Apellis(US:APLS) Globenewswire·2025-12-03 22:05Core Insights - Apellis Pharmaceuticals announced positive results from the Phase 3 VALIANT study for EMPAVELI (pegcetacoplan) in treating C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), rare kidney diseases [1][4] Company Overview - Apellis Pharmaceuticals is a biopharmaceutical company focused on complement science, developing therapies for serious diseases, including the first treatment for C3G and primary IC-MPGN in patients aged 12 and older [25] Study Results - The VALIANT study demonstrated a statistically significant 68% reduction in proteinuria in EMPAVELI-treated patients compared to placebo [7] - EMPAVELI-treated patients showed stabilization of kidney function with a difference of +6.3 mL/min/1.73 m compared to placebo [7] - A majority of EMPAVELI-treated patients achieved zero C3 staining intensity, indicating complete clearance of C3 deposits [7][6] Safety Profile - The VALIANT study reported favorable safety and tolerability for EMPAVELI, with common adverse reactions including infusion site reactions, pyrexia, and nasopharyngitis [3][22] - No cases of meningococcal infection due to encapsulated bacteria were reported across over 2,750 patient-years of experience with EMPAVELI [3] Market Potential - Approximately 50% of patients with C3G and primary IC-MPGN may experience kidney failure within five to ten years of diagnosis, highlighting the urgent need for effective treatments [8] - The diseases are estimated to affect around 5,000 individuals in the U.S. and up to 8,000 in Europe, indicating a significant market opportunity for EMPAVELI [8]