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CymaBay Therapeutics Announces the Initiation of a Phase 2b Study of Seladelpar in Patients with Non-Alcoholic Steatohepatitis

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NEWARK, Calif., May 08, 2018 (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 it began screening of patients for a phase 2b proof of concept study of seladelpar for the treatment of non-alcoholic steatohepatitis (NASH).

NASH, a disease linked to the metabolic syndrome which is associated with obesity and diabetes, is a growing global concern for which no treatment is currently approved. The disease is manifested by the accumulation of fat in the liver that leads to chronic liver inflammation and ultimately to fibrosis and cirrhosis. Seladelpar is an orally administered, potent and selective peroxisome proliferator-activated receptor delta (PPARδ) agonist that is also in development for primary biliary cholangitis (PBC), an auto-immune inflammatory liver disease. Seladelpar has demonstrated potent anti-inflammatory activities in the clinic and has also demonstrated beneficial effects in animal models on lipids and glucose metabolism, liver fat content, and the development of liver fibrosis, further suggesting the potential for benefit in patients suffering from NASH.1, 2  

The phase 2b study is a randomized, placebo-controlled, parallel, dose-ranging study that is intended to enroll approximately 175 patients with liver biopsy proven NASH at specialized U.S. investigational centers. Seladelpar at doses of 10, 20, and 50 mg/day will be studied versus placebo in a 2:2:2:1 randomization. The primary efficacy outcome will be the change from baseline in liver fat content at 12 weeks as measured by magnetic resonance imaging using the proton density fat fraction method (MRI-PDFF). Among the secondary measures of efficacy, most notable is the evaluation of histological improvement in NASH and fibrosis as assessed by comparing liver biopsy samples taken at baseline and 52 weeks.   Additional important planned assessments include MRI-PDFF measurements at 26 and 52 weeks of treatment, as well as the use of the latest available additional technologies for biochemical markers and non-invasive imaging which reflect inflammation, fibrosis and liver health.

"I am excited about the start of this study and look forward to evaluating the potential for seladelpar to treat patients with NASH. I have been involved in the seladelpar clinical program for PBC, and the results so far have been encouraging. Some of the effects observed in other studies with seladelpar, such as its anti-inflammatory activity and the improvements in the metabolic parameters of decreased serum cholesterol and triglycerides, should be beneficial for NASH patients," said Stephen Harrison, MD, Medical Director of Pinnacle Clinical Research, and the principal coordinating investigator of the seladelpar phase 2b NASH study.

Pol Boudes, MD, Chief Medical Officer of CymaBay, added “There has been significant progress in the past couple of years to better characterize the progression of NASH, which has been driven by innovation in methods to measure the effect of treatments with new agents. We are in an ideal position to leverage advances in technology in evaluating the potential impact of seladelpar in NASH patients. We are also very excited to be collaborating with Dr. Harrison and his network of colleagues, as he has emerged as a recognized leader in conducting clinical studies in NASH.”

1 Bays HE, et al. MBX-8025, A Novel Peroxisome Proliferator Receptor-δ Agonist: Lipid and Other Metabolic Effects in Dyslipidemic Overweight Patients Treated with and without Atorvastatin. Clin Endocrinol Metab 2011; 96: 2889–97.

2 Haczeyni F., et al. The Selective Peroxisome Proliferator-Activated Receptor-Delta Agonist Seladelpar Reverses Nonalcoholic Steatohepatitis Pathology by Abrogating Lipotoxicity in Diabetic Obese Mice. Hepatology Communications 2017; 2017; 1:663–74.

About NASH

Non-alcoholic steatohepatitis 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 non-alcoholic 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 non-alcoholic steatohepatitis. Patients with non-alcoholic steatohepatitis are at increased risk of cirrhosis and hepatocellular carcinoma, and non-alcoholic steatohepatitis is projected in the coming years to be the leading reason for liver transplant. Further, most patients with non-alcoholic steatohepatitis 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. (CBAY) is a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet medical need. Seladelpar is a potent, selective, orally active PPARδ agonist, currently in development for the treatment of patients with primary biliary cholangitis (PBC), an autoimmune liver disease, and with non-alcoholic steatohepatitis (NASH).

Cautionary Statements

The statements in this press release regarding the potential for seladelpar to treat PBC and NASH, the potential benefits to patients, CymaBay’s expectations and plans regarding 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.

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Hans Vitzthum
LifeSci Advisors, LLC

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Source: CymaBay Therapeutics, Inc.