CHEMOCENTRYX, INC. (NASDAQ:CCXI) Files An 8-K Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure
On November 25, 2019, ChemoCentryx, Inc. (the Company) and Vifor Fresenius Medical Care Renal Pharma Ltd., a company of Vifor Pharma Group, issued a press release announcing results from the pivotal Phase III trial, the ADVOCATE study, investigating avacopan, an orally administered selective complement 5a receptor inhibitor, in patients with anti-neutrophil cytoplasmic autoantibody associated vasculitis. This global study, in which a total of 331 patients with acute 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. The pre-specified primary endpoints were remission of acute vasculitis activity at week 26 and sustained remission at week 52, where avacopan therapy was at least statistically non-inferior to the currently used glucocorticoid-containing standard of care (glucocorticoid SOC). The two primary endpoints were tested sequentially using a gatekeeping procedure to preserve the Type I error.
BVAS remission at week 26 was achieved in 72.3% of the avacopan treated subjects vs. 70.1% of subjects in the glucocorticoid SOC control group (p<0.0001 for non-inferiority). Sustained remission at 52 weeks was observed in 65.7% of the avacopan treated subjects vs. 54.9% in the glucocorticoid SOC control group, achieving both non-inferiority and superiority to glucocorticoid SOC (p=0.0066 for superiority of avacopan). Reduction in overall burden of disease management and improvement in quality of life was also demonstrated through key secondary endpoints, including improved kidney function and reduction of adverse events and illnesses associated with steroids. A copy of the press release is attached to this Current Report as Exhibit 99.1 and is incorporated herein solely for purposes of this Item 7.01 disclosure.
Item 8.01 Other Events
On November 25, 2019, ChemoCentryx, Inc. (the Company) and Vifor Fresenius Medical Care Renal Pharma Ltd., a company of Vifor Pharma Group, issued a press release announcing results from the pivotal Phase III trial, the ADVOCATE study, investigating avacopan, an orally administered selective complement 5a receptor inhibitor, in patients with anti-neutrophil cytoplasmic autoantibody associated vasculitis. This global study, in which a total of 331 patients with acute 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. The pre-specified primary endpoints were remission of acute vasculitis activity at week 26 and sustained remission at week 52, where avacopan therapy was at least statistically non-inferior to the currently used glucocorticoid-containing standard of care (glucocorticoid SOC). The two primary endpoints were tested sequentially using a gatekeeping procedure to preserve the Type I error.
BVAS remission at week 26 was achieved in 72.3% of the avacopan treated subjects vs. 70.1% of subjects in the glucocorticoid SOC control group (p<0.0001 for non-inferiority). Sustained remission at 52 weeks was observed in 65.7% of the avacopan treated subjects vs. 54.9% in the glucocorticoid SOC control group, achieving both non-inferiority and superiority to glucocorticoid SOC (p=0.0066 for superiority of avacopan).
Importantly, subjects who received avacopan experienced additional benefits compared to those in the glucocorticoid SOC control group. These benefits, assessed as pre-specified secondary endpoints, include: