NEWARK, Calif., Oct. 01, 2021 (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 presentations of results from clinical and preclinical studies of seladelpar will be delivered during The Liver Meeting Digital Experience™ 2021 (TLMdX) of the American Association for the Study of Liver Diseases (AASLD), which will be held online November 12
th
– 15
th
.
An oral presentation titled “Long-Term Safety and Efficacy of Seladelpar in Patients with Primary Biliary Cholangitis”
1
will be delivered by Dr. Marlyn J. Mayo, MD, Professor and Liver Disease Specialist, University of Texas Southwestern Medical Center. This presentation will highlight the efficacy and safety of seladelpar during 2 years of treatment in patients with primary biliary cholangitis (PBC). The mean percent change in alkaline phosphatase (ALP) from baseline was -42% and -50% after 1 and 2 years, respectively. Over 2 years, there were sustained reductions in ALT, AST, and GGT. Total bilirubin and platelet levels remained stable. Seladelpar appeared safe and well-tolerated. These data support that long-term treatment with seladelpar resulted in continued improvement in markers of cholestasis after 1 year.
“These 2 year results are important because they provide valuable insight into seladelpar’s potential ability to further reduce biomarkers of cholestasis and hepatocellular injury after 1 year of treatment,” said Dr. Marlyn Mayo, MD.
A second clinical presentation titled “Efficacy and Safety of Seladelpar in Patients with Compensated Cirrhosis and Evidence of Portal Hypertension due to Primary Biliary Cholangitis”
2
will be delivered by Dr. Cynthia Levy, MD, Professor of Medicine, University of Miami. This electronic poster presentation will highlight the treatment effects of seladelpar in compensated cirrhotic patients with portal hypertension after 3 months, which led to ALP changes of -30% in the 5 mg and -45% in the 10 mg groups. Total bilirubin, platelets, albumin, and INR either improved or remained stable. Seladelpar appeared safe and well-tolerated. Efficacy, safety, and tolerability in patients with compensated cirrhosis and portal hypertension was comparable to that of non-cirrhotic patients.
In addition, a preclinical poster presentation
3
will highlight seladelpar’s effects on reducing established fibrosis in both the liver and kidneys of a non-obese diabetic inflammation and fibrosis mouse model.
Dr. Dennis Kim, Chief Medical Officer of CymaBay Therapeutics, commented, “We look forward to the opportunity to present data highlighting the efficacy and safety of seladelpar over 2 years in patients with PBC. In addition, we are excited to share additional data that supports the potential for seladelpar to offer PBC patients with compensated cirrhosis and evidence of portal hypertension a safe and effective treatment option. We continue to gather additional data in cirrhotic and noncirrhotic patients with PBC in RESPONSE, our Phase 3 global study that is currently recruiting and enrolling patients.”
Oral Presentation:
November 14
th
1:00 PM EST
106:
1
“Long-Term Safety and Efficacy of Seladelpar in Patients with Primary Biliary Cholangitis”
Marlyn J. Mayo, John M. Vierling, Christopher L. Bowlus, Guy Neff, Michael R. Galambos, Stuart C. Gordon, Brian Borg, Cynthia Levy, Stephen A. Harrison, Paul J. Thuluvath, Aparna Goel, Mitchell L. Shiffman, Alexandra Steinberg, Emily Xu, Ke Yang, Yun-Jung Choi, Klara Dickinson, Charles McWherter
Clinical Poster Presentation:
November 12
th
– 15
th
1269:
2
“Efficacy and Safety of Seladelpar in Patients with Compensated Cirrhosis and Evidence of Portal Hypertension due to Primary Biliary Cholangitis”
Cynthia Levy, Joseph A. Odin, Guy Neff, Palak Trivedi, Liliana-Simona Gheorghe, Christopher L. Bowlus, John M. Vierling, Aliya F. Gulamhusein, Sook-Hyang Jeong, Emily Xu, Ke Yang, Yun-Jung Choi, Elaine Watkins, Charles McWherter
Preclinical Poster Presentation:
November 12
th
– 15
th
1334:
3
“Seladelpar reduces established Liver and Renal Fibrosis in the Non-obese Diabetic Inflammation and Fibrosis (NIF) Mouse Model”
Edward Cable, Sofia Mayans, Dan Holmberg
Congress attendees can visit CymaBay throughout the meeting at the CymaBay booth in the Exhibitors section of the TLMdX homepage.
A full list of presentations can be found on
The Liver Meeting Digital Experience™ 2021 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, 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, 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
[email protected]
Investor Relations Contact:
Hans Vitzthum
LifeSci Advisors, LLC
(617) 430-7578
[email protected]
