In November 2019, CymaBay Therapeutics Inc. (NASDAQ:CBAY) received the most disappointing news, which had the potential of disrupting its operations. The FDA had frozen the clinical trials of seladelpar. The drug was expected to be a potential candidate for treating three liver diseases. It was developed for primary biliary cholangitis (PBC), nonalcoholic steatohepatitis (NASH), and primary sclerosing cholangitis (PSC).
The FDA’s pause of the drug’s development was because it showed signs of liver damage in some patients who had been enrolled in CymaBay’s mid-stage studies in NASH. The disease’s symptoms include fatty buildup, which more often than not results in inflammation and eventually scarring the organ.
The FDA’s Decision to Lift the Clinical Hold
Before the studies of seladelpar were halted, some improvements on stabilization of the patients’ biochemical measures of inflammation ws observed. There were no liver-related adverse events, according to the CEO of CymaBay, Sujal Shah. However, the biopsies may have shown liver damage, which led to the halting of the trials.
Nonetheless, the company says they have resumed the trials on Seladelpar following a decision by the FDA to lift the clinical hold. This is a pivotal event for both the company and the drug, which seemed a very promising treatment for anti-cholestatic and anti-inflammatory drugs in patients with PBC.
The Clearance to Recommence Tests of Seladelpar Comes At a Stormy Time in Drug Development
The news to resume the trials would not have come at a better time. Ss Shah explained, ” We are gratified and energized to be able to once again advance seladelpar into a registrational program to confirm its benefit. It is our unwavering goal to one day make it available…’’
However, it may be too early for the company to celebrate the restart of the tests of seladelpar. This is because of the many questions being raised regarding the consistency of liver biopsy as an endpoint for NASH trials. On the other hand, doctors have continuously carried out blood-based tests to diagnose NASH.
Over the years, liver biopsy has always been a challenge in liver diseases resulting in more problems when trying to assess new therapies.