Apellis and Sobi plan pegcetacoplan filing after Phase III success

9 August 2024

US biopharma Apellis Pharmaceuticals (Nasdaq: APLS) and partner Swedish Orphan Biovitrum (STO: SOBI) have announced positive topline results from the Phase III VALIANT study.

This trial is investigating the use of systemic pegcetacoplan in patients with C3 glomerulopathy (C3G) 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 C3G and IC-MPGN patients treated with pegcetacoplan compared to placebo, both in addition to background therapy, at week 26.

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