Bristol-Myers Squibb (BMS) has reported positive results from a Phase II clinical trial of BMS-986036 to treat non-alcoholic steatohepatitis (NASH) patients.
BMS-986036 is an investigational pegylated analogue of human fibroblast growth factor 21 (FGF21).
The results from the randomised, multi-centre, double-blind, placebo-controlled, parallel group, multiple-dose Phase II trial showed that the product has met the primary endpoint of significant reduction in liver fat compared to placebo.
The trial assessed the safety, pharmacodynamics and pharmacokinetic effects of the product in 74 adults with biopsy-confirmed NASH.
Bristol-Myers Squibb cardiovascular, fibrosis and immunoscience development head Mike Burgess said: “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.
“This data, along with previously announced Phase II data in patients with type 2 diabetes, supports further clinical research of BMS-986036 as a potential treatment for NASH."
The trial evaluated subcutaneous injections of BMS-986036 at 10mg per day over a period of 16 weeks.
The primary endpoint of the trial was total change in MRI-PDFF at week 16, while the exploratory endpoints included measure of serum Pro-C3, enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and liver stiffness.
It was observed that there was statistically significant improvement in the prespecified exploratory endpoints and the safety profile was also found to be encouraging.
Ambrx licenced the exclusive research, development and commercialisation rights of BMS-986036 to BMS.