Swedish Orphan Biovitrum AB (Sobi) will present longer-term kidney data at a Denver meeting, where abstracts report lower proteinuria among patients receiving Aspaveli/Empaveli (pegcetacoplan) but provide no placebo comparison for the 76-week follow-up.
Sobi said seven abstracts on the drug were accepted for the American Society of Nephrology (ASN) Kidney Week meeting, scheduled for Oct. 21-25. Two oral presentations cover patients with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN).
ASN’s overall abstract lists 120 patients in an interim analysis involving the two diseases. It reports a 64.1% geometric mean reduction in proteinuria at week 76, but does not state how many patients contributed measurements at that point. The least-squares mean change in estimated glomerular filtration rate (eGFR), a measure of kidney function, was −1.4 mL/min/1.73 m². In a subgroup of 23 patients with greater kidney scarring at baseline, the least-squares mean change was −11.0 mL/min/1.73 m². The abstract reported no new safety signals.
A separate abstract covers 53 adolescents treated through week 76. It reports a 67.5% geometric mean reduction in proteinuria and a least-squares mean eGFR increase of 8.4 mL/min/1.73 m².
The U.S. Food and Drug Administration (FDA) label reports that, during VALIANT’s 26-week placebo-controlled phase, Empaveli produced a 68% greater reduction from baseline in urine protein-to-creatinine ratio than placebo. The longer follow-up includes an open-label extension without a concurrent placebo group, so its changes from baseline do not establish the drug’s comparative benefit through week 76.
For U.S. patients aged 12 and older with C3G or primary IC-MPGN, the FDA lists Empaveli as a treatment to reduce proteinuria and loss of kidney function. Its boxed warning concerns serious infections caused by encapsulated bacteria. The abstracts list Sobi and Apellis Pharmaceuticals as funders; Sobi holds commercial rights outside the United States, while Apellis holds U.S. rights.
Two posters describe ongoing studies rather than results: PRISM-C3 is gathering treatment data outside the United States, and PRESERVE-C3Tx expects to begin recruiting kidney transplant recipients by the end of 2026. The adolescent findings are scheduled for presentation Oct. 22, followed by the overall analysis on Oct. 24.
