Sobi and Apellis Pharmaceuticals have reported new results from the open-label period of the randomised Phase III VALIANT trial, assessing Aspaveli (pegcetacoplan) in treating C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).
The data were showcased during a late-breaking session at the European Renal Association Congress.
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This multi-centre, double-blinded, placebo-controlled study aims to assess the efficacy and safety of pegcetacoplan in 124 subjects who are aged 12 years and above with these conditions.
Its primary endpoint was the log-transformed ratio in the urine protein-to-creatinine ratio (UPCR) at week 26 versus the baseline.
Subjects were randomised and given the therapy or placebo two times a week for 26 weeks.
After 26 weeks, the subjects were able to proceed to a 26-week open-label phase in which all of them received the therapy.
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By GlobalDataAt week 26, the therapy led to a 68% reduction in proteinuria compared to placebo, a benefit that persisted after one year.
Those who received Aspaveli’s treatment achieved kidney function stabilisation as per estimated glomerular filtration rate (eGFR) measurements.
Subjects who transitioned from placebo to the therapy in the open-label phase experienced similar improvements in proteinuria and kidney function stabilisation.
The tolerability and safety profile of Aspaveli, also known as Empaveli, remained favourable and aligned with previous findings, without any safety concerns.
C3G and primary IC-MPGN are rare kidney conditions that can result in its failure.
Sobi medical affairs and clinical development head Nils Kinnman said: “The results from the Phase III VALIANT study underscore the potential of Aspaveli in addressing the urgent needs of patients living with the kidney diseases C3G and primary IC-MPGN.”
Both companies share worldwide joint development rights for systemic pegcetacoplan, with Sobi holding exclusive rights ex-US and Apellis retaining US commercialisation rights and global rights for ophthalmological pegcetacoplan, inclusive of geographic atrophy.
Last year, the companies reported positive topline data from the same Phase III VALIANT trial assessing pegcetacoplan in treating C3G and primary IC-MPGN.
