CymaBay Therapeutics Presents Additional Analyses from Clinical Studies of Seladelpar for Patients with Primary Biliary Cholangitis at The Liver Meeting® 2022

NEWARK, Calif., Nov. 04, 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 encouraging seladelpar data in patients with primary biliary cholangitis (PBC) that are being presented at The Liver Meeting® of the American Association for the Study of Liver Diseases (AASLD), in Washington, DC (November 4^th – 8^th).

In 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 Christopher L. Bowlus MD, the chief of the Division of Gastroenterology and Hepatology at the University of California Davis, will be reporting the results of a pooled analysis from an open-label phase 2 study and a placebo (Pbo) controlled phase 3 study (ENHANCE) assessing the efficacy, safety, and tolerability of seladelpar at a daily dose of 5 mg or 10 mg in PBC patients who had an inadequate response or an intolerance to ursodiol. At 6 months, treatment with seladelpar resulted in significant improvements in total cholesterol (TC), LDL-C, HDL-C, and triglycerides (TG). Interestingly, a comparison of lipid lowering in patients with and without concomitant lipid therapy revealed that seladelpar achieved similar treatment effects.

“These results suggest that seladelpar treatment in patients with PBC and dyslipidemia may improve lipid profiles, which is important given that dyslipidemia is a common feature in patients with PBC,” said Dr. Christopher L. Bowlus.

A second poster presenting clinical data titled “Seladelpar, a PPAR-delta Agonist, Improves Inflammatory Lipid Mediators in the Serum Metabolome in Patients with Primary Biliary Cholangitis (PBC)”² will reveal that seladelpar treatment in patients with PBC resulted in broad changes in serum metabolomics. Seladelpar increased mitochondrial and peroxisomal fatty acid oxidation and significantly reduced levels of inflammatory lipid mediators. Untargeted global serum metabolomics provided mechanistic insight into metabolic pathways altered by seladelpar treatment of patients with PBC. These results suggest novel aspects by which the action of seladelpar may improve cholestasis and liver function 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 will examine 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 are honored to present once again this year at The Liver Meeting. Given that RESPONSE is now fully enrolled, we look forward to the opportunity in 2023 to share the results from this pivotal phase 3 study,” stated Charles McWherter, Ph.D., Chief Scientific Officer and President of Research and Development at CymaBay.

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, the potential benefits to patients and the anticipated timing of the release of clinical data 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:

Glenn Silver
Lazar-FINN Partners
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Glenn.silver@finnpartners.com

Investor Relations Contact:

Hans Vitzthum
LifeSci Advisors, LLC
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Hans@LifeSciAdvisors.com