Apellis Pharmaceuticals Announces Positive Phase 3 Results for Pegcetacoplan in Rare Kidney Diseases

Details

and Sobi announced positive topline results from the Phase 3 VALIANT study for pegcetacoplan in patients with C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study demonstrated a statistically significant and clinically meaningful 68% proteinuria reduction in treated patients compared to placebo at Week 26. Pegcetacoplan also showed statistical significance on key secondary endpoints and favorable safety and tolerability results. Apellis plans to submit a supplemental new drug application to the FDA in early 2025, and Sobi plans to submit a marketing application with the EMA in 2025.

Items reported

About Apellis Pharmaceuticals Inc.

Apellis Pharmaceuticals Inc. is a biopharmaceutical company dedicated to developing novel therapeutic compounds to address complement-mediated diseases. The primary focus of Apellis is to pioneer medicines leveraging targeted inhibition of the complement system, a key component of the immune system that plays a crucial role in a variety of diseases. The company's flagship product, targeting diseases such as geographic atrophy and paroxysmal nocturnal hemoglobinuria (PNH), highlights its commitment to addressing unmet medical needs with innovative treatments. Apellis Pharmaceuticals operates in the highly competitive pharmaceutical and biotechnology industry, collaborating with healthcare providers and research institutions to advance clinical treatment options. Headquartered in Waltham, Massachusetts, its contributions to medical science are significant, paving the way for advancements in immunology and therapy development. As a publicly traded entity, Apellis influences the healthcare sector by enhancing treatment paradigms and offering new hope for patients with chronic and debilitating conditions.