CymaBay Therapeutics (NASDAQ: CBAY) stock fell to a two-year low of $4.82 on Tuesday after disappointing nonalcoholic steatohepatitis (NASH) trial data. The ongoing phase 2 trial showed patients with NASH who were treated with investigational drug seladelpar failed to significantly reduce liver fat when compared to placebo.
The company said treatment with seladelpar did result in a reduction in biomarkers associated with liver injury. Also, CymaBay remained encouraged by the significant improvements in biochemical markers of liver injury despite minimal reductions in liver fat.
In NASH, fat builds up in the liver, triggering inflammation and cell injury that can lead to serious complications like cirrhosis, or liver scarring. The prevalence of the nonalcoholic fatty liver disease is rising with estimates ranging from 20% to 40% of adults in countries adopting a western diet.
During last month, CymaBay reported a wider loss in the first quarter of 2019 due to higher operating expenses. The quarter was highlighted by significant clinical and regulatory accomplishments that continue to accelerate and support the development of seladelpar in primary biliary cholangitis (PBC) and NASH.
Research and development expenses increased by 96% year-over-year, due to increases in seladelpar-related clinical trial expenses. This includes start-up and enrollment activities related to Enhance PBC phase 3 clinical study, ongoing treatment of patients in NASH phase 2b clinical study, continued treatment of patients in PBC phase 2 clinical study, and execution of other NDA-enabling studies.
So far this year in the NASH space, there were several trial updates from companies like Gilead Sciences (NASDAQ: GILD) and Intercept Pharmaceuticals (NASDAQ: ICPT) but those remained unsatisfactory. Added to this, the latest disappointing data from CymaBay Therapeutics has turned out to be concerned for those who were looking for results in the NASH space.
Shares of CymaBay Therapeutics opened lower on Tuesday and is trading in the red territory on the Nasdaq. The stock has fallen over 52% in the past year and over 50% in the past three months.
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