CymaBay scraps key NASH, PSC programs after lead drug triggers safety alarms — share price implodes
When CymaBay Therapeutics recently acknowledged defeat in a 12-week readout of its Phase II trial of seladelpar, the biotech grasped at “significant improvements in biochemical markers of liver injury” as a reason to remain hopeful about the 52-week biopsy results. But that hope is now dashed.
Not only did the drug fail to reduce liver fat, it also appeared to cause cell injury.
These “atypical histological findings” — including cases of suspected interface hepatitis — observed in patients who responded to their drug forced CymaBay to slam the brakes to its seladelpar clinical program, terminating the Phase IIb study in NASH in question and a Phase IIa in primary sclerosing cholangitis (PSC) as well as putting all studies in primary biliary cholangitis on hold.
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