CymaBay puts PBC Seladelpar Clinical Trials on hold

Seladelpar, a drug developed for PBC patients, has shown positive results in Phase 2 studies- normalizing ALP levels, while not associated with itching. In November with FDA breakthrough therapy designation for PBC, CymaBay announced an extended Phase 3 study. Previously, a 52 week study of Seladelpar was undertaken for NASH (Non-alcoholic steatohepatitis) patients.
Today CymaBay announced that it will be putting on hold its PBC clinical trials, while halting other trials. It is important to note that as notified publicly by CymaBay, there have not been any concerns raised in the PBC trial, but the company is acting out of an abundance of caution, and with patient safety foremost.
The company cited atypical findings observed in the study of NASH patients; while blood work (biochemical) improved, biopsies showed abnormalities in liver cells (histology). CymaBay has initiated a series of investigative actions to better understand these findings with the focus on ensuring patient safety and care and will be updating all stakeholders regularly.
We feel it’s important to make sure you are aware of this issue. If you are currently enrolled in a Seladelpar study and have any questions or concerns, you should talk to your doctor.
Seladelpar clinical trial sites
AZ: Chandler, Phoenix, Tucson
CA: Los Angeles, Stanford, UC Davis, San Francisco
CO: Denver
CT: New Haven
FL: Boca Raton, Lakewood Ranch, Miami, Tampa
GA: Atlanta
IL: Chicago
IN: Indianapolis
KS: Kansas City
LA: Tulane
MA: Boston
MI: Novi
MN: Maplewood, Minneapolis
MS: Jackson, Tupelo
MO: Kansas City
NY: NYC, Rochester
NC: Asheville, Duke
OH: Cleveland
PA: Bethlehem, Hershey, Pittsburgh
TN: Germantown, Knoxville, Nashville
TX: Dallas, Ft Worth, Houston, San Antonio
UT: Murray
VA: Newport News, Richmond
WA: Seattle
AB: Calgary
ON: Toronto
QC: Montreal
MB: Winnipeg