ChemoCentryx (CCXI) Announces Presentations at Two Upcoming Medical Meetings Discussing Trials of CCX168

November 7, 2016 8:48 AM EST

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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:
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 Tesař, 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.
AAV Phase II CLASSIC Oral Presentation:
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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