CymaBay Therapeutics Presents Positive PBC Data at the International Liver Congress™ 2022
NEWARK, Calif., June 22, 2022 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced encouraging seladelpar data in patients with primary biliary cholangitis (PBC) that are being presented at The International Liver Congress™ 2022 of the European Association for the Study of Liver (EASL) which will be held in London, UK from June 22nd – 26th.
In a poster presentation titled, “Seladelpar Treatment of Patients With Primary Biliary Cholangitis (PBC) For 2 Years Improves the GLOBE PBC Score and Predicts Improved Transplant-Free Survival,”1 Bettina Hansen, PhD, Associate Professor Toronto Centre for Liver Disease, University of Toronto, will be reporting the improvement in GLOBE score following seladelpar treatment over two years and predicted transplant-free survival. The GLOBE score is a validated risk-assessment tool providing an estimate of transplant-free survival for patients with PBC.
Patients with PBC having an incomplete response or intolerance to UDCA (defined as alkaline phosphatase (ALP) = 1.67xULN) had completed an open-label one-year phase 2 study of daily oral seladelpar therapy (NCT: 02955602). After 1 year, patients were eligible for an open label long-term study (NCT: 03301506). Treatment of 50 patients with oral seladelpar 5 mg or 10 mg daily for 2 years resulted in a mean (SD) change from baseline in GLOBE score of -0.417 (0.269), resulting in a corresponding hazard ratio of 0.66 for transplantation or death compared to no prior treatment with seladelpar (baseline). The improvement in GLOBE score and predicted survival did not depend on age. However, an analysis of subpopulations of high risk patients by GLOBE score (> 0.3) revealed that while patients of all ages improved, the younger patients tended to have numerically greater improvements, although these differences did not achieve significance.
“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,” said Dr. Bettina Hansen.
An oral presentation2 by Dr. Bernd Schnabl, Professor of Medicine at the University of California San Diego, will describe the suppression of bile acid synthesis by seladelpar and reveal the role of FGF-21 signaling, a previously known regulator of bile acid synthesis. These results provide new insights into the anti-cholestatic mechanism of seladelpar.
Dr. Dennis Kim, Chief Medical Officer of CymaBay Therapeutics, commented, “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 collaboratation with our academic partners and investigators to further explore how this first and only delpar in development for the treatment of PBC can advance the care and quality of life for patients with PBC over time. We want to extend our sincere gratitude to the patients and investigators who have participated in our clinical studies and look forward to completing our RESPONSE global Phase 3study for seladelpar in PBC.
Presentations at The International Liver Congress™ 2022 include:
June 23rd 9:00 – 18:30 BST
June 24th 9:00 – 18:00 BST
June 25th 9:00 AM BST
Congress attendees can visit CymaBay throughout the meeting at booth 93.
A full list of presentations can be found on The International Liver Congress ™ 2022 website.
The presentations will be made available on the CymaBay website.
For additional information about CymaBay visit www.cymabay.com.
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