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The New England Journal of Medicine Publishes Positive Phase 3 VALIANT Results of pegcetacoplan for C3G and Primary IC-MPGN
Sobi® (STO:SOBI) today announced that The New England Journal of Medicine (NEJM) published positive results from the Phase 3 VALIANT study investigating pegcetacoplan for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are severe and rare kidney diseases.
About this update from Swedish Orphan Biovitrum Ab
[{"type":"list","items":[{"val":[{"type":"text","content":"Robust and clinically meaningful benefits observed across all three key markers of disease – 68% reduction in proteinuria, stabilisation of kidney function, and substantial clearance of C3 deposits. ","length":198,"tagName":"p"}]},{"val":[{"type":"text","content":"Consistent results across C3G and primary IC-MPGN, adults and adolescents, and native and post-transplant kidney disease. ","length":121,"tagName":"p"}]},{"val":[{"type":"text","content":"Pegcetacoplan is under regulatory review for the treatment of C3G and primary IC-MPGN by EMA and other regulatory bodies.","length":121,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":440,"olType":false},{"type":"text","content":"STOCKHOLM, Dec. 4, 2025 /PRNewswire/ -- Sobi® (STO:SOBI) today announced that The New England Journal of Medicine (NEJM) published positive results from the Phase 3 VALIANT study investigating pegcetacoplan for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are severe and rare kidney diseases.","length":356,"tagName":"p"},{"type":"text","content":""Pegcetacoplan has demonstrated substantial and clinically meaningful effects across all three key markers of disease: proteinuria reduction, eGFR stabilisation, and clearance of C3 deposits. Given the high risk of kidney failure, the need for dialysis and kidney transplant, these data are a welcome advance for patients with C3G and primary IC-MPGN," said Fadi Fakhouri, M.D., PhD., Professor of Nephrology from the University of Lausanne, and lead author of the manuscript.","length":486,"tagName":"p"},{"type":"text","content":"The data published in NEJM highlights the positive Phase 3 VALIANT results at Week 26, which were consistent across patients with C3G and primary IC-MPGN, adolescents and adults, and native and post-transplant kidney disease.","length":225,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Proteinuria reduction: The study met its primary endpoint, demonstrating a statistically significant 68% (p<0.0001) proteinuria reduction in pegcetacoplan-treated patients compared to placebo.","length":195,"tagName":"p"}]},{"val":[{"type":"text","content":"Stabilisation of kidney function: Pegcetacoplan-treated patients achieved stabilisation of kidney function, with ...