CymaBay’s Phase III seladelpar divides experts of trial reboot worthiness in PBC due to gargantuan burden to prove safety

06 Dec 2019

The possible addition of liver biopsies in CymaBay Therapeutics’ (NASDAQ:CBAY) paused Phase III seladelpar trial in primary biliary cholangitis (PBC) means an unlikely restart, some experts said. Others however noted newly reported interface hepatitis events could potentially be independent of seladelpar use and there is an overall lack of information on their origins.

On 25 November, CymaBay announced halting its Phase III ENHANCE trial (NCT03602560) in second-line PBC. Also, its Phase IIb nonalcoholic steatohepatitis (NASH) and Phase II primary sclerosing cholangitis (PSC) trials were terminated following interface hepatitis detected in the NASH trial. CymaBay stock dived more than 75% upon the announcement, with a current market cap of USD 114m.

Regardless, even with limited information, some experts speculated interface hepatitis could be due to an increase in alanine aminotransferase (ALT) or autoimmune reactions triggered by seladelpar.

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