STOCKHOLM, Oct. 27, 2024 /PRNewswire/ -- Sobi® (STO: SOBI) and Apellis Pharmaceuticals, Inc. today announced that detailed data from the phase 3 VALIANT study were presented as an oral presentation during the High-Impact Clinical Trials session at the 2024 American Society of Nephrology (ASN) Kidney Week.
The results highlighted the potential of systemic pegcetacoplan treatment in patients with C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are rare, debilitating kidney diseases. "Pegcetacoplan is the only treatment to achieve substantial and clinically meaningful effects across all key markers of disease: proteinuria, eGFR stabilisation, and C3c staining," said Carla Nester, M.D.
MSA, FASN, lead principal investigator for the VALIANT study, professor of internal medicine and paediatrics, and director of paediatric nephrology, University of Iowa Stead Family Children's Hospital. "C3G and primary IC-MPGN often affect patients as early as adolescence, often leading to either a kidney transplant or lifelong dialysis, so there is an urgent need for an approved treatment that can prolong kidney function." Statistically significant 68% proteinuria reduction across a broad study population, with reduction observed as early as Week 4 Pegcetacoplan-treated patients showed a statistically significant and clinically meaningful 68.
1% (p<0.0001) proteinuria reduction (log-transformed ratio of urine protein-to-creatinine ratio).