Sobi and Apellis Pharmaceuticals have announced positive topline data from the Phase III VALIANT study of pegcetacoplan in treating C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).
C3G and primary IC-MPGN are kidney diseases that could result in kidney failure.
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VALIANT is a randomised, double-blinded, placebo-controlled, multi-centre study. It aims to assess the efficacy and safety of pegcetacoplan in 124 subjects aged 12 years and above with C3G or primary IC-MPGN.
As part of the trial, participants were randomised to receive 1,080mg of pegcetacoplan or placebo two times a week for 26 weeks.
The study’s primary endpoint was the log-transformed ratio of urine protein-to-creatinine ratio (uPCR) at week 26 against baseline.
VALIANT met its primary endpoint, demonstrating a significant reduction in proteinuria in patients treated with pegcetacoplan compared to placebo.
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By GlobalDataPegcetacoplan, when added to background therapy, showed a 68% reduction in proteinuria at week 26, with consistent results across various subgroups.
The treatment also achieved statistical significance in key secondary endpoints, including a composite renal endpoint and a reduction of at least 50% in proteinuria from baseline.
The safety and tolerability profile of pegcetacoplan was favourable, with adverse event rates comparable to the placebo group.
Apellis chief development officer Jeffrey Eisele said: “These results exceeded our already high expectations. Pegcetacoplan is the first investigational therapy to show such a strong reduction in proteinuria in C3G and IC-MPGN with supportive data across multiple measures of disease activity.”
Sobi is planning to submit a marketing application to the European Medicines Agency in 2025 while Apellis aims for a supplemental new drug application to the US Food and Drug Administration early during the same year.
Pegcetacoplan is also being assessed for rare diseases across haematology and nephrology.
In May 2024, Apellis and Sobi announced positive one-year data from the Phase II NOBLE trial of pegcetacoplan in treating post-transplant recurrence of C3G and primary IC-MPGN.
