Apellis Pharmaceuticals and Sobi have announced positive one-year data from the Phase II NOBLE trial of pegcetacoplan in treating post-transplant recurrence of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN).
The multicentre, open-label, randomised, controlled study is designed to assess the safety and efficacy of pegcetacoplan.
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It enrolled 13 adults with post-transplant recurrence of C3G or IC-MPGN.
Participants were randomised in a 3:1 ratio to receive pegcetacoplan or maintain the standard of care for the first 12 weeks, with all patients receiving pegcetacoplan from week 13 to week 52.
The proportion of subjects with the decline in C3c staining on renal biopsy after 12 weeks of treatment with pegcetacoplan was the study’s primary goal.
Assessing safety, the proportion of subjects with the reduction in C3c staining on renal biopsy after 52 weeks of treatment and a minimum of 50% decline in proteinuria were the secondary endpoints.
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By GlobalDataThe primary endpoint was met, with a significant proportion of patients showing a reduction in C3c staining after 12 weeks.
After one year, data from 11 patients treated with pegcetacoplan revealed that 64% of the subjects experienced two or more orders of magnitude intensity reduction in C3c staining from baseline.
Furthermore, 55% of patients, including those with IC-MPGN, showed zero C3c staining intensity, suggesting clearance of C3c deposits.
Pegcetacoplan treatment resulted in 64% of patients exhibiting zero inflammation as measured by the activity score of the C3G histologic index.
Additionally, the treatment led to sustained improvements in proteinuria and kidney function stabilisation.
Pegcetacoplan was found to be well-tolerated, with most adverse events being mild to moderate in nature.
Apellis chief medical officer Caroline Baumal said: “The NOBLE data further indicate that pegcetacoplan is treating the underlying cause of these diseases by directly targeting C3.
“Our ongoing Phase III VALIANT study evaluates the potential of pegcetacoplan in all patients with these rare kidney diseases, and we look forward to sharing the topline results later this year.”
