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
CT: New Haven
FL: Boca Raton, Lakewood Ranch, Miami, Tampa
KS: Kansas City
MN: Maplewood, Minneapolis
MS: Jackson, Tupelo
MO: Kansas City
NY: NYC, Rochester
NC: Asheville, Duke
PA: Bethlehem, Hershey, Pittsburgh
TN: Germantown, Knoxville, Nashville
TX: Dallas, Ft Worth, Houston, San Antonio
VA: Newport News, Richmond