After the U.S. markets closed yesterday, ChemoCentryx Inc. (CCXI:NASDAQ), a Mountain View, Calif.-based developer of new medications targeted at inflammatory and autoimmune diseases and cancer, and its Switzerland-based partner Vifor Fresenius Medical Care Renal Pharma (VFMCRP), part of the Vifor Pharma Group (CH0364749348:SIX Swiss Exchange), announced positive topline data from the pivotal Phase 3 ADVOCATE trial of avacopan for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis).
The company notes that "avacopan is a first-in-class, orally-administered molecule that employs a novel, highly targeted mode of action in the treatment of ANCA-associated vasculitis and other complement-driven autoimmune and inflammatory diseases." The firm notes that it owns and retains the commercial rights to avacopan in the U.S. and that VFMCRP has an exclusive license to commercialize the drug in all countries outside the U.S.
The ADVOCATE trial of avacopan was a 52-week global randomized, double-blind Phase 3 trial of 331 patients in 20 countries with ANCA-associated vasculitis. The pre-specified primary endpoints, which were successfully met in the trial, were remission of acute vasculitis activity at week 26 and sustained remission at week 52. The company highlighted that subjects who received avacopan also experienced 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.
David Jayne, director of the Vasculitis and Lupus Clinic at Addenbrooke's Hospital, Cambridge, commented, "This is the transformational result that clinicians and patients all over the world had been hoping for...The ADVOCATE trial demonstrated clearly that avacopan effectively brought patients into a state of remission for their acute vasculitis symptoms and kept them there for the entire period of this study. Importantly, avacopan did this in the absence of the traditional sustained daily steroid therapy that is the current standard of care and against which avacopan was compared...The notable and significant improvements in quality of life, the reductions in overall glucocorticoid toxicities and especially the improvements in renal function with avacopan therapy when compared to the steroid-containing standard of care are remarkable...In addition to changing the landscape of ANCA vasculitis therapy, these results have ramifications for other inflammatory diseases beyond ANCA vasculitis."
ChemoCentryx's President and CEO Thomas J. Schall, Ph.D., remarked, "These results exceed our expectations...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...Working with our partner VFMCRP, we plan to make regulatory submissions for full marketing approval to both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in 2020."
Stefan Schulze, Vifor Pharma's president of the Executive Committee and COO, added, "We are delighted with the positive topline data from the Phase 3 ADVOCATE trial for the treatment of ANCA vasculitis...By successfully meeting both primary endpoints and establishing superiority at 12 months, it confirms our belief that avacopan is a novel and better way to provide vasculitis control while reducing the risks of current standard of care and improving patient experience. This outcome is of high clinical relevance and an eagerly awaited change in the long-term treatment paradigm."
The company explains that "ANCA vasculitis is a systemic disease in which over-activation of the complement pathway further activates neutrophils, leading to inflammation and destruction of small blood vessels. This results in organ damage and failure, with the kidney as the major target, and is fatal if not treated."
ChemoCentryx's partner Vifor Pharma Group is headquartered in Switzerland and is a global specialty pharmaceuticals company focused on iron deficiency, nephrology and cardio-renal therapies. Vifor Pharma Group companies include Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, Relypsa and OM Pharma.
ChemoCentryx is a biopharmaceutical company developing new medications targeted at inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally-administered therapies. ChemoCentryx is currently focusing on its late stage drug candidates for patients with rare diseases, avacopan (CCX168) and CCX140. CCX140 is currently being developed for patients with focal segmental glomerulosclerosis (FSGS), a debilitating kidney disease.
ChemoCentryx ended the trading day yesterday with a market capitalization of approximately $469.6 million with about 58.27 million shares outstanding along with a short interest of around 5.6%. CCXI shares opened greatly higher today at $34.82 (+26.76, +332.01%) over yesterday's closing price of $8.06. The stock set a new 52-week high price this morning of $36.88/share and has traded today between $26.74 to $36.88 per share. The company's shares closed at $30.73 (+22.67, +281.27%).[NLINSERT]
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