A featured presentation will highlight final results from a 1-year, open-label Phase 2 study of seladelpar in primary biliary cholangitis (PBC)
NEWARK, Calif., Aug. 20, 2020 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on developing and providing access to innovative therapies for patients with liver and other chronic diseases, today announced that two seladelpar presentations will be delivered during the Digital International Liver Congress™ 2020 of the European Association for the Study of Liver (EASL) which will be held online August 27th – 29th.
The presentation titled “Durability of treatment response after 1 year of therapy with seladelpar in patients with primary biliary cholangitis (PBC): final results of an international phase 2 study,”1 will be delivered by Dr. Cynthia Levy, MD, Associate Professor of Medicine, University of Miami. This electronic presentation will highlight the efficacy, safety, and tolerability of seladelpar treatment over 1 year.
In addition, a preclinical oral presentation2 will highlight the effects of seladelpar in a mouse model of ethanol-induced liver disease from Professor Bernd Schnabl and collaborators at the University of California, San Diego.
Sujal Shah, CEO and President of CymaBay Therapeutics, commented, “We are excited to share the final results from an open-label Phase 2 study of seladelpar in PBC. The data demonstrate that seladelpar retained efficacy and appeared safe and tolerable after 1 year of treatment in patients with PBC. We believe the observed response in this study along with recently reported data from the placebo-controlled ENHANCE study support the evaluation of seladelpar in a new Phase 3 registration study in PBC. We want to extend our sincere gratitude to the patients who have participated in our clinical studies, their families, and the investigators and clinical research team members that support them.”
August 27th 12:30 PM CEST
1“Durability of treatment response after 1 year of therapy with seladelpar in patients with primary biliary cholangitis (PBC): final results of an international phase 2 study”
Cynthia Levy, Christopher Bowlus, Guy Neff, Mark G. Swain, Michael Galambos, Marlyn J. Mayo, Aparna Goel, Palak Trivedi, Gideon Hirschfield, Richard Aspinall, Andreas E. Kremer, Stuart C. Gordon, Brian Borg, Stephen Harrison, David Jones, Paul Thuluvath, Yvonne Doerffel, Carmen Stanca, David Sheridan, Bruce Bacon, Christoph Berg, Douglas Thorburn, John Vierling, Mitchell Shiffman, Joseph Odin, Tarek Hassanein, Adam Peyton, Aliya Gulamhusein, Charles Landis, David Bernstein, Lynsey Corless, Marcus-Alexander Woerns, Peter Buggisch, Sandrin Bergheanu, Wendy Chen, Frances Seput-Dingle, Lily Mao, Yu Li, Ke Yang, Elena Muslimova, Yun-Jung Choi, Monika Varga, Klara Dickinson, Pol Boudes, Charles McWherter, Alexandra (Sasha) Steinberg
August 27th 12:00 – 12:15 PM CEST
2“The selective PPAR-delta agonist seladelpar reduces ethanol-induced liver disease by restoring gut barrier function and bile acid homeostasis in mice”
Huikuan Chu, Bei Gao, Yanhan Wang, Lu Jiang, Edward Cable, Bernd Schnabl
A full list of presentations can be found on The Digital International Liver Congress™ 2020 website.
The presentations will also be made available on the CymaBay website.
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.
Seladelpar is a potent, selective, orally active PPARδ agonist that has been in development for the treatment of the liver diseases PBC and nonalcoholic steatohepatitis (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 and PRIority MEdicine status from the EMA for PBC.
CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need.
The statements in this press release regarding the potential for seladelpar to treat PBC and potentially improve clinical symptoms of the disease, the potential benefits to patients, CymaBay’s expectations and plans regarding its intended future interactions with the FDA, its current and future clinical 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 or to potentially restart clinical trials. 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.
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