Business
Apellis and Sobi Announce EMPAVELI® (pegcetacoplan) Showed Sustained Efficacy at One Year in Phase 3 Study for C3G and Primary IC-MPGN
Robust proteinuria reduction and stable kidney function were maintained across a broad population of patients No new safety signals were observedNew data
About this update from Apellis Pharmaceuticals, Inc.
[{"type":"text","content":"Robust proteinuria reduction and stable kidney function were maintained across a broad population of patients No new safety signals were observedNew data presented at late-breaking session at the European Renal Association CongressMarketing applications for EMPAVELI are under review with the FDA and EMA WALTHAM, Mass. and STOCKHOLM, June 06, 2025 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) and Sobi® (STO:SOBI) today presented new data from the open-label period of the Phase 3 VALIANT study, investigating EMPAVELI® (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). The data were presented as part of a late-breaking session at the European Renal Association (ERA) Congress. In the VALIANT study, EMPAVELI demonstrated a statistically significant 68% proteinuria reduction versus placebo at Week 26, which was sustained at one year. Additionally, patients treated with EMPAVELI continued to achieve stabilization of kidney function as measured by estimated glomerular filtration rate (eGFR). “The one-year Phase 3 results are very compelling, confirming EMPAVELI’s sustained benefits across key markers of disease,” said Fadi Fakhouri, M.D., Ph.D., presenting author, co-lead principal investigator for the VALIANT study, and professor of nephrology at CHUV Lausanne, Switzerland. “Given the high risk of kidney failure, treatment efficacy is incredibly important to C3G and primary IC-MPGN patients, many of whom are in the prime of their lives. These data further underscore the potential of EMPAVELI to make a meaningful difference for patients.” In patients who switched from placebo to EMPAVELI at the start of the open-label period, EMPAVELI demonstrated a similar magnitude of benefit in proteinuria reduction and stabilization of kidney function. “These data reinforce the strength of the EMPAVELI efficacy and safety profile across a broad population of patients with C3G and primary IC-MPGN, including adults and adolescents with native and post-transplant kidney disease,” said Peter Hillmen, M.B., Ch.B., Ph.D., chief medical advisor, rare disease, Apellis. “With an FDA decision this summer, we look forward to bringing EMPAVELI to patients living with these rare and severe kidney diseases as quickly as possible.” EMPAVELI showed favorable safety and tolera...