Gilead Presents Data on Multiple Investigational Regimens for the Treatment of Patients With Nonalcoholic Steatohepatitis (NASH) and Advanced Fibrosis at The International Liver Congress™ 2018

Gilead Sciences, Inc. (Nasdaq: GILD) today presented data from a proof-of-concept study of investigational combination therapies for patients with advanced fibrosis due to nonalcoholic steatohepatitis (NASH), combining the apoptosis signal-regulating kinase 1 (ASK1) inhibitor selonsertib with either the Acetyl-CoA carboxylase (ACC) inhibitor GS-0976 or the selective, non-steroidal Farnesoid X receptor (FXR) agonist GS-9674. The data were presented at The International Liver Congress™ 2018 in Paris.

More than 25 additional Gilead abstracts on NASH and other fibrotic liver diseases are also being presented, including data from predictive modeling studies using noninvasive tests for the diagnosis and monitoring of NASH that aim to reduce the need for liver biopsy.

“Gilead is focused on addressing the greatest unmet need in NASH, which is in patients with advanced fibrosis. Reflective of this unmet need, the STELLAR-3 and STELLAR-4 studies of selonsertib in patients with F3 and F4 fibrosis have completed enrollment ahead of schedule. We expect data from these Phase 3 studies in the first half of 2019,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “We are now exploring combination therapy approaches with compounds with distinct and potentially complementary mechanisms of action. The initial data presented today are important advances toward our goal of improving outcomes for patients with advanced fibrosis due to NASH.”

Investigational Combination Therapies in Patients with NASH

The proof-of-concept study (Oral #105) included 70 patients treated with either selonsertib 18 mg plus GS-0976 20 mg (n=20), selonsertib 18 mg plus GS-9674 30 mg (n=20), or each monotherapy (n=10 per group) once daily for 12 weeks. All patients in the study were diagnosed with NASH and liver fibrosis stages F2 to F3 based on biopsy, or by magnetic resonance elastography (MRE) and MRI proton density fat fraction (MRI-PDFF). The greatest changes observed after 12 weeks of treatment in the study were decreases in liver fat content (measured by MRI-PDFF), which occurred in regimens containing GS-0976. Improvements in liver biochemistry and/or markers of fibrosis were also observed across both combination arms of the study compared to baseline. In patients treated with selonsertib plus GS-0976, kinetic labeling revealed the largest reduction in the fractional synthesis rate of lumican, a marker of fibrogenesis. Similar rates of adverse events were observed between patients treated with single-agent and combination therapies. No patient discontinued treatment prematurely.