NEWARK, Calif., Oct. 03, 2022 (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 three abstracts related to its seladelpar development program for the treatment of primary biliary cholangitis (PBC) will be presented at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD), in Washington, DC (November 4th – 8th).
A clinical poster presentation titled “Seladelpar Improved the Lipid Profile of Patients with Primary Biliary Cholangitis (PBC): Results from Phase 2 and 3 Clinical Studies”1 will be delivered by Christopher L. Bowlus MD, the chief of the Division of Gastroenterology and Hepatology at the University of California Davis. This presentation will highlight that treatment with seladelpar resulted in significant reductions in total cholesterol, LDL-C and triglycerides in PBC patients, without meaningful changes in HDL-C.
“Dyslipidemia is a common feature in patients with PBC. Therefore, this presentation provides valuable information of treatment effects of seladelpar which showed improvement in the lipid profile over the course of six months of treatment,” said Dr. Christopher L. Bowlus. “Our patients with PBC are living longer with earlier diagnosis and treatment, which makes controlling lipid profiles, especially LDL-C, even more important in potentially improving their cardiovascular risks.”
In addition, a poster presentation titled “Seladelpar, a PPAR-delta Agonist, Improves Inflammatory Lipid Mediators in the Serum Metabolome in Patients with Primary Biliary Cholangitis (PBC)”2 will shed light on the potential mechanisms by which seladelpar reduces inflammation in patients with PBC.
Finally, a preclinical poster presentation titled “Effects of Single and Multiple Doses in Mice of the Selective PPAR-delta Agonist Seladelpar on Diurnal Markers of Bile Acid Synthesis”3 examines the effects of light cycle and food intake as important time-of-day variables that impact bile acid synthesis. A mouse model was used to establish the pharmacological inhibition of bile acid synthesis on the background of the natural variation of bile acid levels during the day.
“We continue to elucidate the delpar mechanisms for their ability to favorably impact lipid metabolism, bile acid homeostasis and inflammation, central aspects of the pathobiology of PBC,” stated Charles McWherter, Ph.D., Chief Scientific Officer at CymaBay. “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® 2022 include:
1“Seladelpar Improved the Lipid Profile of Patients with Primary Biliary Cholangitis (PBC): Results from Phase 2 and 3 Clinical Studies” (Abstract #: 37934)
Christopher L. Bowlus, Yun-Jung Choi, Ke Yang, Barry Crittenden, Dennis Kim, Charles A. McWherter
2“Seladelpar, a PPAR-delta Agonist, Improves Inflammatory Lipid Mediators in the Serum Metabolome in Patients with Primary Biliary Cholangitis (PBC)” (Abstract #: 35155)
Yun-Jung Choi, Jeff D. Johnson, Andrew Schwab, Charles A. McWherter
3“Effects of Single and Multiple Doses in Mice of the Selective PPAR-delta Agonist Seladelpar on Diurnal Markers of Bile Acid Synthesis” (Abstract #: 37809)
Edward E. Cable, Jeffrey W. Stebbins, Yun-Jung Choi, Jiangao Song, Charles A. McWherter
Congress attendees can visit CymaBay throughout the meeting at booth 651.
A full list of presentations can be found on The Liver Meeting Digital Experience™ 2022 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) over the age of 40. 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 alkaline phosphatase (ALP) and total bilirubin. The most common early symptoms of PBC are itching (pruritus) and fatigue, which can be very debilitating for some patients. Progression of PBC is associated with an increased risk of liver cancer and liver-related mortality.
About Seladelpar
Seladelpar is a first-in-class oral, selective PPARδ agonist 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 acids 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 treatment for people with primary biliary cholangitis (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 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 of the disease and the potential benefits to patients 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.
Public Relations Contact:
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Lazar-FINN Partners
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Glenn.silver@finnpartners.com
Investor Relations Contact:
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LifeSci Advisors, LLC
(617) 430-7578
Hans@LifeSciAdvisors.com
