Potential OMS 721 competition, parking this Chemocentryx PR here. Original can be found on CCXI website. Not a recommendation for CCXI stock, but these are good proteinuria results. Avacopan is a complement C5a inflammatory receptor antagonist. A pretty bricky molecule, so prob some solublizing tricks with dosing, but look at the efficacy data in the abstracts, pretty good. Small molecules do have advantages over antibodies quite often.
ChemoCentryx Announces Presentations of Positive Results from Phase II ANCA-Associated Vasculitis Trials (‘CLEAR' and ‘CLASSIC') of Orally Administered Complement 5a Receptor Inhibitor CCX168 (‘Avacopan')
-- Oral presentation at the American Society of Nephrology (ASN) Kidney Week 2016 to highlight Phase II AAV CLEAR trial results --
-- Oral presentation at the American College of Rheumatology (ACR) 2016 Annual Meeting to highlight Phase II AAV CLASSIC trial results --
MOUNTAIN VIEW, Calif., Nov. 07, 2016 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq:CCXI), today announced oral presentations at two upcoming medical meetings discussing the positive results obtained from the Phase II CLEAR and CLASSIC trials of CCX168 (newly designated ‘avacopan') in patients with anti-neutrophil cytoplasmic auto-antibody (ANCA) -associated vasculitis (AAV). Avacopan is a potent orally-administered small molecule that is a selective inhibitor of the complement C5a receptor, or C5aR, and is the lead drug candidate in the Company's orphan and rare disease program.
The current standard of care in AAV uses high doses of chronic glucocorticoids (steroids such as prednisone or prednisolone), which can cause significant safety issues, including premature death. The Phase II CLEAR trial was designed to assess whether avacopan could provide highly effective control of AAV disease while also eliminating the need for steroids. Separately, the Phase II study known as CLASSIC was designed primarily as a safety study to inform eventual labeling requirements for avacopan. As previously reported, the CLEAR and CLASSIC trials both successfully met their objectives.
"The positive results from the CLEAR and CLASSIC trials mark the successful culmination of our Phase II development program with avacopan in AAV. We believe the data show strongly that avacopan, via a novel mechanism for the treatment of AAV, provides rapid and effective control of the disease. Importantly, the data also show that avacopan eliminates the need for chronic high doses of steroids currently used in the standard of care," said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. "It follows that the robust datasets to be presented at these two upcoming medical meetings support our advancing avacopan into Phase III development, which we are now preparing to do."
Presentation information is as follows:
AAV Phase II CLEAR Oral Presentation:
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| Conference:
| American Society of Nephrology (ASN) Kidney Week 2016
| Title:
| Rapid Onset of Action of Orally Administered C5aR Inhibitor CCX168 in Randomized Clinical Trial in ANCA-Associated Vasculitis (CLEAR)
| Presenter:
| Prof. Vladimír Tesar, MD, PhD, MBA, FASN, Department of Nephrology, Charles University and Principal Investigator of the CLEAR trial
| Session:
| CKD and AKI Clinical Trials
| Date & Time:
| Thursday, 11/17/2016, Presentation Start Time: 5:42 PM. CT
| Location:
| Session room S103, McCormick Place, Chicago, IL.
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| AAV Phase II CLASSIC Oral Presentation:
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| Conference:
| American College of Rheumatology (ACR) 2016 Annual Meeting
| Title:
| A Randomized Clinical Trial of CCX168, an Orally Administered C5aR Inhibitor for Treatment of Patients with ANCA-Associated Vasculitis
| Presenter:
| Dr. Peter A. Merkel, Chief of Rheumatology and Professor of Medicine at the University of Pennsylvania
| Session:
| Vasculitis I: Novel Approaches to Therapy
| Date & Time:
| Sunday, November 13, 2016, 3:15 PM - 3:30 PM CT
| Location:
| Walter E. Washington Convention Center, Washington, D.C.
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About CCX168 (avacopan)
CCX168 (avacopan) is an orally-administered small molecule that is a selective inhibitor of the complement C5a receptor, or C5aR, and is the lead drug candidate in the Company's orphan and rare disease program. The U.S. Food and Drug Administration granted orphan-drug designation for avacopan for the treatment of patients with AAV, (which includes Wegener's granulomatosis, microscopic polyangiitis, and Churg-Strauss syndrome) and also for the treatment of patients with atypical hemolytic uremic syndrome (aHUS). The European Commission has granted orphan medicinal product designation for avacopan for the treatment of microscopic polyangiitis and granulomatosis with polyangiitis (formerly known as Wegener's granulomatosis). Both conditions are forms of AAV. Avacopan was also granted access to the European Medicines Agency's (EMA) PRIority MEdicines (PRIME) initiative, which supports accelerated assessment of investigational therapies addressing unmet medical need.
About ANCA-Associated Vasculitis |
