|View printer-friendly version|
|Gilead Presents Proof-of-Concept Data for GS-0976 in Nonalcoholic Steatohepatitis (NASH) at The International Liver Congress™ 2017|
-- 12-Week Results with the Investigational ACC Inhibitor Show Inhibition of De Novo Lipogenesis and Significant Reductions in Liver Fat and Stiffness --
“The identification of novel strategies for reducing liver fibrosis is a
core focus in the development of therapies for patients with NASH,” said
Based on a novel approach involving the labeling of newly synthesized palmitate by deuterated water administration, patients receiving GS-0976 experienced a median decrease of 29 percent in hepatic DNL from baseline after 12 weeks. At week 12, patients receiving GS-0976 experienced a 43 percent median relative decrease in liver fat content, from 15.7 percent to 9.0 percent (p=0.006), as measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). Median liver stiffness, a noninvasive marker of fibrosis, declined from 3.4 to 3.1 kPa at week 12 (p=0.049), as assessed by magnetic resonance elastography (MRE). In addition, patients with reductions in hepatic fat demonstrated improvements in liver biochemistry and serum markers of fibrosis and apoptosis, supporting the biological activity of GS-0976.
All adverse events were Grade 1 or 2 in severity. No patients prematurely discontinued study medication.
Preclinical data from a mouse model of
GS-0976 is an investigational therapy and has not been determined to be safe or efficacious.
A separate Phase 2, randomized, double-blind, placebo-controlled trial
evaluating GS-0976 in 125 patients with
About Gilead’s Clinical Programs in
Gilead is advancing multiple novel investigational compounds for the
Selonsertib, GS-9674 and GS-0976, alone and in combination, are investigational therapies and have not been determined to be safe or efficacious.
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company’s mission is to advance the care of patients suffering
from life-threatening diseases. Gilead has operations in more than 30
countries worldwide, with headquarters in Foster City,
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including Gilead’s
ability to complete its Phase 2 and Phase 3 clinical trial programs
evaluating GS-0976, selonsertib and GS-9674 in patients with
For more information on
Gilead Sciences, Inc.
Minimum 20 minute delay