CymaBay Therapeutics, Inc. (NASDAQ: CBAY) today announced that a late-breaking presentation highlighting results from the RESPONSE Phase 3 study of seladelpar in patients with primary biliary cholangitis (PBC) will be presented at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD), in Boston, MA (November 10th – 14th).
Results from the RESPONSE registrational study to be highlighted in oral presentation on Monday, November 13th
Fifth oral late-breaking presentation of seladelpar results at The Liver Meeting®
NEWARK, Calif., Oct. 18, 2023 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that a late-breaking presentation highlighting results from the RESPONSE Phase 3 study of seladelpar in patients with primary biliary cholangitis (PBC) will be presented at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD), in Boston, MA (November 10th – 14th). Seladelpar is a potent, selective, orally active delpar or PPARδ agonist, in development for the treatment of adult patients with primary biliary cholangitis (PBC).
The oral presentation titled “Efficacy and Safety of Seladelpar in Patients with Primary Biliary Cholangitis in the RESPONSE Trial: A Phase 3 International, Randomized, Placebo-Controlled Study,”1 will be delivered by Professor Gideon Hirschfield, M.D., Lily and Terry Horner Chair in Autoimmune Liver Disease Research, Toronto Centre for Liver Disease.
Charles McWherter, Ph.D., Chief Scientific Officer and President of Research and Development at CymaBay, commented, “We look forward to sharing results from the RESPONSE study, which is the culmination of years of clinical development of seladelpar in patients with PBC examining and confirming it’s treatment effects on cholestatic markers and symptoms. This is an important step forward in the process of obtaining regulatory review and potentially marketing authorization. We are extremely grateful to our team, investigators, and especially patients in the participation and collaboration in this endeavor. It’s a privilege once again to be invited to share these results at The Liver Meeting® 2023.”
Additionally, a poster presentation2 will highlight the comparison of the serum metabolomes of patients with PBC to matched healthy volunteers and a second poster presentation3 will evaluate seladelpar’s activity in a pre-clinical model of human PBC.
Presentations at the Liver Meeting® 2023 include:
Late-Breaking Oral Presentation:
Monday, November 13th 2:30 PM EST
1“Efficacy and Safety of Seladelpar in Patients with Primary Biliary Cholangitis in the RESPONSE Trial: A Phase 3 International, Randomized, Placebo-Controlled Study” (Abstract #5002)
Gideon M. Hirschfield, Christopher L. Bowlus, Marlyn J. Mayo, Andreas E. Kremer, John M. Vierling, Kris V. Kowdley, Cynthia Levy, Shusheela Carroll, Ke Yang, Yun-Jung Choi, Daria B. Crittenden, Charles A. McWherter
Poster Presentations:
Monday, November 8:00 – 5:00 PM EST
2“Widespread Dysregulation of Metabolic Stress Pathways is a Characteristic of Primary Biliary Cholangitis (PBC): Comparison of the Serum Metabolomes of PBC Patients to Matched Healthy Volunteers”(Abstract #4591-C)
Yun-Jung Choi, Jeff D. Johnson, Andrew Schwab, Charles A. McWherter
3“Seladelpar Activity in a Pre-Clinical Model of Human PBC” (Abstract #4573-C)
Mei Li, Yana Geng, Ke Luo, Dorenda Oosterhuis, Alan R. Gorter, Vincent De Meijer, Edward E. Cable and Peter Olinga
Congress attendees can visit CymaBay throughout the meeting at booth D3034.
A full list of presentations can be found on The Liver Meeting® 2023 website.
The presentations will also be made available on the CymaBay website.
About PBC
PBC is a rare, chronic inflammatory liver disease primarily affecting women (1 in 1,000 women over the age of 40 or about 130,000 total people in the US). PBC is characterized by impaired bile flow (known as cholestasis) and the accumulation of toxic bile acids in the liver, leading to inflammation and destruction of the bile ducts within the liver and causing increased levels of ALP and total bilirubin. The most common early symptoms of PBC are pruritus (itching) and fatigue, which can be debilitating for some patients. Progression of PBC is associated with an increased risk of liver-related mortality.
About Seladelpar
Seladelpar, an investigational treatment for people with PBC, is a first-in-class oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, or delpar, shown to regulate critical metabolic and liver disease pathways in indications with high unmet medical need. Preclinical and clinical data support its ability to regulate genes involved in bile acid synthesis, inflammation, fibrosis and lipid metabolism, storage, and transport.
About CymaBay
CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on improving the lives of people with liver and other chronic diseases that have high unmet medical need through a pipeline of innovative therapies. Our deep understanding of the underlying mechanisms of liver inflammation and fibrosis, and the unique targets that play a role in their progression, have helped us receive breakthrough therapy designation (U.S. Food and Drug Administration), Priority Medicines status (European Medicines Agency) and orphan drug status (U.S. and Europe) for seladelpar, a first-in-class investigational treatment for people with PBC. Our evidence-based decision-making and commitment to the highest quality standards reflect our relentless dedication to the people, families, and communities we serve. To learn more, visit www.cymabay.com and follow us on X (formerly Twitter) and LinkedIn.
Cautionary Statements
Any statements made in this press release regarding the potential for seladelpar to treat PBC and potentially improve clinical symptoms or outcomes of the disease, the potential benefits to patients and the future filing and commercialization plans of CymaBay 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; and effects observed in trials to date that may not be repeated in the future. 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, its Quarterly Reports 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.
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