Primary endpoint of significant reduction in liver fat achieved following 16 weeks of treatment with BMS-986036.

Bristol-Myers Squibb (BMS) has announced data from a Phase II study of BMS-986036, an investigational pegylated analogue of human fibroblast growth factor 21 (FGF21), a key regulator of metabolism, in patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) (F1-F3). The study achieved its primary endpoint of significant reduction in liver fat versus placebo. Statistically significant improvements were also seen in prespecified exploratory endpoints including biomarkers of fibrosis, metabolic parameters and markers of liver injury.

"These data suggest that BMS-986036 may be effective in patients with NASH, many of whom will experience disease progression due to the lack of available treatment options," said Arun Sanyal, MBBS, professor, Departments of Medicine, Physiology, and Molecular Pathology, Virginia Commonwealth University. "The results of this study show that BMS-986036 had beneficial effects on three important components in the treatment of NASH: liver fat, liver injury and fibrosis."

"We are encouraged by the improvements these data showed across multiple aspects of NASH, and that patients could be effectively evaluated through imaging rather than through invasive liver biopsy," said Mike Burgess, head of Cardiovascular, Fibrosis and Immunoscience Development, BMS. "These data, along with previously announced Phase II data in patients with type 2 diabetes, support further clinical research of BMS-986036 as a potential treatment for NASH. We look forward to sharing these data with health authorities to determine next steps for further study of this asset."