CHEMOCENTRYX, INC. (NASDAQ:CCXI) Files An 8-K Regulation FD Disclosure

ME Staff 8-k
-
0
CHEMOCENTRYX, INC. (NASDAQ:CCXI) Files An 8-K Regulation FD Disclosure

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:

The topline safety results revealed an acceptable safety profile in this serious and life threatening disease, with fewer subjects having serious adverse events (SAEs) in the avacopan group than in the glucocorticoid SOC control group (42% vs. 45%, respectively). Most reported SAEs were related to underlying ANCA disease and commensurate with rates in previously published ANCA trials. There were fewer subjects with serious infections in the avacopan group than the glucocorticoid SOC control group. A full analysis of the data is underway and expanded results are expected to be announced in the coming weeks.

(d) Exhibits


ChemoCentryx, Inc. Exhibit
EX-99.1 2 d839895dex991.htm EX-99.1 EX-99.1 Exhibit 99.1      ChemoCentryx and VFMCRP Announce Positive Topline Data from Pivotal Phase III ADVOCATE Trial Demonstrating Avacopan’s Superiority Over Standard of Care in ANCA-Associated Vasculitis — Achieved both primary endpoints of clinical remission at weeks 26 and 52 with statistical superiority of avacopan over standard of care (SOC) at 52 weeks — — Significantly reduced glucocorticoid toxicity — — Significantly improved kidney function compared to glucocorticoid-containing SOC — — Improved health-related quality of life measures compared to SOC — — Conference call today at 4:30 p.m. Eastern Time — MOUNTAIN VIEW,…
To view the full exhibit click here

About CHEMOCENTRYX, INC. (NASDAQ:CCXI)

ChemoCentryx, Inc. (ChemoCentryx) is a biopharmaceutical company. The Company is focused on discovering, developing and commercializing orally-administered therapeutics to treat orphan and rare diseases, autoimmune diseases, inflammatory disorders and cancer. It targets the chemoattractant system, which is a network of molecules, including chemokine ligands and their associated receptors, as well as related chemoattractant receptors. Each of its drug candidates is a small molecule designed to target a specific chemokine or chemoattractant receptor, thereby blocking the negative inflammatory or suppressive response driven by that particular receptor, while leaving the rest of the immune system intact. The Company’s pipeline comprises various programs, including orphan and rare diseases, immuno-oncology, chronic kidney disease, and other inflammatory and autoimmune diseases.