Gilead Presents Proof-of-Concept Data for GS-0976 in Nonalcoholic Steatohepatitis (NASH) at The International Liver Congress™ 2017
Gilead Sciences, Inc. (Nasdaq:GILD) today announced results from an open-label, proof-of-concept study evaluating GS-0976, an investigational inhibitor of Acetyl-CoA carboxylase (ACC), in patients with nonalcoholic steatohepatitis (NASH). The data, from ten patients treated with GS-0976 20 mg taken orally once daily for 12 weeks, indicated that treatment was associated with statistically significant improvements in liver fat content and noninvasive markers of fibrosis, via inhibition of hepatic de novo lipogenesis (DNL). The late-breaking data were presented today during a general session at The International Liver Congress™ 2017 in Amsterdam (#GS-009).
“The identification of novel strategies for reducing liver fibrosis is a core focus in the development of therapies for patients with NASH,” said Eric J. Lawitz, MD, lead study author and Vice President of Scientific and Research Development, Texas Liver Institute and Clinical Professor of Medicine, University of Texas Health, San Antonio. “We know that elevated DNL is a major contributor to the pathogenesis of NASH and these data suggest that decreasing DNL through inhibition of ACC can lead to significant reductions in both liver fat content and stiffness, with early decreases in markers of liver fibrosis.”
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 NASH are also being presented at The International Liver Congress demonstrating that GS-0976 reduces hepatic steatosis, liver biochemistry and the expression of pro-fibrotic and pro-inflammatory genes in the liver (#FRI-352).
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 NASH is ongoing. ACC catalyzes the first step in DNL, the synthesis of fatty acids that contributes to hepatic steatosis (fatty infiltration) and, subsequently, inflammation and liver fibrosis. ACC also regulates beta oxidation, the burning of fat by hepatic mitochondria.
NASH is a chronic liver disease associated with steatosis, or accumulation of fat within the liver, that can lead to inflammation, progressive fibrosis and cirrhosis. The median survival for a NASH patient with cirrhosis (F4) is approximately five years.
About Gilead’s Clinical Programs in NASH
Gilead is advancing multiple novel investigational compounds for the treatment of NASH with advanced fibrosis. Gilead is currently planning or conducting Phase 2 and Phase 3 clinical trials evaluating single-agent and combination therapy approaches against multiple core pathways associated with NASH – metabolic dysregulation, inflammation and fibrosis. Compounds in development include the apoptosis signal-regulating kinase 1 (ASK1) inhibitor, selonsertib; the selective, non-steroidal Farnesoid X receptor (FXR) agonist, GS-9674; and GS-0976, an inhibitor of ACC. Phase 3 trials evaluating selonsertib among NASH patients with bridging fibrosis (F3) or cirrhosis (F4) are ongoing (the STELLAR program). GS-9674 and GS-0976 are currently in Phase 2 NASH studies.
Selonsertib, GS-9674 and GS-0976, alone and in combination, are investigational therapies and have not been determined to be safe or efficacious.
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 30 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 GS-0976, selonsertib and GS-9674 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 GS-0976, selonsertib and GS-9674 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, 2016, 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 (Investors)
Nathan Kaiser, 650-522-1853 (Media)
Om 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.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
H.I.G. Capital Announces the Sale of KidsFoundation19.7.2018 19:50 | Pressemelding
H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €21 billion of equity capital under management, announced today that one of its affiliates has entered a definitive agreement to sell the KidsFoundation Group (“KidsFoundation”), the Dutch market leader in childcare services, to Onex Corporation (“Onex”)(TSX:ONEX). Terms were not disclosed. Headquartered in Almere, the Netherlands, KidsFoundation provides high-quality childcare to nearly 30,000 children between the ages of six weeks and 12 years. H.I.G. created KidsFoundation in 2014 through the acquisition of assets from the estate of Estro Group. During H.I.G.’s ownership, the company has developed strongly with significant capital invested by H.I.G. to create a high-quality childcare offering. H.I.G. worked with KidsFoundation management to optimise the footprint of the company by exiting loss-making locations, introduce new IT systems to drive operational improvement and develop an internal M&
SIG Combibloc Group Holdings S.à r.l.: 2018 Second Quarter Results19.7.2018 16:01 | Pressemelding
We are pleased to announce our quarterly conference call to discuss the results of SIG Combibloc Group Holdings S.à r.l. for the second quarter ended June 30, 2018. Date: Monday, July 23, 2018 Time: 15.00 CEST / 14.00 BST / 9.00 EDT The call information will be distributed on our secure site. If you would like access to our call, please contact firstname.lastname@example.org . Regards, SIG Combibloc Group Holdings S.à r.l. View source version on businesswire.com: https://www.businesswire.com/news/home/20180719005634/en/ Contact information SIG Combibloc Group Holdings S.à r.l. Jennifer Gough email@example.com
NEORIS Announces Creation of Innovation Labs Worldwide to Create a Smarter Future19.7.2018 15:32 | Pressemelding
NEORIS, a global digital consulting services company, announced today it is consolidating the most innovative solutions it has developed in different geographies and allocating unprecedented resources to deploy a network of Innovation Labs worldwide. The main objective is to lay the foundation for the continuous development of disruptive solutions for its four core industries: Manufacturing, Financial Services, Healthcare and Telecommunications. Due to its disruptive nature, NEORIS decided that its first Innovation Lab should be housed in the Monterrey Digital Hub, which today is the first-of-its-kind as it is a space where entrepreneurs, companies, universities and investors converge to foster an ecosystem for Digital Transformation. The lab inaugurated in Monterrey, Mexico is the first of a series of Innovation Labs that will open in the different countries that NEORIS operates, and is a space where customers can experience emerging technologies through real-life scenarios. One such
CORRECTING and REPLACING Albar Capital Deploys FlexNOW19.7.2018 15:29 | Pressemelding
Subhead of release should read: Out-of-the-Box Multi-Asset Execution Management System (instead of Easy-to-Install Multi-Asset Execution Management System). The corrected release reads: ALBAR CAPITAL DEPLOYS FLEXNOW Out-of-the-Box Multi-Asset Execution Management System FlexTrade (@FlexTrade) today announced that Albar Capital Ltd., a new hedge fund led by Javier Velazquez (formerly of Millennium Capital Partners LLP), is now trading equities and futures using FlexNOW, FlexTrade’s new execution management system. “The FlexNOW team was instrumental in solving several of our problems,” said Jason Ruder, Trader at Albar Capital. “Not only are they helping us with our compliance requirements, they are also responsive to requests that improve my workflow.” According to Rhyd Lewis, FlexNOW Product Manager, FlexNOW’s quick onboarding and easy installation process was critical for Albar Capital’s launch on 2 July. “We had no problem integrating FlexNOW with Albar’s portfolio and risk managemen
Full Core of Westinghouse Fuel Achieved at South-Ukraine Nuclear Power Plant Unit 319.7.2018 13:25 | Pressemelding
Westinghouse Electric Company announced today that Ukraine’s State Enterprise National Nuclear Energy Generation Company (SE NNEGC) Energoatom’s South-Ukraine NPP Unit 3 near Yuzhnoukrainsk in Mykolaiv province was loaded with a full core of Westinghouse VVER-1000 fuel. This is the first unit in Ukraine to operate with Westinghouse VVER-1000 fuel assemblies as the sole fuel source. “Westinghouse began supplying fuel to Ukraine in 2005, when the first lead test assemblies were delivered to South-Ukraine Unit 3,” said Aziz Dag, vice president and managing director, Northern Europe. “We are proud to continue supporting Ukraine with their energy diversification by supplying a full core of Westinghouse VVER-1000 fuel to our customer, Energoatom.” Westinghouse currently supplies fuel to six of Ukraine’s 15 nuclear power reactors. Beginning in 2021, the number of reactors with Westinghouse fuel will increase to seven. “Westinghouse has made significant investments over the last several years
Seoul Semiconductor Delivers Its Innovative LED "SunLike" to U.S. Lighting Market19.7.2018 13:00 | Pressemelding
Seoul Semiconductor Co., Ltd. (KOSDAQ:046890), a market leader in LED (light emitting diode) design and manufacturing, announced that its innovative LED “SunLike” is applied to brand new lightings to be launched by three lighting premium brands in U.S., Pure Edge Lighting, LEDRAbrands, Inc. and Elite Lighting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180719005377/en/ The product of LEDRAbrands, Inc., NU4RA-SUN, which applied SunLike of Seoul Semiconductor (Photo: Business Wire) Seoul Semiconductor supplies SunLike to pendant lighting for Pure Edge, a U.S. lighting solution company. It is applied to high-end lighting for museums and art galleries that require the highest color quality. The leading lighting design companies, LEDRAbrands, Inc. and Elite Lighting, apply SunLike to downlights and spotlights respectively. “We have selected Seoul Semiconductor’s innovative LED SunLike for our human centric lighting and believ