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
Currently, the diagnosis and monitoring of NASH requires liver biopsy, an invasive and costly procedure with the potential for serious complications. At the meeting, Gilead presented results from two studies utilizing machine learning techniques which suggest that noninvasive tests perform as effectively as liver biopsy for predicting clinical outcomes in patients with advanced fibrosis due to NASH. Both studies utilized data from two previous Phase 2b trials of simtuzumab that involved 477 NASH patients with F3-F4 fibrosis. While simtuzumab was ineffective, data from these trials have revealed important insights into the natural history of disease progression and the potential utility of noninvasive fibrosis markers.
One study (Poster #466) showed that models using noninvasive testing data can predict the risk of clinical disease progression in patients with advanced fibrosis due to NASH. Another study (Oral #178) identified models that can predict which patients are most likely to experience spontaneous fibrosis improvement. Both studies incorporated noninvasive tests such as Enhanced Liver Fibrosis (ELF) score, FIB-4 and NAFLD fibrosis score.
Additional presentations at The International Liver Congress™ describe the accuracy of other noninvasive markers, including proteomics (Poster #432), serum bile acids (Poster #422), micro-RNAs (Poster #463), and the stool microbiome (Poster #004) to predict liver histology and/or its change over time. These novel approaches will be evaluated in future Gilead studies.
About Gilead’s Clinical Programs in NASH
NASH is a chronic and progressive liver disease characterized by the accumulation of fat in the liver, as well as inflammation, which can lead to liver damage and fibrosis. Gilead is advancing multiple novel investigational compounds for the treatment of advanced fibrosis due to NASH.
Gilead is currently planning or conducting Phase 2 and 3 clinical trials evaluating single-agent and combination therapy approaches against multiple biologically relevant pathways associated with NASH – metabolic dysregulation, inflammation and fibrosis. Compounds in development include:
- Selonsertib (formerly GS-4997) – A small-molecule inhibitor of apoptosis signal-regulating kinase 1 (ASK1), which promotes inflammation, apoptosis and fibrosis in settings of increased oxidative stress, which is characteristic of NASH and associated with its pathogenesis.
- GS-9674 – A selective, non-steroidal agonist of the Farnesoid X receptor (FXR), a nuclear hormone receptor that is highly expressed in the gastrointestinal tract and liver. FXR is the primary regulator of bile acid synthesis and plays important roles in glucose and lipid metabolism.
- GS-0976 – A small-molecule inhibitor of Acetyl-CoA carboxylase (ACC), an enzyme that is involved in de novo lipogenesis, which is the synthesis of lipids, including mediators of inflammation and fibrosis. ACC also upregulates the burning of fat in the liver through beta oxidation.
Selonsertib, GS-9674 and GS-0976, alone and in combination, are investigational therapies and their efficacy and safety have not been determined.
About Gilead Sciences
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 35 countries worldwide, with headquarters in Foster City, California.
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 single-agent and combination therapy approaches, including selonsertib, and/or GS-9674 and/or GS-0976, in patients with NASH in the currently anticipated timelines or at all. In addition, there is the possibility of unfavorable results from further clinical trials involving these compounds. Further, it is possible that Gilead may make a strategic decision to discontinue development of selonsertib, and/or GS-9674 and/or GS-0976 if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. As a result, the compounds may never be successfully commercialized. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
For more information on Gilead Sciences, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000
Gilead Sciences, Inc.
Sung Lee, 650-524-7792
Arran Attridge, 650-425-8975
Source: Gilead Sciences, Inc.