Seladelpar Phase 2 Study Selected for DDW Presidential Plenary Session
NEWARK, Calif., May 11, 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 multiple Phase 2 and Phase 3 study presentations on seladelpar, the first delpar currently in development for the treatment of PBC, will be delivered during Digestive Disease Week® (DDW) May 21 – 24.
An oral presentation selected for the AASLD Presidential Plenary session at DDW titled, “Seladelpar Treatment of Patients With Primary Biliary Cholangitis (PBC) For 2 Years Improves the GLOBE PBC Score and Predicts Improved Transplant-Free Survival,”1 will be delivered by Bettina Hansen, PhD, Associate Professor Toronto Centre for Liver Disease, University of Toronto. This presentation will highlight the improvement in GLOBE score following seladelpar treatment over two years and predicted transplant-free survival. The GLOBE score is a validated risk-assessment tool providing an estimate of transplant-free survival for patients with PBC.
A second clinical presentation titled “Efficacy, Safety, and Tolerability of Seladelpar in Patients With Compensated Liver Cirrhosis Due to Primary Biliary Cholangitis (PBC): A Pooled Analysis of Phase 2 and Phase 3 Studies,”2 will be delivered by Stuart Gordon, MD, Professor of Medicine at Wayne State University and Director of the Division of Hepatology and GI Research at Henry Ford Health System. This poster presentation will highlight the treatment effects of seladelpar in compensated cirrhotic patients over a three-month treatment period.
A third clinical presentation is titled “Treatment With Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and Prior Experience With Obeticholic Acid (OCA) or Fibrates”3 authored by Dr. Aliya Gulamhusein, MD, Assistant Professor and Clinical Investigator, Toronto Centre for Liver Disease, University of Toronto. This poster presentation will highlight the efficacy after three months of treatment with seladelpar in enrolled patients in Phase 2 and Phase 3 studies that had prior experience with OCA, fibrates, or both.
Dr. Dennis Kim, Chief Medical Officer of CymaBay Therapeutics, commented, “As the first and only delpar in development for treatment of PBC, seladelpar directly targets cell types that have a specific role in PBC, and these Phase 2 and 3 study results expand our body of evidence that supports its use in normalizing liver biochemistry and improving quality of life in PBC by reducing important symptoms such as fatigue and itching, including in higher-risk patients.”
DDW Presidential Plenary Presentation:
May 22nd 8:00 AM PDT
1“Seladelpar Treatment of Patients With Primary Biliary Cholangitis (PBC) For 2 Years Improves the GLOBE PBC Score and Predicts Improved Transplant-Free Survival”
Bettina E. Hansen, Elaine Watkins, Ke Yang, Yun-Jung Choi, Charles A. McWherter, Gideon M. Hirschfield,
for the Seladelpar Long-Term Study Investigators
Clinical Poster Presentations:
May 22nd 12:30 PM PDT
2“Efficacy, Safety, and Tolerability of Seladelpar in Patients With Compensated Liver Cirrhosis Due to Primary Biliary Cholangitis (PBC): A Pooled Analysis of Phase 2 and Phase 3 Studies”
Stuart C Gordon, Palak Trivedi, Christopher Bowlus, Michael R Galambos, Aparna Goel, Aliya Gulamhusein, Cynthia Levy, Guy Neff, Carmen Stanca, Douglas Thorburn, Bruce Bacon, Brian Borg, Yvonne Döerffel, Lisa Forman, Bradley Freilich, Liana Gheorghe, María Saraí González-Huezo, Stephen Harrison, Jonathan Huang, Sook-Hyang Jeong, Seung Up Kim, John Lake, Joseph Odin, Won Young Tak, Hillel Tobias, John M. Vierling, Ke Yang, Alexandra (Sasha) Steinberg, Yun-Jung Choi, Charles McWherter, Marlyn J. Mayo
May 22nd 12:30 PM PDT
3“Treatment With Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and Prior Experience With Obeticholic Acid (OCA) or Fibrates”
Aliya Gulamhusein, Guy Neff, Aparna Goel, Marlyn J. Mayo, Carmen Stanca, Christopher Bowlus, Lisa Forman, Pietro Invernizzi, Frederik Nevens, Ehud Zigmond, Eli Zuckerman, Ke Yang, Yun-Jung Choi, Alexandra (Sasha) Steinberg, Charles McWherter, Kris V. Kowdley
A full list of presentations can be found on https://ddw.org/.
The presentations will also be made available on the CymaBay website.
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.
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.
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.
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.
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