MOUNTAIN VIEW, Calif., Oct. 17, 2016 (GLOBE NEWSWIRE) — ChemoCentryx, Inc., (Nasdaq:CCXI), today announced that positive data from an ongoing Phase II proof-of-concept study of CCX168 for the treatment of Atypical Hemolytic Uremic Syndrome (aHUS) will be presented at the American Society of Nephrology (ASN) Kidney Week 2016 Annual Meeting. CCX168 (newly designated “avacopan”) is an orally-administered small molecule that is a selective inhibitor of the complement C5a receptor, or C5aR. CCX168 (avacopan) is a lead drug candidate in the Company’s orphan and rare disease program.
The data to be presented are from the Company’s ongoing open-label clinical study designed to assess the effects of orally-administered CCX168 on thrombus formation ex vivo from aHUS patients with end-stage renal disease. The aHUS patients in the study are on stable chronic hemodialysis or peritoneal dialysis and CCX168 (avacopan) treatment to these patients comprised administration of the agent at 30 mg twice daily for two weeks. Five patients have been treated to date. Highlights from the presentation will include the following:
- After 14 days of dosing in aHUS patients, the mean decrease in thrombus size was 83%. Three patients showed 100% inhibition of thrombus formation and one patient showed >30% inhibition. Additionally, one patient who received only two days of treatment showed >30% inhibition at that time.
- Treatment appeared to be mechanism specific: when CCX168 treatment was stopped, the thrombus size returned to baseline levels.
- Not unexpectedly, serum C3, C4, and plasma C5b-9 levels were unchanged with CCX168 treatment.
- There was one SAE, not considered related to CCX168 use, in a patient with long-standing cardiovascular and renal disease of cardiac asystole.
- Patients with aHUS often have low platelet counts due to high thrombotic activity. Two patients in the study had low platelet counts which increased on CCX168 treatment (163 to 223/μL and 152 to 196/μL).
“Atypical hemolytic uremic syndrome, or aHUS, is a rare, life-threatening disease characterized by systemic thrombotic microangiopathy (TMA), or the formation of blood clots in small blood vessels, throughout the body,” said Giuseppe Remuzzi, M.D., F.R.C.P., Head of Nephrology and Dialysis and Chairman of the Department of Transplantation at Bergamo Hospital and Research Coordinator of Mario Negri Institute for Pharmacological Research in Bergamo, Italy. “We are especially encouraged to find that with CCX168 treatment a complete inhibition of thrombus formation induced by the serum of three aHUS patients on microvascular endothelium, as well as partial inhibition in the other two patients evaluated to date. This is particularly important, as systemic TMA can lead to heart attack, stroke, and kidney failure, which are the primary causes of mortality associated with aHUS.”
“People with aHUS have a lifelong risk of having this devastating condition suddenly become active. We believe that inhibition of the C5a receptor by CCX168 represents a potential solution to preventing ischemic end-organ damage in these patients,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer, ChemoCentryx. “We look forward to initiating a multi-center clinical trial in patients with aHUS in 2017.”
The results will be presented in a poster titled, “Orally Administered Complement 5a Receptor Inhibitor CCX168 Shows Ex Vivo Anti-Thrombogenic Activity in a Phase 2 Study in End-Stage Renal Disease Patients with Atypical Hemolytic Uremic Syndrome (ACCESS Study) (Abstract #1975, November 17, 10:00 to 2:00 p.m. CT, Session: CKD: Clinical Trials).
Other company presentations at ASN Kidney Week 2016 include:
|Oral:||Rapid Onset of Action of Orally Administered C5aR Inhibitor CCX168 in Randomized Clinical Trial in ANCA-Associated Vasculitis (CLEAR) Abstract Program #TH-OR037|
|Presenter:||Dr. David Jayne, Director, Vasculitis and Lupus Clinic, the University of Cambridge, UK and Principal Investigator of the CLEAR trial|
|Session:||CKD and AKI Clinical Trials|
|Date & Time:||Thursday, 11/17/2016, 4:30 PM – 6:30 PM CT|
|Poster:||Creation of Complement Factor H Mutations in human C5a-Receptor Knock-in Mice as a Model to Assess the Effects of C5aR Antagonism in Complement-Mediated Renal Diseases (Abstract #1945)|
|Presenter:||Chris Li, Senior Scientist, ChemoCentryx|
|Session:||Genetic Epidemiology and Other Genetic Studies of Common Kidney Diseases|
|Date & Time:||Friday, 11/18/2016, 10:00 AM – 12:00 PM CT|
The abstracts can be accessed through the ASN Kidney Week 2016 website. Following the meeting, copies of the posters can be obtained by contacting the Company.
ChemoCentryx, Inc. is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing orally-administered therapeutics that target the chemokine and chemoattractant systems in order to treat autoimmune diseases, inflammatory disorders and cancer. The chemokine system is a biological network that regulates inflammation via a collection of secreted chemokine molecules, or ligands, and their specific cell surface receptors. Based on its proprietary drug discovery and drug development platform, ChemoCentryx has generated multiple clinical and preclinical-stage programs, each targeting distinct chemokine and chemoattractant receptors with different small molecule compounds. CCX168 (avacopan), a C5aR inhibitor, is in Phase II development for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). CCX168 appears to be safe, well tolerated and successful in allowing reduction and elimination of high-dose steroids, part of standard of care for AAV patients, without compromising efficacy or safety in clinical studies to date. CCX168 is also in Phase II studies for the treatment of atypical hemolytic uremic syndrome (aHUS) and immunoglobulin A nephropathy, or IgA nephropathy (IgAN). ChemoCentryx has licensed exclusive rights to Vifor Pharma to commercialize CCX168 in Europe and certain other markets outside of the U.S. and most of Asia. CCX872, a CCR2 inhibitor, successfully completed Phase I development and is conducting a Phase Ib study for the treatment of non-resectable pancreatic cancer. CCX140, a distinct CCR2 inhibitor, successfully completed a Phase II clinical trial where it was shown to be safe and well tolerated while demonstrating statistically significant improvement in albuminuria in patients with diabetic nephropathy. Other clinical programs include CCX507, a next generation CCR9 inhibitor, which has successfully completed Phase I development, vercirnon (also known as Traficet-EN or CCX282) a specific CCR9 inhibitor for the treatment of inflammatory bowel disease, and CCX354, a CCR1 inhibitor which successfully completed a Phase II clinical trial for the treatment of rheumatoid arthritis. ChemoCentryx also has several programs in advanced preclinical development.
ChemoCentryx cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential,” “continue” or “project” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company’s statements regarding timing of initiating a multi-center clinical trial in aHUS for CCX168 and whether CCX168 will be shown to be effective in the treatment of aHUS and other orphan and rare diseases. The inclusion of forward-looking statements should not be regarded as a representation by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in the ChemoCentryx business and other risks described in the Company’s filings with the Securities and Exchange Commission (“SEC”). Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in ChemoCentryx’s periodic reports filed with the SEC, including ChemoCentryx’s Annual Report on Form 10-K filed with the SEC March 14, 2016 and its other reports which are available from the SEC’s website (www.sec.gov) and on ChemoCentryx’s website (www.chemocentryx.com) under the heading “Investors.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Source: ChemoCentryx (CCXI-G)
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