Sobi and Apellis exhibit positive topline outcomes from Phase III pegcetacoplan study

Sobi and Apellis Pharmaceuticals have released positive results from the Phase III VALIANT trial, evaluating pegcetacoplan for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). This double-blind, placebo-controlled study involved 124 patients aged 12 and older, who received either 1,080mg of pegcetacoplan or a placebo twice weekly for 26 weeks. The trial achieved its primary endpoint, showing a significant 68% reduction in proteinuria with pegcetacoplan compared to placebo. Key secondary endpoints, including a 50% reduction in proteinuria and a composite renal endpoint, also showed significant results. The treatment was well-tolerated, with adverse event rates similar to placebo. Sobi plans to initiate a marketing application to the European Medicines Agency (EMA) in 2025, while Apellis aims for a supplemental new drug application with the FDA. Pegcetacoplan is also being studied for other rare diseases in hematology and nephrology.