CCXI up 325% @ 34.32 > VFMCRP and ChemoCentryx Announce Positive Topline Data From Pivotal Phase-III ADVOCATE Trial Demonstrating Avacopan's Superiority Over Standard of Care in ANCA Associated Vasculitis
3:28 am ET November 26, 2019 (Benzinga) Print
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and ChemoCentryx, Inc., (NASDAQ: CCXI) today announced positive topline data from the pivotal phase-III ADVOCATE trial of avacopan, an orally administered selective complement 5a receptor inhibitor, for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis).
This global study, in which a total of 331 patients with ANCA vasculitis were enrolled, met both of its primary endpoints, disease remission at 26 weeks and sustained remission at 52 weeks, as assessed by the Birmingham Vasculitis Activity Score, or BVAS. Remission was defined as a BVAS score of zero and being off glucocorticoid treatment for ANCA vasculitis for at least the preceding four weeks.
BVAS remission at week 26 was achieved in 72.3% of the avacopan treated subjects vs. 70.1% of subjects in the glucocorticoid standard of care control group (p<0.0001 for non-inferiority). Sustained remission at 52 weeks was observed in 65.7% of the avacopan treated patients vs. 54.9% in the glucocorticoid standard of care control group, achieving both non-inferiority and superiority to glucocorticoid standard of care (p=0.0066 for superiority of avacopan).
Importantly, subjects who received avacopan experienced additional benefits compared to those in the glucocorticoid standard of care control group. These benefits, assessed as pre-specified secondary endpoints, include:
Significant reduction in glucocorticoid-related toxicity
The Glucocorticoid Toxicity Index (GTI v2) showed a significant statistical advantage in the avacopan therapy arm vs the glucocorticoid containing standard of care arm.
Significant improvement in kidney function in patients with renal disease at baseline;
Avacopan group exhibited a statistically significant improvement in estimated glomerular filtration rate (eGFR) from baseline to week 26 and also to week 52 compared to the glucocorticoid standard of care control group.
Improvements in health-related quality of life metrics
The avacopan group demonstrated statistically significant improvements in the majority of domains measured by the validated quality of life instrument SF-36 and version 2 at week 26 or 52.
The avacopan group reported statistically significantly better outcomes on the EuroQOL-5D-5L instrument.
The topline safety results revealed an acceptable safety profile in this serious and life threatening disease with fewer subjects having serious adverse events in the avacopan group than in the glucocorticoid standard of care control group. A full analysis of the data is underway and expanded results are expected to be announced in the coming weeks.
"We are delighted with the positive topline data from the phase-III ADVOCATE trial for the treatment of ANCA vasculitis," said Stefan Schulze, Vifor Pharma President of the Executive Committee and Chief Operating Officer. "By successfully meeting both primary endpoints and establishing superiority at 12 months, it confirms our belief that avacopan is a novel and better way to provide vasculitis control while reducing the risks of current standard of care and improving patient experience. This outcome is of high clinical relevance and an eagerly awaited change in the long term treatment paradigm. The result is another significant milestone in our progress towards becoming the global leader in nephrology."
"These results exceed our expectations," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "Today we mark the dawn of a new and historic period in the lives of ANCA vasculitis patients. This day we have for the first time demonstrated that a highly targeted therapy aimed at the very center of the ANCA disease process is superior to the traditional approach of broad immune suppression therapy; a therapy which the present findings may make obsolete. Until now ANCA vasculitis patients have had to endure regimens that contain chronic high doses of steroids and all their noxious effects, but with today's data it is clear that the time of making patients sick with steroid therapy in an attempt to make their acute vasculitis better may at last be over. Working with our partner VFMCRP, we plan to make regulatory submissions for full marketing approval to both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in 2020."
VFMCRP has an exclusive license to commercialize the drug in all countries outside the United States. VFMCRP has granted KISSEI PHARMACEUTICAL CO LTD., an exclusive sub-license to develop and commercialize the drug in Japan.
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