Apellis Pharmaceuticals, Inc. and Sobi® announced that positive results from the Phase 2 NOBLE study investigating pegcetacoplan for the treatment of post-transplant recurrence of primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G) will be presented at the American Society of Nephrology (ASN) Kidney Week Annual Meeting. he results showed the potential for a treatment effect in both IC-MPGN and C3G patients treated with pegcetacoplan. At Week 12, of the 10 patients (IC-MPGN: n=2; C3G: n=8) treated with pegcetacoplan: ight (80%) patients showed a reduction in C3c staining (reflective of damage-causing deposits) by one or more orders of magnitude of intensity from baseline.

ive (50%) patients showed a reduction in C3c staining by two or more orders of magnitude of intensity from baseline. (40%) patients showed zero staining intensity, indicating that C3c deposits were cleared. xcessive deposition of C3 breakdown products in the kidney leads to inflammation and damage of the kidney, often causing kidney failure.

dditionally, in 12 weeks, treatment with pegcetacoplan showed a mean reduction of proteinuria (39.2% change from baseline), which is a key marker of disease progression1, in a subgroup of patients with high baseline levels (=1g er day). Other biomarkers also improved, including an increase in mean serum C3, reduction in mean sC5b-9, and stabilization of kidney function as measured by estimated glomerular filtration rate (eGFR). There were no iscontinuations due to treatment-emergent adverse events.

he Phase 3 VALIANT study investigating pegcetacoplan in adolescent and adult patients with native and post-transplant recurrence IC-MPGN and C3G is ongoing with top-line results expected in 2024. fficacy of 12-week pegcetacoplan in kidney transplant recipients with recurrent C3 glomerulopathy (C3G) or immune complex membranoproliferative glomerulonephritis (IC-MPGN), Poster #SA-PO923 ? November 4, 2023 from 0:00 a.m. ?

12:00 p.m. ET.