CymaBay Therapeutics to Present at the 2021 NASH-TAG Conference

Rhea-AI Summary

CymaBay Therapeutics (NASDAQ: CBAY) announced the presentation of two studies on seladelpar at the NASH-TAG Conference from March 11-13, 2021. The first, a poster presentation, highlights the assessment of NASH pathologies using machine learning from a Phase 2 trial. The second, an oral presentation, discusses the FDA hold and release of seladelpar. These presentations aim to stimulate further research into NASH, a disease affecting 20-40% of adults with detrimental liver effects. Seladelpar has received multiple designations from regulatory agencies.

NEWARK, Calif., March 11, 2021 (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 two seladelpar presentations will be delivered during the NASH-TAG Conference being held March 11^th – 13^th.

“We are excited to have the opportunity to share quantitative data highlighting the common occurrence of interface hepatitis and portal inflammation in baseline biopsies from our Phase 2 study in NASH,” Sujal Shah, President and CEO of CymaBay, commented. “We hope that the data presented at NASH-TAG will catalyze more research into features of NASH pathology that are not often reported and that may result in a direct benefit to patients in the future.”

Poster Presentation
“Quantitative assessment of NASH pathologies in 152 baseline H&E slides from a Phase 2 trial using the Path AI machine learning algorithm” (Abstract #1)
Edward E. Cable, Charles A. McWherter, Yun J. Choi, Sujal Shah and Oscar M. Carrasco-Zevallos and the CymaBay (Newark, CA) and Path AI (Boston, MA) teams
March 11 – 13^th

Oral Presentation
“Seladelpar’s FDA Hold and Release: What Happened and What Did We Learn?”
Stephen Harrison, MD
March 12^th 5:00 – 5:15 PM MT

Abstract #1 was selected as one of six “distinguished” posters for the conference of the more than 30 accepted for presentation. Both of the presentations listed above will be made available on the CymaBay website.

About NASH

Nonalcoholic steatohepatitis (NASH) involves the development of a fatty liver that, in patients at risk, triggers inflammation and hepatocellular injury with or without liver fibrosis. The prevalence of nonalcoholic fatty liver disease is increasing, with estimates ranging from 20% to 40% of adults in countries adopting a western diet. Ten to 20% of patients with fatty liver disease progress to NASH. Patients with NASH are at increased risk of cirrhosis and hepatocellular carcinoma, and NASH is projected in the coming years to be the leading reason for liver transplant. Further, most patients with NASH have coexisting obesity, insulin resistance with or without type 2 diabetes, hypertension, and dyslipidemia manifested by high serum cholesterol and triglycerides levels.

About CymaBay

CymaBay Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need.  CymaBay is developing seladelpar, a potent, selective, orally active PPARδ agonist for patients with primary biliary cholangitis (PBC). Seladelpar has received an orphan designation from the US Food and Drug administration (FDA) and the European Medicine Agency (EMA). Seladelpar also received Breakthrough Therapy Designation from the FDA for early stage PBC and PRIority MEdicines status from the EMA. CymaBay is currently commencing a global, Phase 3 registration study of seladelpar for PBC. This study is a 52-week, placebo-controlled, randomized, phase 3 study to evaluate the safety and efficacy of seladelpar (RESPONSE) in patients with PBC. For more information about RESPONSE, please visit: www.pbcstudies.com. 

Cautionary Statements

The statements in this press release regarding the potential for seladelpar to treat PBC or NASH, the potential benefits to patients, CymaBay’s expectations and plans regarding its current and future clinical trials and CymaBay’s ability to fund current and planned clinical trials 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:                                    

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 are the key details of CymaBay's seladelpar presentations at the NASH-TAG Conference?

CymaBay is presenting two studies on seladelpar at the NASH-TAG Conference from March 11-13, 2021, focusing on NASH pathologies and the FDA hold and release.

When and where is the NASH-TAG Conference taking place for 2021?

The NASH-TAG Conference is being held from March 11-13, 2021.

What is the significance of the poster presentation on NASH at the NASH-TAG Conference?

The poster presentation discusses the quantitative assessment of NASH pathologies using machine learning from a Phase 2 trial, potentially revealing new insights into the disease.

What are the implications of seladelpar's FDA hold and release presentation?

The presentation will cover the circumstances surrounding seladelpar's FDA hold and release, providing insights for future clinical trials.

What is the prevalence of NASH among adults according to the press release?

The prevalence of nonalcoholic fatty liver disease ranges from 20% to 40% among adults, with 10% to 20% progressing to NASH.