ChemoCentryx remains on track to report topline results later this year from its ongoing Phase 3 clinical trial assessing the safety and efficacy of oral avacopan (CCX168) in patients with ANCA-associated vasculitis (AAV), the company announced.
Avacopan is an investigational inhibitor of the complement C5a receptor, and works by preventing the overactivation of the C5a complement protein. This protein is part of the complement system — a set of more than 30 blood proteins that form part of the body’s immune defenses — that is thought to be involved in the overactivation of the immune system in AAV.
After showing promising results in two previous Phase 2 trials, called CLEAR (NCT01363388) and CLASSIC (NCT02222155), avacopan is now being tested in the multi-center, randomized, double-blind, ADVOCATE Phase 3 trial (NCT02994927).
The trial has been designed to evaluate avacopan’s ability to trigger and sustain disease remission when administered in combination with Rituxan (rituximab) or cyclophosphamide, followed by azathioprine, in AAV patients. The results will be compared to those obtained by patients treated with prednisone in combination with Rituxan, or cyclophosphamide, followed by azathioprine.
The trial’s primary outcomes are the percentage of patients achieving disease remission as measured by Birmingham Vasculitis Activity Score at Week 26, and the percentage of patients achieving sustained disease remission at Week 52. Secondary outcomes will include drug safety assessments, treatment impact on health-related quality of life, and kidney function.
After announcing ADVOCATE had enrolled approximately a third of the expected 300 AAV patients, ChemoCentryx is now planning to report topline results from the trial, which will also include data from a group of patients in Japan, yielding a total of 331 study participants.
Based on the upcoming findings of ADVOCATE, the company is planning to file a full marketing authorization seeking the approval of avacopan for the treatment of AAV from the European Medicines Agency and the U.S. Food and Drug Administration.
“Achieving our ambitious objectives for 2019 is on track,” Thomas J. Schall, PhD, president and CEO of ChemoCentryx, said in a press release. “Strong positive momentum continues from 2018, and we are working toward the Q4 [fourth quarter] release of topline results from our pivotal ADVOCATE Phase 3 trial of avacopan in ANCA-associated vasculitis. We are making steady progress in our other late-stage trials as well.”
ChemoCentryx is also planning to announce topline data in 2020 from its AURORA Phase 2b trial (NCT03852472) on the effectiveness of avacopan for the treatment of patients with moderate to severe Hidradenitis Suppurativa, a chronic skin autoimmune disease.
Other Phase 2 trials — LUMINA 1 (NCT03536754) and LUMINA 2 (NCT03703908) — assessing the therapeutic effects of avacopan in patients with rare kidney disorders are currently completing patient enrollment.
“We continue our march of progress: being now another quarter closer to realizing our goal of delivering a succession of topline data, starting this year, from late-stage clinical trials,” Schall said.