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Wired News – CymaBay Therapeutics Starts Phase-2b Clinical Trials of Seladelpar for Treatment of Patients with Non-Alcoholic Steatohepatitis

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LONDON, UK / ACCESSWIRE / May 10, 2018 / If you want access to our free research report on CymaBay Therapeutics, Inc. (NASDAQ: CBAY), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=CBAY as the Company's latest news hit the wire. On May 08, 2018, the Company announced the initiation of Phase-2b proof of concept clinical trials of seladelpar for the treatment of patients with non-alcoholic steatohepatitis (NASH). The Company started the Phase-2b study with the screening of patients for the clinical trials. Register today and get access to over 1,000 Free Research Reports by joining our site below:


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NASH is a type of non-alcoholic fatty liver disease (NAFLD), in which liver fat builds up in the liver that leads to chronic liver inflammation and ultimately to fibrosis and cirrhosis. NASH is linked to the metabolic syndrome which is associated with obesity and diabetes and is a major health concern globally. Currently, there are no approved treatments available for NASH. CymaBay's drug candidateseladelpar is a potent, selective, orally active PPARδ agonist currently in development for the treatment of patients with the autoimmune liver disease, primary biliary cholangitis (PBC) and NASH. The data from earlier studies on mice models treated with seladelpar suggests that it has potent anti-inflammatory properties and demonstrated beneficial effects in animal models on lipids and glucose metabolism, liver fat content, and the development of liver fibrosis. This has lead the Company to believe that seladelpar could potentially benefit patients affected with NAFLD who are further at risk of developing NASH.

The Phase-2b Clinical Trial

The Phase-2b clinical trial is a randomized, placebo-controlled, parallel, dose-ranging study. The Company plans to enroll around 175 patients with liver biopsy-proven NASH at specialized investigational centers in the US. These candidates would be administered with seladelpar in doses of 10, 20, and 50 mg/day, and will be studied versus placebo in a 2:2:2:1 randomization. The primary endpoint is to study the change in liver fat content at 12 weeks from baseline by doing magnetic resonance imaging using the proton density fat fraction method (MRI-PDFF).

The secondary aim is to measure the effectiveness of seladelpar and study the histological improvement in NASH and fibrosis by comparing liver biopsy samples taken at baseline and 52 weeks. The Company also plans to assess the progress by taking MRI-PDFF measurements at 26 and 52 weeks of treatment and use the latest technologies for biochemical markers and non-invasive imaging to evaluate inflammation, fibrosis, and liver health. Stephen Harrison, M.D. from Medical Director of Pinnacle Clinical Research, will be the Principal Coordinating Investigator of the seladelpar Phase-2b NASH study.

Commenting on the start of the Phase-2b clinical trials for seladelpar, Pol Boudes, M.D.., Chief Medical Officer of CymaBay, said:

"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."

About Non-Alcoholic Steatohepatitis (NASH)

NASH is a liver disease where the development of a fatty liver in patients at risk, triggers inflammation and hepatocellular injury with or without liver fibrosis. It is estimated that the occurrence of NAFLD is affecting 20% to 40% of adults in countries adopting a western diet, and, out of these, nearly 10% to 20% of the patients progress to NASH. Patients with NASH are at a heightened risk of cirrhosis and hepatocellular carcinoma, and it is projected that in the coming years NASH would be the leading cause for liver transplant. The matter is further complicated as most of the NASH patients also suffer from obesity, insulin resistance with or without type 2 diabetes, hypertension, and dyslipidemia manifested by high serum cholesterol and triglycerides levels.

About CymaBay Therapeutics, Inc.

Newark, California-based CymaBay is a clinical-stage biopharmaceutical organization focused on developing therapies for liver and other chronic diseases with high unmet medical need. In addition to evaluating seladelpar in PBC and NASH, the Company's Phase-3 ready programs for arhalofenate, which is a potential urate-lowering anti-flare therapy for gout, has been licensed to Kowa Pharmaceuticals America, Inc. for development and commercialization in the US. The Company has two additional product programs in the pipeline which are in early stages of development and are lead candidates for liver and other chronic diseases.

Stock Performance Snapshot

May 09, 2018 - At Wednesday's closing bell, CymaBay Therapeutics' stock declined 5.20%, ending the trading session at $11.66.

Volume traded for the day: 969.65 thousand shares.

Stock performance in the previous six-month period – up 35.42%; past twelve-month period – up 237.97%; and year-to-date - up 26.74%

After yesterday's close, CymaBay Therapeutics' market cap was at $678.03 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.7% at the end of the session.


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