NEWARK, Calif., Oct. 01, 2019 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ:CBAY) today announced that two abstracts related to its seladelpar development program for the treatment of primary biliary cholangitis (PBC) will be presented at The Liver Meeting® hosted by the American Association for the Study of Liver Diseases (AASLD) in Boston, MA (November 8-12, 2019). Seladelpar is a potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist currently in a global phase 3 registration study for the treatment of PBC (www.pbcstudies.com). Seladelpar is also being investigated in phase 2 studies for the treatment of nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC).
The presentations will include reports on clinical and pharmacokinetic data1 in PBC patients with cirrhosis. In this dataset (n=28), seladelpar exposures were comparable to non-cirrhotic PBC patients over 12 weeks. In addition, a nonclinical presentation2 will highlight seladelpar’s ethylether moiety as an important contributor to its PPARδ affinity and selectivity when compared to elafibranor, a dual PPARα/δ agonist, and its metabolite, CGF-B.
“Seladelpar is a potent PPARδ agonist that we believe is well suited as a potential therapeutic for a variety of inflammatory liver diseases,” stated Charles McWherter, Ph.D., Chief Scientific Officer at CymaBay. “With each clinical study, and with our continued efforts to further elucidate the unique characteristics of seladelpar’s structure and function, we are better prepared to advance clinical development activities that today are focused on PBC, PSC, and NASH. We believe seladelpar has the potential to significantly improve patient care and are excited to have the opportunity to present once again this year at The Liver Meeting®.”
Presentations at The Liver Meeting® 2019 include:
1“Pharmacokinetics of Seladelpar in Patients with Primary Biliary Cholangitis, with or without Cirrhosis” (Publication #1328)
Lily Mao, Christopher Bowlus, Cynthia Levy, Joseph Odin, Carmen Stanca, Palak Trivedi, Monika Varga, Sandrin Bergheanu, Ke Yang, Alexandra Steinberg, Stephen Rossi, Pol Boudes
2“Structural and Biophysical Characterization of the Origins of the Selectivity of Seladelpar and Elafibranor, Peroxisomal Proliferator Activated Receptor (PPAR) Agonists Targeting Inflammatory Liver Diseases” (Publication #2253)
Jiangao Song, Jeffrey W. Stebbins, Yun-Jung Choi, Jeffrey Johnson, Edward Cable, Charles A. McWherter
Nov 8th, 10th, 11th 12:30 pm – 1:30 pm, Hynes Convention Center, Hall B
Nov 9th 5:15 pm – 6:15 pm, Hynes Convention Center, Hall B
CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need. CymaBay’s lead development candidate, seladelpar, is a potent, selective and orally active PPARδ agonist currently in development for the treatment of patients with primary biliary cholangitis (PBC), an autoimmune liver disease, and with nonalcoholic steatohepatitis (NASH). Two Phase 2 studies of seladelpar established proof-of-concept in PBC. CymaBay is currently enrolling patients in a global, Phase 3 registration study of seladelpar for PBC. This study is a 52-week, placEbo-coNtrolled, randomized, pHAse 3 study to evaluate the safety aNd effiCacy of sEladelpar (ENHANCE) in patients with PBC. For more information about ENHANCE, please visit: www.pbcstudies.com. CymaBay is also conducting a Phase 2b proof-of-concept study of seladelpar for patients with NASH and has initiated a Phase 2 study of seladelpar for patients with primary sclerosing cholangitis (PSC).
Seladelpar is a potent, selective, orally active PPARδ agonist that is in development for the treatment of the liver diseases PBC, PSC and NASH. For PBC, seladelpar has received an orphan designation from the US Food and Drug Administration (FDA) and the European Medicine Agency (EMA). Seladelpar also received Breakthrough Therapy Designation from the FDA for early stage PBC and PRIority MEdicine status from the EMA.
Primary biliary cholangitis (PBC) is a serious and potentially life-threatening autoimmune disease of the liver characterized by impaired bile flow (cholestasis) and accumulation of toxic bile acids. There is an accompanying inflammation and destruction of the intrahepatic bile ducts, which can progress to fibrosis, cirrhosis and liver failure. Other clinical symptoms of PBC include fatigue and pruritus, which can be quite disabling in some patients. PBC is primarily a disease of women: 1 in 1000 women over the age of 40 lives with PBC.
About The Liver Meeting
The Liver Meeting® is an annual event held by the American Association for the Study of Liver Diseases (AASLD) that gathers over 9,500 hepatologists and hepatology health professionals across the nation and world. The Liver Meeting® takes place November 8-12, 2019, at the Hynes Convention Center in Boston, Massachusetts. The meeting showcases approximately 2,000 basic science and clinical posters, in addition to numerous lectures on the latest advances in liver disease research and treatment options. More information can be found at https://www.aasld.org/.
The statements in this press release regarding the potential for seladelpar to treat PBC, PSC and NASH, the potential benefits to patients, CymaBay’s expectations and plans regarding future clinical trials, including the timing of future trials, and CymaBay’s ability to fund current and planned clinical trials are forward looking statements that are subject to risks and uncertainties. Actual results and the timing of events regarding the further development of seladelpar 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; effects observed in trials to date that 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 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.
LifeSci Advisors, LLC