CymaBay – Seladelpar – re-initiating Phase 3 clinical trial for PBC

On November 25, 2019, CymaBay halted all clinical trials of seladelpar after atypical histologic findings with no clinical or laboratory correlates were identified at the planned end-of treatment biopsy review of a 52-week Phase 2 NASH study. The FDA concurred with this decision and placed all active INDs for seladelpar on clinical hold. CymaBay committed to an in-depth investigation of these findings and comprehensive safety evaluation that concluded with an independent, expert panel review involving some of the world’s leading liver pathologists and hepatologists. The expert panel found no clinical, biochemical or histological evidence of seladelpar-related liver injury in the Phase 2 NASH study and unanimously supported re-initiating clinical development of seladelpar pending approval by the FDA. Based on the results of the investigation and the expert panel conclusions, FDA concluded that clinical trials for NASH, PBC and PSC may resume.

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 

Testing Mirtazapine on Mice

University of Calgary PBC researchers tested the anti-depressant mirtazapine on mice and found promising results. Their report concluded that mirtazapine may represent a novel therapeutic approach to autoimmune liver disease.  We look forward to see the next steps in this research.  Read the research findings here.