CymaBay reports positive seladelpar data in PBC

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CymaBay Therapeutics (NASDAQ:CBAY) presented new data from a second interim analysis of its ongoing Phase 2 study of seladelpar in patients with primary biliary cholangitis (PBC), a type of liver disease that damages bile ducts, at The International Liver Congress in Paris.

The data demonstrate that in patients with PBC, seladelpar exhibits potent and sustained anti-cholestatic and anti-inflammatory efficacy over 26 weeks of administration. 

In addition, seladelpar was not associated with drug-induced pruritus, an unpleasant sensation that leads to scratching. Seladelpar also was generally safe and well tolerated, with no transaminase elevation safety signal. There were six serious adverse events and none were deemed related to seladelpar.

In a statement, Dr. Pol Boudes, CMO of CymaBay, said this is the third consecutive year in which seladelpar will be featured in the late-breaker category at one of the key international liver meetings.

“We have now firmly established doses of seladelpar with compelling efficacy and tolerability, which we expect to further confirm in a Phase 3 study planned to start in the second half of the year,” he added.

CymaBay also presented new data highlighting the mechanism of action of seladelpar and its pharmacokinetic and pharmacodynamic profile in two additional posters at The International Liver Congress.

Melane LaBelle Sampson