Health and Healthcare
Is CymaBay Therapeutics' Liver Disease Trial Sunk?
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CymaBay Therapeutics Inc. (NASDAQ: CBAY) shares were nearly halved in Tuesday’s premarket trading after the company provided an update from its midstage study of seladelpar for the treatment of nonalcoholic steatohepatitis (NASH).
Specifically, these topline results come from the firm’s ongoing 52-week Phase 2b study of seladelpar. Currently, seladelpar is a potent and selective peroxisome proliferator-activated receptor delta agonist currently in development for NASH and primary biliary cholangitis.
The primary endpoint was the relative change in liver fat content from baseline to 12 weeks. So far, treatment with seladelpar resulted in robust and clinically meaningful reductions in markers associated with liver injury.
However, treatment with seladelpar resulted in minimal reductions in liver fat that were not significant when compared to placebo.
The majority of treatment-emergent adverse events were mild to moderate in severity and deemed unrelated to the study drug. There were two serious adverse events that occurred after randomization through week 12, neither of which was deemed to be related to the study drug.
Dr. Stephen Harrison, M.D., Medical Director of Pinnacle Clinical Research, founder of Summit Clinical Research and principal coordinating investigator of the seladelpar Phase 2b NASH Study, commented:
NASH is a complex, multifactorial disease that can lead to liver injury and fibrosis. These data demonstrated a notable decrease in biochemical markers of liver injury despite lack of overall improvement in liver fat. The dose response relationship in serum ALT reduction is very encouraging and supports the potential histopathologic benefit of seladelpar in patients with NASH. We are looking forward to the 52-week histology results.
After Tuesday’s opening bell, shares of CymaBay trade at $5.30, in a new 52-week range of $4.82 to $15.00. The stock has a consensus price target of $21.60.
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