CymaBay Therapeutics Inc (NASDAQ: CBAY) has announced the presentation of promising seladelpar findings in primary biliary cholangitis (PBC) patients at The International Liver Congress 2022 of the European Association for the Study of Liver (EASL) held between June 22 and June 26, 2022, in London, UK.
CymaBay presents findings of seladelpar in PBC
University of Toronto’s Associate Professor for Toronto Centre for Liver Disease Bettina Hanssen presented a poster titled, “Seladelpar Treatment of Patients With Primary Biliary Cholangitis (PBC) For 2 Years Improves the GLOBE PBC Score and Predicts Improved Transplant-Free Survival.” Bettina reported on GLOBE score improvement after seladelpar treatment for two years and indicated transplant-free survival. The GLOBE score is a recognized risk assessment measure for PBC patients that estimates transplant-free survival.
PBC patients who had failed the open-label, one-year second phase study of everyday oral seladelpar treatment due to an inadequate reaction or intolerance to UDCA. Patients could enroll in an open-label extended study after one year. A mean (SD) difference from baseline in the GLOBE score of 50 patients treated with oral seladelpar 5 mg and 10 mg daily for two years was observed.
Bettina commented, “These findings demonstrate that seladelpar treatment over 2 years resulted in a sustained decrease in GLOBE score for patients with PBC. These results provide an estimate of seladelpar’s treatment effect on transplant-free survival for patients with PBC supporting its continued long-term evaluation in patients with PBC.”
The second presentation described Seladelpar’s anticholestatic mechanism
The second presentation was by Dr Bernd Schnabl of the University of California, describing bile acid synthesis suppression by seladelpar and showing FGF-21 signaling’s role. The results offer new insight into seladelpar’s anti-cholestatic mechanism.
CymaBay Therapeutics Chief Medical Officer Dennis Kim said We continue to be encouraged by the potential key role seladelpar can play in providing benefit to patients with PBC. We look forward to our continued collaboration with our academic partners and investigators to further explore how this first and only seladelpar in development for treating PBC can advance the care and quality of life for patients with PBC over time.”