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
Elafibranor, phase 2 trial has shown positive preliminary results in helping those PBC patients who do not respond to UDCA (Urso). In addition, Elafibranor has recently been granted “Breakthrough Therapy Designation” by the FDA as well as “Orphan Drug Designation”. Read more.
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.