Gilead Presents New Data in Nonalcoholic Steatohepatitis (NASH) at the International Liver Congress™ 2019
Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from the company’s clinical research program in nonalcoholic steatohepatitis (NASH) being presented at The International Liver Congress™ 2019 in Vienna. The data support Gilead’s efforts to develop combination therapies to target different aspects of NASH, evaluate the utility of noninvasive tests for the identification of patients living with the disease and advance overall understanding of the complexities and burden of NASH.
“NASH is a complex disease with multiple biological pathways that influence its progression. Combination therapeutic approaches which target these pathways, are likely to be needed to effectively treat patients living with NASH, particularly those with advanced fibrosis who have the greatest unmet need,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. “We are encouraged by the results of our proof-of-concept study being presented this week and look forward to sharing further combination data from the Phase 2 ATLAS trial later this year.”
Combination Therapy Treatment for NASH
A proof-of-concept study demonstrated that the combination of the investigational, selective, non-steroidal farnesoid X receptor (FXR) agonist cilofexor (GS-9674) and the acetyl-CoA carboxylase (ACC) inhibitor firsocostat (GS-0976) resulted in improvements in hepatic steatosis, liver stiffness, liver biochemistry and serum fibrosis markers. In the study, 20 patients with NASH received cilofexor 30 mg and firsocostat 20 mg orally once daily for 12 weeks. A significant decline of at least 30 percent in hepatic fat measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) from baseline to 12 weeks was observed in 74 percent of patients. Improvements in liver biochemistry tests including serum ALT (median relative reduction, -37%; p<0.001) and GGT (-32%; p<0.001), along with markers of reduced bile acid synthesis, were observed at 12 weeks. Treatment was well tolerated and pruritus was not reported in any patients. Asymptomatic, Grade 3 hypertriglyceridemia was observed in two patients. No patients withdrew from the study due to adverse events.
Liver biopsy is currently the reference standard to identify patients with NASH but is an invasive and costly procedure with potential for serious complications. Gilead will present an analysis of screening data from its Phase 2 ATLAS study evaluating combinations of investigational cilofexor, firsocostat and selonsertib in advanced fibrosis due to NASH.
This analysis demonstrates that the use of currently available noninvasive tests (NITs) can accurately identify patients with advanced fibrosis due to NASH and potentially reduce the need for liver biopsy. When used in combination, the Enhanced Liver Fibrosis (ELF) test and FibroScan® accurately identified advanced fibrosis in >80 percent of patients.
Cilofexor and firsocostat, alone or in combination, are investigational compounds and are not approved by the U.S. Food & Drug Administration (FDA) or any other regulatory authority. Safety and efficacy have not been established for these agents.
Burden of Disease and Patient-Reported Outcomes
While NASH can have non-specific symptoms, research is needed to understand the impact of disease on quality of life for those living with the condition, measured through patient-reported outcomes (PROs). Baseline data from the STELLAR Phase 3 trials showed significant burden of disease among people with advanced fibrosis due to NASH. In 1,667 patients enrolled in the STELLAR trials, PROs assessed using tools including the Chronic Liver Disease Questionnaire (CLDQ-NASH) prior to treatment, particularly those related to physical health-related scores, were significantly lower than those of population norms. In another analysis of patients enrolled in the STELLAR program, diabetes mellitus was associated with impairment in PROs including physical functioning, bodily pain, general health and vitality. An additional study assessing health-related quality of life in 1,338 patients with advanced fibrosis due to NASH demonstrated that these individuals have more impairment of their physical health-related scores than patients with chronic hepatitis C virus.
About Gilead’s Clinical Programs in NASH
NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, that impairs liver function. Individuals living with fibrosis are at a significantly higher risk of liver-related mortality and all-cause mortality.
Gilead is advancing multiple novel investigational compounds for the treatment of advanced fibrosis due to NASH, evaluating single-agent and combination therapy approaches against the core pathways associated with NASH – hepatocyte lipotoxicity, inflammation and fibrosis. Investigational compounds in development include the ASK1 inhibitor selonsertib, the selective, non-steroidal FXR agonist cilofexor (GS-9674) and the ACC inhibitor firsocostat (GS-0976). The STELLAR-3 Phase 3 trial evaluating selonsertib among NASH patients with bridging fibrosis (F3) is ongoing. Cilofexor and firsocostat are currently in Phase 2 studies in NASH, including the ATLAS trial evaluating combinations of selonsertib, cilofexor and firsocostat in advanced fibrosis (F3 and F4) due to NASH.
Selonsertib is an investigational compound and is not approved by the U.S. Food & Drug Administration (FDA) or any other regulatory authority.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.
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 clinical trial programs evaluating single-agent and combination therapy approaches, including selonsertib, cilofexor and/or firsocostat, 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, cilofexor and/or firsocostat 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, 2018, 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.
Sung Lee, Investors
Arran Attridge, Media
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Gilead Sciences to Release Second Quarter 2019 Financial Results on Tuesday, July 30, 201916.7.2019 20:05:00 CEST | Press release
Gilead Sciences, Inc. (Nasdaq: GILD) announced today that its second quarter 2019 financial results will be released on Tuesday, July 30, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s financial results for the second quarter 2019 and provide a business update. The live webcast of the call can be accessed at the company’s Investors page at http://investors.gilead.com/. Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 8696029 to access the call. Telephone replay will be available approximately two hours after the call through 8:00 p.m. Eastern Time, August 1, 2019. To access the replay, please call 855-859-2056 (U.S.) or 404-537-3406 (international) and dial the confere
MSCI Schedules Investor Conference Call to Review Second Quarter 2019 Results16.7.2019 14:49:00 CEST | Press release
MSCI Inc. (NYSE: MSCI), a leading provider of critical decision support tools and services for the global investment community, announced today it will release its results for second quarter 2019 on Thursday, August 1, 2019. MSCI's senior management will review the second quarter 2019 results on Thursday, August 1, 2019 at 11:00 AM Eastern Time. To listen to the live event, visit the events and presentations section of MSCI's Investor Relations homepage, http://ir.msci.com/events.cfm, or dial 1-877-376-9931 conference ID: 7743929 within the United States. International callers dial 1-720-405-2251 conference ID: 7743929. The earnings release and related investor presentation used during the conference call will be made available on MSCI's Investor Relations homepage. An audio recording of the conference call will be available on our Investor Relations website, http://ir.msci.com/events.cfm, beginning approximately two hours after the conclusion of the live event. Through August 4, 2019,
Keio Plaza Hotel Tokyo Offers “Tea Ceremony Experience and Luxurious Accommodations for Families” Package16.7.2019 14:05:00 CEST | Press release
Keio Plaza Hotel Tokyo (KPH), one of Japan’s most prestigious international hotels located in Shinjuku, Tokyo, will begin offering a special summer accommodation package entitled “Tea Ceremony Experience and Luxurious Accommodations for Families” from July 20 to September 1, 2019. This accommodation package has been specially designed to keep families with children entertained by providing the unique cultural experience of a Japanese tea ceremony as fond memories of their summer vacation at our Hotel. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190716005325/en/ With the accommodation package, guests with children could experience unique cultural Japanese tea ceremony to learn how to make a green tea and its history. (Photo: Business Wire) The rooms offered in this accommodation package are the very popular “Two Queen Beds Rooms” located on the “Premier Grand” club floors with use of the Club Lounge included. The rooms are
Andersen Global Enters Senegal, Expands Presence in Africa16.7.2019 13:30:00 CEST | Press release
Andersen Global is proud to announce a collaboration agreement with Cabex, one of the oldest legal and tax consulting firms in Senegal. Senegal thus becomes the thirteenth African country where Andersen Global has a member or collaborating firm offering legal services. Located in Dakar, Cabex has been offering services to local and foreign clients from the public and para-public sectors on matters relating to national and international issues for nearly thirty years. “Collaborating with Andersen Global shall expand our international scope and our transborder capabilities while giving us additional opportunities to expand into new markets,” Papa Alassane Ndir, Partner & General Manager at Cabex, said. “Henceforth, we are going to collaborate with many colleagues and experts from around the world and will be in a position to provide our clients more in-depth expertise.” Cherif Diaite, Partner & Technical Manager at Cabex, indicated that, “Owing to the challenge at an international level,
Mercatus Opens UK Office; Hires Chris Webb to Lead European Operations16.7.2019 13:00:00 CEST | Press release
Mercatus, a leading asset and investment management platform for alternative investors and asset managers, today announced the opening of its European Headquarters in London, UK and the addition of Chris Webb as Senior Director leading the office in London. Chris was formerly a Global Director of Strategic Business Growth at FIS, with a deep focus on, and expertise in, alternative investments. “As Alternative fund managers and investors across Europe continue to embrace technology – and data – as a competitive weapon to drive future accelerated growth, we’re putting our resources in some of the largest markets. Our London office will be a critical hub for our workings in the UK, expanding upon our other offices in Silicon Valley, New York, Austin, Rome and Pune, India,” said Haresh Patel CEO of Mercatus. “We will continue to expand our local presence across Europe and Asia as our customers have deal and asset management teams in 118 countries with $540B AUM operating within the Mercatu
LivaNova Combats Leg Ischemia with Breakthrough Bidirectional Cannula16.7.2019 13:00:00 CEST | Press release
LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today launched its innovative arterial femoral cannula, Bi-Flow, designed to prevent limb ischemia during cardiac surgery. LivaNova Bi-Flow received CE Mark earlier this year and is the only bidirectional arterial cannula designed to prevent leg ischemia during cardiac surgery procedures requiring femoral artery cannulation. In a clinical study, Bi-Flow was easily inserted and removed without complications and was proven to provide simultaneous systemic and distal perfusion of the limb in a safe and reproducible way.1 Leg ischemia is caused by compromised blood flow to a lower limb and can affect up to 11% of patients undergoing complex cardiac surgery procedures.2 Consequences can include higher mortality, higher morbidity and longer hospital stays.3 The first procedure in Europe using a Bi-Flow cannula was performed by Patrick Perier M.D., FACS, at the Cardiovascular Center of Bad Neustadt, Germany. “I truly bel