CHEMOCENTRYX, INC. Item 7.01 Regulation FD Disclosure
On
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
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:
1. Significant reduction in glucocorticoid-related toxicity
• In the Glucocorticoid Toxicity Index (GTI version 2), the avacopan
therapy arm vs. the glucocorticoid SOC control group was statistically
significantly improved for:
• The GTI Cumulative Worsening Score: avacopan therapy 39.7 vs. 56.6
for glucocorticoid SOC (p = 0.0002 for avacopan superiority), and
for
• The GTI Aggregate Improvement Score: avacopan therapy 11.2 vs.
23.4 for glucocorticoid SOC (p = 0.0082 for avacopan superiority).
• Other measures of glucocorticoid-related adverse event assessments
(i.e., those based on EULAR -recommended adverse event terms and those
based on Investigator Assessment of causality) also showed
statistically significantly fewer events in the avacopan therapy arm
vs. the glucocorticoid SOC control group.
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2. Significant improvement in kidney function in patients with renal disease
• The 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 SOC control
group:
• Mean change from baseline to week 26 in eGFR: avacopan treated
subjects had an increase of 5.8 mL/min/1.732 vs. an increase of
2.8 mL/min/1.732 in the glucocorticoid SOC control group
(p=0.0413).
• Mean change from baseline to week 52 in eGFR: avacopan treated
subjects had an increase of 7.3 mL/min/1.732 vs. an increase in
eGFR of 4.0 mL/min/1.732 in the glucocorticoid SOC control group
(p=0.0259).
3. 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 version 2 at week 26 or 52.
• The avacopan group reported statistically significantly better
outcomes on the EuroQOL-5D-5L instrument (both Visual Analogue Scale
and EQ Index).
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.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits 99.1 Press Release Issued byChemoCentryx, Inc. , datedNovember 25, 2019 .
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements as that term
is defined in Section 27A of the Securities Act and Section 21E of the Exchange
Act. Statements in this Current Report on Form 8-K that are not purely
historical are forward-looking statements. Such forward-looking statements
include statements regarding when avacopan ANCA vasculitis NDA and MAA
regulatory filings with the FDA and EMA, respectively, will be submitted, ,
whether such regulatory submissions will be validated by the FDA and EMA, the
timing of publication or presentation of additional data from the ADVOCATE trial
and whether avacopan will be approved for full marketing approval by the FDA and
EMA. Actual results could differ from those projected in any forward-looking
statements due to numerous factors. Such factors include, among others, risks
and uncertainties in the Company's business, including those risks described in
the Company's periodic reports it files with the
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