Gilead reports mixed Phase II data for NASH candidate

Gilead Sciences Inc. (NASDAQ:GILD) reported data from a Phase II trial of GS-0976 to treat non-alcoholic steatohepatitis (NASH) showing that the higher of 2 doses of the compound significantly reduced liver fat content and a marker of fibrosis compared to placebo. The lower dose did not show a significant improvement on any efficacy endpoint. In 2016, Gilead paid $400 million up front to obtain the allosteric acetyl-coenzyme A carboxylase (ACAC; ACC) inhibitor from Nimbus Therapeutics LLC (Cambridge, Mass.) (see BioCentury, April 11, 2016).

In the 126-patient trial, patients received placebo or once-daily 5 or 20 mg oral GS-0976 for 12 weeks. High-dose GS-0976 significantly reduced median liver fat content as measured by MRI proton density fat fraction (MRI-PDFF) from baseline to week 12 by 28.9% vs. 8.4% for placebo (p=0.002). Additionally, a significantly greater proportion of patients who received high-dose GS-0976 had a ≥30% reduction in MRI-PDFF vs. placebo (48% vs. 15%, p=0.004). The high-dose also significantly reduced median levels of tissue inhibitor of metalloproteinases 1 (TIMP1), a serum marker associated with liver fibrosis, by 7.9% vs. 1.5% for placebo (p=0.022)...