Phase 3 results for pegcetacoplan show reduced proteinuria, stabilized eGFR vs. placebo
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Key takeaways:
- Sobi and Apellis Pharmaceuticals Inc. announced positive results from the phase 3 Valiant study of pegcetacoplan.
- The drug demonstrated statistical significance in reducing proteinuria and stabilizing eGFR.
Sobi and Apellis Pharmaceuticals Inc. announced results from the phase 3 Valiant study showing the drug pegcetacoplan reduced proteinuria and stabilized eGFR compared to placebo in patients with glomerulopathy or glomerulonephritis.
“The study met the primary endpoint, demonstrating a statistically significant and clinically meaningful 68% (P < .0001) proteinuria reduction (log-transformed ratio of urine protein-to-creatinine ratio) in [C3 glomerulopathy] C3G and [primary immune complex membranoproliferative glomerulonephritis] IC-MPGN patients treated with pegcetacoplan compared to placebo, both in addition to background therapy, at week 26,” according to a press release from the company. “Results were consistent across all subgroups including C3G and IC-MPGN, adolescent and adult patients, and native and post-transplant kidneys.”
Pegcetacoplan also demonstrated statistical significance on the composite renal endpoint, which combines proteinuria reduction of at least 50% compared to baseline and eGFR stabilization.
“As a clinician, I’m thrilled by these groundbreaking results, which show that pegcetacoplan has the potential to significantly improve the lives of patients with C3G and IC-MPGN, regardless of disease type, age, and transplant status,” Carla Nester, MD, MSA, FASN, lead principal investigator for the Valiant study, said in the release. “Currently, many patients living with these rare diseases will eventually require a kidney transplant or lifelong dialysis, so there is an urgent need for a treatment that targets the underlying cause of these diseases. These positive data are a major advance for the rare kidney disease community.”
“These results exceeded our already high expectations,” Jeffrey Eisele, PhD, chief development officer at Apellis, said in the release. “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,” he said. “Building on pegcetacoplan’s approval in [paroxysmal nocturnal hemoglobinuria] PNH, we look forward to sharing these data with the FDA and working quickly to bring this treatment to patients with these debilitating kidney diseases.”
The phase 3 trial demonstrated favorable safety and tolerability, according to the release. Rates of adverse events leading to study drug discontinuation were similar between the pegcetacoplan and placebo groups, the company noted.
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