Apellis to Present Positive Results from the Phase 2 DISCOVERY Study of Pegcetacoplan in C3 Glomerulopathy (C3G) at ASN Kidney Week
WALTHAM, Mass., Oct. 09, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that positive results from the Phase 2 DISCOVERY study evaluating pegcetacoplan, a targeted C3 therapy, in patients with C3 glomerulopathy (C3G) will be presented at the American Society of Nephrology (ASN) Kidney Week on October 22, 2020. The 48-week results show that patients treated with pegcetacoplan demonstrated sustained improvements across key clinical measures including a greater than 65% mean reduction in proteinuria, which is an important marker of renal damage. C3G is a rare, complement-driven kidney disease with no approved medicines.
In five C3G patients treated with pegcetacoplan, mean (SE) proteinuria decreased from 3.48 (0.82) mg/mg at baseline to 0.93 (0.27) mg/mg at week 48, a decrease of 73.3%, as measured by 24-hour urine protein-to-creatinine ratio (uPCR). Importantly, this reduction in proteinuria was accompanied by a corresponding increase in mean serum albumin. Other biomarkers improved, including an observed increase in mean serum C3 and stabilization of renal function, as measured by mean serum creatinine. No serious or severe adverse events were reported, and pegcetacoplan was well tolerated overall.
“There is an urgent need for treatments for C3G, a disease that ultimately leads to kidney failure for about half of people living with the disease. These positive results highlight the potential of pegcetacoplan to make a meaningful difference for the C3G community and further strengthen our confidence in targeting C3 across multiple complement-driven diseases,” said Federico Grossi, M.D., Ph.D., Chief Medical Officer of Apellis. “We are working quickly to progress a registrational program of our targeted C3 therapy for people living with C3G.”
Earlier this week, Apellis announced that it was advancing Phase 2 and Phase 3 studies of pegcetacoplan in patients with C3G or immune complex membranoproliferative glomerulonephritis (IC-MPGN), another rare, complement-driven kidney disease with no approved medicines.
Presentation Details at ASN Kidney Week 2020
C3 Inhibition with Pegcetacoplan Targets the Underlying Disease Process of C3 Glomerulopathy (C3G) and Improves Proteinuria, ePoster # PO1852 – Oct. 22 at 10:00 a.m. ET.
About the DISCVERY Study
The primary endpoint in the DISCOVERY study is change from baseline in proteinuria at week 48 as measured by 24-hour urine protein-to-creatinine ratios (uPCR). Secondary endpoints include analysis of serum C3 and estimated glomerular filtration rate (eGFR).
About Pegcetacoplan (APL-2)
About C3 Glomerulopathy (C3G) and Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
1 ClearView Analysis using physician and literature consensus.