News Releases

Two abstracts focus on the unique mechanism of action of seladelpar; a third focuses on characterizing patient risk of PBC disease progression

NEWARK, Calif., June 7, 2023 /PRNewswire/ -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with significant unmet need, today announced it will make three presentations at the European Association for the Study of the Liver (EASL)'s The International Liver Congress™ 2023. Featured results include novel aspects of the anti-pruritic and anti-fibrotic mechanisms of seladelpar, a first-in-class oral, selective PPARδ agonist, or "delpar," being developed for primary biliary cholangitis (PBC). This year's annual meeting will take place in Vienna, Austria, from June 21-24. 

The selected presentations include:

• Treatment with seladelpar was found to be correlated with decreases in pruritus and Interleukin-31 (IL-31) levels¹ in patients with PBC. We believe this to be the first intervention in PBC to show this correlation. IL-31 is a cytokine known to play a significant role in pruritus in a variety of other diseases.
• Transcriptomics data² produced from two distinct fibrosis models, coupled with a platform capable of searching publicly available databases, revealed new aspects of the action of seladelpar to reduce established fibrosis.
• An analysis³ revealing that patients previously treated with UDCA, and having elevated levels of alkaline phosphatase (ALP) that do not currently qualify for second-line treatment, very often had additional factors for risk of disease progression. This highlights the potential for a broader population of patients that may benefit from second-line therapy.

"It's a privilege to once again be presenting our data at EASL alongside the world's leading researchers in liver disease. Our ability to collaborate with this broad community of experts is vital to our goal to eventually bring seladelpar to people living with PBC," said Charles McWherter, Ph.D., Chief Scientific Officer and President of Research and Development at CymaBay. "We've long been searching for explanations as to why seladelpar had improved patient-reported pruritus in our clinical trials. These results begin to point the way to advance our understanding, not only for seladelpar, but if confirmed, for patients who have been frustrated by the experience of the debilitating sensation of itch for which there has been no clinical correlation. We look forward to sharing additional details at the event."

Seladelpar is currently being evaluated in RESPONSE, a global phase 3 registration study in patients with PBC. The top-line results are expected in the third quarter of 2023. CymaBay's development program for seladelpar also encompasses ASSURE, an open-label, phase 3 study designed to gather long-term safety and efficacy data from patients who have previously participated in seladelpar clinical trials.

Poster Presentation Details:

June 21^st 9am – 6pm CET
Abstract #TOP-063
¹Seladelpar treatment resulted in correlated decreases in serum IL-31 and pruritus in patients with primary biliary cholangitis (PBC): post-hoc results from the phase 3 randomized, placebo-controlled ENHANCE study
Andreas E. Kremer, Marlyn J. Mayo, Gideon Hirschfield, Cynthia Levy, Christopher L. Bowlus, David E. Jones, Charles A. McWherter, and Yun-Jung Choi
Presenter: Andreas E Kremer

June 21^st 9am – 6pm CET
Abstract #304
²Novel Pathways implicated in the seladelpar-mediated reductions of established liver fibrosis are identified from RNA-SEQ data using plex search and two independent mouse pharmacology datasets
Edward E. Cable, Douglas W. Selinger, Yun-Jung Choi, Charles A McWherter
Presenter: Edward Cable

June 21^st 9am – 6pm CET
Abstract #3489
³Baseline characteristics and risk profiles of 1111 patients with primary biliary cholangitis (PBC) in need of second-line therapy
Gideon M. Hirschfield, Kris Kowdley, Andreas E. Kremer, John M. Vierling, Christopher L. Bowlus, Cynthia Levy, Marlyn J. Mayo, Daria B. Crittenden, Mary E. Standen, Ke Yang, Yun-Jung Choi, Charles A. McWherter
Presenter: Gideon Hirschfield

For more information about EASL 2023, including the complete list of presentations, please visit: https://www.easlcongress.eu/

Congress attendees can visit CymaBay throughout the meeting at booth A6.

The presentations will also be made available after the congress on the CymaBay website, www.cymabay.com

About Primary Biliary Cholangitis
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 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 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 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 approval, launch and commercialization of seladelpar or timing or plans in regard thereto, including the timing of the release of top-line results in RESPONSE, as well as statements regarding the completion of ongoing clinical trials and subsequent regulatory submissions 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.

Public Relations Contact:                                   
Theresa Dolge
Evoke Kyne
(609) 915-2156
Theresa.Dolge@evokegroup.com

Investor Relations Contact:
Hans Vitzthum
LifeSci Advisors, LLC
(617) 430-7578
Hans@LifeSciAdvisors.com

SOURCE CymaBay Therapeutics