ChemoCentryx Inc CCXI shares were ripping higher Tuesday following a clinical readout.
ChemoCentryx Releases Avacopan Data
ChemoCentryx and its licensing partner Vifor Fresenius Medical Care Renal Pharma announced positive top-line data Monday from the pivotal Phase 3 ADVOCATE study of avacopan for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis, or ANCA vasculitis.
ANCA vasculitis is a condition in which neutrophils — a type of white blood cells that increase in response to infections, injuries and stress — attack small blood vessels of organs, primarily the kidney, and eventually cause organ damage.
Avacopan is an orally administered selective complement 5a receptor inhibitor.
ADVOCATE, a global study that evaluated 331 patients, met the primary endpoints of remission at 26 weeks and sustained remission at 52 weeks, as measured by the Birmingham Vasculitis Activity Score, or BVAS.
For both primary endpoints, avacopan was found at least statistically non-inferior to the currently used glucocorticoid-containing standard-of-care, or SOC.
BVAS remission at week 26 was achieved in 72.3% of avacopan-treated subjects versus 70.1% for the SOC control group, and sustained remission at 52 weeks was observed in 65.7% of avacopan-treated subjects compared to 54.9% for the SOC control group.
ChemoCentryx also noted other additional benefits compared to the glucocorticoid SOC control group, including a significant reduction in glucocorticoid-related toxicity, a significant improvement in kidney function in patients with renal disease and improvements in health-related quality of life metrics.
Additionally, top-line safety results revealed an acceptable safety profile, the company said.
The company announced Tuesday that it will present Dec. 4 at the 31st Annual Piper Jaffray Healthcare Conference.
CEO: Avacopan Results 'Exceed Our Expectations'
Avacopan in ANCA-associated vasculitis is ChemoCentryx's most advanced clinical program.
The pipeline asset achieved remission in patients without the use of traditional sustained daily steroid therapy, which is the current SOC the drug was compared with.
"These results exceed our expectations," CEO Thomas Schall said in a statement.
"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."
ChemoCentryx said it plans to make regulatory submissions in the U.S. and Europe in 2020.
The stock was trading 303.85% higher at $32.55 at the time of publication Tuesday.
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