EASL: Bristol-Myers' drug cuts liver fat in NASH
- In a late-breaking oral presentation on Saturday at the International Liver Congress (EASL), held in the Netherlands, Bristol-Myers Squibb unveiled Phase 2 data from the study of BMS-986036, its pegylated analog of human fibroblast growth factor (FGF21).
- In overweight patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH), 10mg daily or 20mg weekly treatment with BMS-986036 significantly reduced fat in the liver, its primary endpoint, at week 16, by 6.8% and 5.2%, respectively, compared with 1.3% in the placebo group. In the daily group, 57% of patients reached 30% or greater risk reduction, and in the weekly group, this was reached by 52% of patients.
- Both treatment groups had significantly improved markers of fibrosis and liver injury (pre-specified exploratory endpoints), and all treated patients showed improved triglycerides, low density lipoprotein (LDL) and high density lipoprotein (HDL).
Bristol-Myers Squibb signed up to a collaboration with Ambrx in 2011 to develop biologics targeting FGF-21, and holds exclusive rights to BMS-986036 (previously known as ARX618) from this collaboration. FGF-21 is a key regulator of metabolism, and BMS-986036 has also been studied in type 2 diabetes.
"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, Bristol-Myers Squibb.
Bristol-Myers is planning discussions with the regulatory authorities in order to discuss the next step. NASH affects around 20 million people in the U.S., and while there are no treatments for NASH currently, that looks set to change. The NASH space has become particularly hot in the last few years as companies that once focused on hepatitis C have shifted gears to focus on this new liver disease after a cure was found for the former. A number of companies, including NGM Biopharmaceuticals, Allergan and Novartis, Intercept Pharmaceuticals and Cempra are all lining up potential agents in Phase 2 and Phase 3.
- Bristol-Myers Squibb Press release
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