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Posted On: 11/25/2019 8:43:35 AM
Post# of 148878
Another failure in NASH
NEWARK, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (CYMA) (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that the company was terminating its Phase 2b study of seladelpar in subjects with non-alcoholic steatohepatitis (NASH) and its recently initiated Phase 2 study of seladelpar in subjects with primary sclerosing cholangitis (PSC). In addition, the company is putting on hold all studies of seladelpar in subjects with primary biliary cholangitis (PBC).
The decision to halt development of seladelpar was based on initial histological findings observed in the Phase 2b study of seladelpar in NASH. Planned, blinded histological assessments of the first tranche of liver biopsies in the trial revealed atypical histological findings, including histology characterized as an interface hepatitis presentation, with or without biliary injury. The company has initiated a series of investigative actions to better understand these findings.
“The atypical histological findings in the NASH Phase 2b clinical study of seladelpar were observed in patients who demonstrated on-study improvement or stabilization of their biochemical measures of inflammation and liver injury and no liver-related adverse events after 52 weeks of treatment,” stated Sujal Shah, CEO of CymaBay. “These findings were also unexpected based on our preclinical and clinical experience with seladelpar to date. However, in light of the findings, we have decided to terminate our NASH and PSC studies and place our PBC studies on hold pending further review and follow-up. We are very disappointed in having to halt the development of seladelpar at this time but patient safety and care is paramount. We would like to thank patients and their families, as well as the investigators and site personnel that have participated in these studies.”
NEWARK, Calif., Nov. 25, 2019 (GLOBE NEWSWIRE) -- CymaBay Therapeutics, Inc. (CYMA) (Nasdaq: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, today announced that the company was terminating its Phase 2b study of seladelpar in subjects with non-alcoholic steatohepatitis (NASH) and its recently initiated Phase 2 study of seladelpar in subjects with primary sclerosing cholangitis (PSC). In addition, the company is putting on hold all studies of seladelpar in subjects with primary biliary cholangitis (PBC).
The decision to halt development of seladelpar was based on initial histological findings observed in the Phase 2b study of seladelpar in NASH. Planned, blinded histological assessments of the first tranche of liver biopsies in the trial revealed atypical histological findings, including histology characterized as an interface hepatitis presentation, with or without biliary injury. The company has initiated a series of investigative actions to better understand these findings.
“The atypical histological findings in the NASH Phase 2b clinical study of seladelpar were observed in patients who demonstrated on-study improvement or stabilization of their biochemical measures of inflammation and liver injury and no liver-related adverse events after 52 weeks of treatment,” stated Sujal Shah, CEO of CymaBay. “These findings were also unexpected based on our preclinical and clinical experience with seladelpar to date. However, in light of the findings, we have decided to terminate our NASH and PSC studies and place our PBC studies on hold pending further review and follow-up. We are very disappointed in having to halt the development of seladelpar at this time but patient safety and care is paramount. We would like to thank patients and their families, as well as the investigators and site personnel that have participated in these studies.”
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