cemagraphics/iStock via Getty Images Apellis Pharmaceuticals ( NASDAQ: APLS ) and partner Sobi’s experimental rare kidney disease therapy pegcetacoplan has met the primary endpoint in a Phase 3 trial . The VALIANT trial is evaluating pegcetacoplan efficacy and safety in 124 patients who are 12 years of age and older with complement 3 glomerulopathy or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), which are rare kidney diseases with no approved treatments. The study met the primary endpoint, demonstrating a statistically significant and clinically meaningful 68% proteinuria reduction in the patients treated with pegcetacoplan compared to placebo, both in addition to background therapy, at Week 26.
The therapy also achieved statistical significance on the key secondary endpoints of composite renal endpoint and showed favorable safety. Apellis ( APLS ) plans to submit a supplemental new drug application to the U.S.
Food and Drug Administration (FDA) in early 2025. Sobi plans to submit a marketing application to the European Medicines Agency in 2025. Shares of Apellis Pharmaceuticals ( APLS ) jumped 34% premarket on Thursday.
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