NEWARK, Calif., Nov. 10, 2016 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ:CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for indications with high unmet medical need, including rare and orphan diseases, today announced that it will host a Key Opinion Leader breakfast on the treatment of Primary Biliary Cholangitis (PBC) at 8:00 am Eastern Time on Wednesday, November 16 in New York City.
The meeting will feature keynote presentations by renowned key opinion leaders Gideon Hirschfield, MD, Ph.D., and David Jones, MD, Ph.D., who will present an overview of PBC and the unmet needs that remain to be fulfilled for patients affected with this disease. They will also discuss results from a Phase 2 proof-of-concept study of MBX-8025 in patients with PBC that has been scheduled for late breaker presentation at this year’s Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). MBX-8025 is an orally administered potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist. The European Medicines Agency has granted CymaBay PRIority MEdicines (PRIME) status for MBX-8025 for the treatment of PBC. In addition, the FDA has recently granted MBX-8025 an orphan drug designation for the treatment of PBC.
CymaBay’s Chief Medical Officer, Pol Boudes, M.D., will also provide an overview of the company’s next Phase 2 study of MBX-8025 in PBC which is expected to initiate by the end of the year.
Dr. Hirschfield is a Senior Lecturer and Honorary Consultant Physician in the Centre for Liver Research at the University of Birmingham, UK, one of the largest such programs in Europe. Dr. Hirschfield was previously a Staff Physician and Assistant Professor of Medicine at the University Health Network and University of Toronto, where he managed one of the largest autoimmune liver disease cohorts in North America. In conjunction with his colleague Prof. Kathy Siminovitch, he published the seminal genetic observations underpinning the IL-12 signaling axis as critical to the pathophysiology of PBC. He now divides his time between translational research in autoimmune liver disease and his clinical Transplant/Hepatology practice at the Queen Elizabeth Hospital Birmingham, where he manages some of the largest international cohorts of patients with PBC, primary sclerosing cholangitis (PSC), and autoimmune hepatitis (AIH).
Dr. Jones is a Professor of Liver Immunology at Newcastle University and an Honorary Consultant Hepatologist on the Liver Transplant Unit at the Freeman Hospital. He is also Director of the Institute of Cellular Medicine in Newcastle, an innovative and multi-disciplinary research institute focused on translational research. In addition, he is Director of Clinical Fellowships in Newcastle and Director of a Wellcome Trust Interdisciplinary Training Programme in Translational Medicine and Therapeutics for Clinicians. Dr. Jones runs the largest autoimmune liver disease clinical service in the UK. He is a co-author of the European treatment guidelines for autoimmune liver disease. He also established the UK Autoimmune Liver Disease research oversight group, which brings together all of the research programmes in the UK in autoimmune liver disease (UK-PBC, UK-AIH and UK-PSC). Dr. Jones's primary research interests are in immunology and autoimmune liver disease, including primary biliary cholangitis, primary sclerosing cholangitis and autoimmune hepatitis.
The event is intended for institutional investors, sell-side analysts, and business development professionals only. If you would like to attend in person, please contact Mac MacDonald at 212-915-2567 or via e-mail at Mac@LifeSciAdvisors.com to reserve a place.
A live webcast of the event, with slides, will be available at http://lifesci.rampard.com/20161116/reg.jsp and the Investors section of the Company’s website at http://ir.cymabay.com.
About CymaBay
CymaBay Therapeutics, Inc. (CBAY) is a clinical-stage biopharmaceutical company developing therapies to treat diseases with high unmet medical need, including serious rare and orphan disorders. MBX-8025 is a potent, selective, orally active PPARδ agonist. CymaBay has recently completed a Phase 2 study of MBX-8025 in patients with primary biliary cholangitis as well as a pilot Phase 2 study in patients with homozygous familial hypercholesterolemia, establishing proof-of-concept in both indications. Previously, a Phase 2 study of MBX-8025 in patients with mixed dyslipidemia established that it has an anti-atherogenic lipid profile. Arhalofenate, CymaBay’s other product candidate, is a potential Urate-Lowering Anti-Flare Therapy that has completed five Phase 2 studies in gout patients. Arhalofenate has been found to reduce painful flares in joints while at the same time promoting excretion of uric acid by the kidney. This dual action addresses both the signs and symptoms of gout while managing the underlying pathophysiology of hyperuricemia.
Cautionary Statements
The statements in this press release, including those statements regarding the structure and conduct of clinical trials, future performance of CymaBay's product candidates, the potential of MBX-8025 to treat primary biliary cholangitis, the therapeutic and commercial potential of CymaBay’s product candidates, and any of the targeted indications for the potential future development or commercialization of CymaBay’s product candidates are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of CymaBay’s product candidates could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, risks related to: the success, cost and timing of any of CymaBay's product development activities, including clinical trials of MBX-8025 and arhalofenate; effects observed in trials to date which may not be repeated in the future; any delays or inability to obtain or maintain regulatory approval of CymaBay's product candidates in the United States or worldwide; and the ability of CymaBay to obtain sufficient financing to complete development, regulatory approval and commercialization of its product candidates in the United States and worldwide. Additional risks relating to CymaBay are contained in CymaBay's filings with the Securities and Exchange Commission, including without limitation its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. CymaBay disclaims any obligation to update these forward-looking statements except as required by law.
For additional information about CymaBay visit www.cymabay.com.