }\n.bwwidth25 { width: 25% }\n.bwwidth50 { width: 50% }\n \n\n\n\n -\n \n For the primary endpoint, patients treated with povetacicept achieved a 52.0% reduction from baseline in proteinuria as measured by 24-hour urine protein to creatinine ratio (UPCR) and achieved a statistically significant and clinically meaningful 49.8% reduction in UPCR versus placebo (P<\n \n 0.0001\n \n ) –\n \n\n\n -\n \n For the first secondary endpoint, povetacicept treatment led to a 77.4% reduction from baseline in serum Gd-IgA1, resulting in a statistically significant and clinically meaningful reduction of 79.3% (P<\n \n 0.0001\n \n ) versus placebo; for the second secondary endpoint, 85.1% of povetacicept-treated patients achieved hematuria resolution, resulting in a statistically significant and clinically meaningful improvement of 61.7% (P<\n \n 0.0001\n \n ) versus placebo –\n \n\n\n -\n \n Povetacicept was generally safe and well tolerated –\n \n\n\n -\n \n Vertex to complete Biologics License Application by the end of March for potential U.S. Accelerated Approval –\n \n\n\n\n\n\n Vertex Pharmaceuticals Incorporated\n \n (Nasdaq: VRTX) today announced positive data from a pre-specified Week 36 interim analysis of the ongoing Phase 3 RAINIER trial of povetacicept, an engineered fusion protein and dual inhibitor of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, in immunoglobulin A nephropathy (IgAN).\n \n\n This press release features multimedia. View the full release her...