What This Study For ANCA Vasculitis Means Going Forward
ChemoCentryx, Inc. (NASDAQ: CCXI) shares more than tripled on Tuesday after the firm, in conjunction with Vifor Fresenius Medical Care Renal Pharma, announced positive topline data from its late-stage trial of avacopan for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis).
This global study of 331 patients with ANCA vasculitis 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 (BVAS).
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. 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
Importantly, subjects who received avacopan experienced additional benefits compared to those in the glucocorticoid standard of care control group. These benefits included significant reduction in glucocorticoid-related toxicity, significant improvement in kidney function in patients with renal disease, and improvements in health-related quality of life metrics.
The company plans to make regulatory submissions for full marketing approval to both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in 2020.
Thomas J. Schall, Ph.D., president and CEO of ChemoCentryx, commented:
These results exceed our expectations. 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.
Shares of ChemoCentryx were last seen up over 237% at $27.15, with a 52-week range of $6.16 to $36.88. The consensus analyst price target is $22.83.