CymaBay Therapeutics Inc (NASDAQ:CBAY) tumbled in pre-market trade Tuesday after the company’s lead drug, seladelpar, posted disappointing results in a mid-stage clinical trial linked to nonalcoholic steatohepatitis (NASH).
NASH is liver inflammation and damage caused by a buildup of fat in the liver. Patients with this disease are often told they have a "fatty liver."
In the Phase 2 study, three oral doses of seladelpar, all performed worse than a harmless placebo, based on a non-invasive imaging test that measures decreases in liver fat.
Investors sent shares in the Newark, California-based company down nearly 40.4% to $6.60 in pre-market trade.
The study had enrolled 181 patients with moderate stage of NASH and treated them for 12 weeks.
Reductions in liver fat were minimal and “not significant” compared to a placebo, said the company in a statement.
“While the reductions in liver fat were minimal, we remain encouraged by the significant improvements in biochemical markers of liver injury that we observed at week 12,” said Dr Pol Boudes, chief medical officer at CymaBay Therapeutics.
Boudes said the 52-week liver biopsy data will allow the company to understand whether the improvement in liver injury markers will translate into histological, or microscopic improvement.
“The observed improvement in markers of liver injury are consistent with the observed effects of seladelpar in PBC and further support the potential for seladelpar to improve liver health,” said Boudes.
Contact Uttara Choudhury at [email protected]