CymaBay Therapeutics Announces Presentations During The International Liver Congress™ 2022
CymaBay Therapeutics (NASDAQ: CBAY) announced multiple presentations of its drug seladelpar at The International Liver Congress 2022 from June 22-26 in London. Key presentations include:
- A study on seladelpar's effect on improving the GLOBE score for transplant-free survival in PBC patients over two years.
- A preclinical comparison of seladelpar with other fibrosis-reducing agents.
- An oral presentation on how seladelpar suppresses bile acid synthesis via FGF-21 signaling.
Dr. Dennis Kim emphasized the significance of these findings for PBC patients.
- Seladelpar shows potential for significantly improving transplant-free survival in PBC patients as indicated by GLOBE score improvements.
- The company collaborates with esteemed academic institutions for credible clinical data presentations.
- CymaBay received breakthrough therapy designation and orphan drug status, enhancing its market position.
- Risks associated with the further development of seladelpar, including uncertainties in clinical trial outcomes.
- Potential for unmet expectations based on forward-looking statements regarding efficacy.
NEWARK, Calif., June 08, 2022 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that multiple seladelpar presentations will be delivered during The International Liver Congress™ 2022 of the European Association for the Study of Liver (EASL) which will be held in London, UK from June 22nd – 26th.
- A poster presentation1 in collaboration with Dr. Bettina Hansen, PhD, Associate Professor of Biostatistics at the University of Toronto, Toronto, CA and Erasmus University Medical Center, Rotterdam, NL, will be made highlighting 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 preclinical poster presentation2 will compare the fibrosis-reducing activities of the Farnesoid X Receptor (FXR) agonist, obeticholic acid; the Peroxisome Proliferator-activated receptor delta (PPARd) agonist, seladelpar, and the Thyroid Hormone Receptor (THR) agonist, resmetirom in the carbon tetrachloride (CCl4) mouse model.
- An oral presentation3 in collaboration with Professor Bernd Schnabl at the University of California San Diego, will describe the suppression of bile acid synthesis by seladelpar and reveal the role of FGF-21 signaling, a previously known regulator of bile acid synthesis.
Dr. Dennis Kim, Chief Medical Officer of CymaBay Therapeutics, commented, “We are excited to have the opportunity to present once again this year at the International Liver Congress™. We are honored to collaborate with our academic partners and investigators and to share clinical data that highlights the potential key role seladelpar can play in improving the lives of PBC patients.”
Presentations at The International Liver Congress™ 2022 include:
Poster Presentations:
June 23rd 9:00 – 18:30 BST
1529:
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
June 24th 9:00 – 18:00 BST
1518:
2“Comparative fibrosis-reducing activities of farnesoid X receptor (FXR), peroxisome-proliferator activated receptor delta (PPAR) and thyroid hormone receptor (THR) agonists in the carbon tetrachloride mouse model”
Edward Cable, Jeffrey Stebbins, Yun-Jung Choi, Jiangao Song, Prasad Manchem, Sanjay Pandey, Charles A. McWherter
Oral Presentation:
June 25th 9:00 AM BST
2726:
3“The selective PPAR-delta agonist seladelpar suppresses bile acid synthesis by reducing hepatocyte CYP7A1 through the FGF21 pathway”
Tetsuya Kouno, Xiao Liu, Tatiana Kisseleva, Edward E. Cable, Bernd Schnabl
Congress attendees can visit CymaBay throughout the meeting at booth 93.
A full list of presentations can be found on The International Liver Congress ™ 2022 website.
The presentations will also be made available later this month 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:
Glenn Silver
Lazar-FINN Partners
(973) 818-8198
Glenn.silver@finnpartners.com
Investor Relations Contact:
Hans Vitzthum
LifeSci Advisors, LLC
(617) 430-7578
Hans@LifeSciAdvisors.com
FAQ
What was announced by CymaBay Therapeutics regarding seladelpar at The International Liver Congress 2022?
When is The International Liver Congress 2022 taking place?
What are the key findings related to seladelpar presented at the congress?
What is the GLOBE score in relation to seladelpar's treatment?
What is CymaBay's focus in drug development?
