VFMCRP and ChemoCentryx Provide Topline Results From ACCOLADE Trial of Avacopan in C3 Glomerulopathy Including Improved Estimated Glomerular Filtration Rate (eGFR)

Regulatory News:

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Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and ChemoCentryx, Inc. today announced topline data from the ACCOLADE clinical study, the largest, randomized, blinded, placebo-controlled phase-II trial in the ultra-rare kidney disease C3 glomerulopathy (C3G) to date, which evaluated avacopan for the treatment of that disorder. Avacopan is a first-in-class, orally-administered selective inhibitor of the complement C5a receptor.

Patients in the multi-center ACCOLADE clinical trial were randomized to receive either 30mg of avacopan twice daily (BID) or placebo for 26 weeks in a double-blind manner. The primary endpoint of the study was defined as the change from baseline in the C3G histologic index for disease activity, as determined by a blinded analysis of kidney biopsies taken at baseline and after 26 weeks of blinded study treatment. Pre-specified secondary endpoints included changes in the estimated glomerular filtration rate (eGFR) (a validated measure of overall renal function), measurement of urinary protein to creatinine ratio (UPCR), measurements of urinary MCP-1 (a marker of kidney inflammation), and the C3G histologic index for disease chronicity, a biopsy based measure of the progression of renal fibrosis which is a strong predictor for progression to end stage renal disease (ESRD) in C3G. After the initial blinded treatment period, all patients receive avacopan as part of an open label extension for a further 26 weeks. Endpoint determinations from the blinded treatment period (baseline to week 26) are presented.

“We are pleased with the results of the ACCOLADE study,” said Stefan Schulze, Chief Executive Officer of Vifor Pharma. “This data set is encouraging, demonstrating important clinical benefits in patients with this C3G kidney disease in which there is currently no approved therapy. The study further consolidates the effectiveness of avacopan in proliferative glomerular diseases and confirms the evidence of the favourable safety profile of avacopan. VFMCRP will commence discussions with the European regulatory authorities about the best possible regulatory pathway to obtain approval for the European patients in this rare and otherwise inadequately treated disease.”