Business Wire

Gilead Presents New Data Highlighting Progress in Liver Fibrosis


Gilead Sciences, Inc. (NASDAQ:GILD) today announced data supporting the development of three investigational agents for the treatment of nonalcoholic steatohepatitis (NASH) and primary sclerosing cholangitis (PSC). The data were presented in oral and poster sessions at The International Liver CongressTM 2016 in Barcelona, Spain.

NASH is a serious liver disease resulting from metabolic dysfunction that is associated with steatosis (fat within the liver), inflammation and fibrosis, which may progress to cirrhosis. NASH-related cirrhosis is expected to become the leading indication for liver transplantation by 2020. PSC is a disease characterized by inflammation and stricturing of the bile ducts. PSC can eventually lead to cirrhosis and other complications, including bile duct cancer.

“The data presented enhance our understanding of the pathogenesis of NASH and PSC – two progressive liver diseases for which there are no approved treatment options,” said Norbert Bischofberger, PhD, Executive Vice President of Research and Development and Chief Scientific Officer at Gilead. “We are committed to advancing the treatment of NASH and PSC by targeting multiple core pathways associated with metabolic dysfunction, inflammation and fibrosis. We are encouraged by the data presented at EASL and look forward to applying the scientific insights from these and other ongoing studies to enhance our clinical programs.”


Simtuzumab is a monoclonal antibody that is selective for lysyl oxidase-like-2 (LOXL2), an extracellular matrix enzyme that promotes fibrosis via the cross-linkage of collagen fibers. Gilead is evaluating simtuzumab for the treatment of fibrosis in patients with NASH and PSC in three ongoing Phase 2b clinical trials.

Data evaluating the associations between clinical features, liver histology and portal pressure at baseline in patients with NASH and PSC were presented in multiple poster sessions (Poster THU-016, Poster THU-369, Poster FRI-324, Poster FRI-350, Poster FRI-375 and Poster SAT-400). The data support the correlations between PSC-related liver fibrosis assessed histologically and noninvasive markers (e.g., serum levels of LOXL2 and liver stiffness by transient elastography).

An additional study presented during an oral session identified novel genetic polymorphisms associated with liver fibrosis and serum levels of LOXL2 in patients with PSC, which may help identify patients with an increased risk of disease progression (Oral PS-093).

These studies were led by Christopher Bowlus, MD, University of California, Davis, Sacramento, California (FRI-375); Zachary Goodman, MD, PhD, Inova Fairfax Hospital, Falls Church, Virginia (SAT-400); Andrew Muir, MD, Duke Clinical Research Institute, Durham, North Carolina (FRI-350); Arun Sanyal, MD, Virginia Commonwealth University, Richmond, Virginia (THU-016); and Patrick Shea, PhD, Institute for Genomic Medicine at Columbia University, New York, New York (THU-369; FRI-324; Oral PS-093).

Topline safety and efficacy data from the Phase 2b studies of simtuzumab for the treatment of NASH and PSC are anticipated by the end of 2016.


GS-4997 is a small-molecule inhibitor of apoptosis signal-regulating kinase 1 (ASK1), which promotes inflammation, apoptosis and fibrosis in settings of increased oxidative stress associated with NASH pathogenesis. GS-4997 is currently being evaluated in an ongoing Phase 2 study in patients with NASH and moderate to severe liver fibrosis.

Results from a Gilead-led preclinical study presented during an oral session (Oral PS-070) demonstrate that GS-444217, a related ASK1 inhibitor, significantly reduced hepatic steatosis, inflammation, fibrosis, serum cholesterol and insulin resistance in mice fed a diet high in fat, cholesterol and sugar. In addition, ASK1 inhibition led to significant changes in plasma metabolites related to bile acid and lipid metabolism.


GS-9674 is 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. Results from two preclinical studies selected for oral presentation highlight the therapeutic efficacy of GS-9674 in animal models of NASH. In a Gilead-led study, a diet-induced obesity model demonstrated that mice administered GS-9674 had reduced hepatic steatosis and fibrosis, as well as serum levels of cholesterol, ALT and AST compared with untreated animals (Oral PS-066).

In a second study, presented by Philipp Schwabl, MD, and led by Michael Trauner, MD, both of the Division of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria, rats were administered sodium nitrate and fed a choline-deficient, high-fat diet for 10 weeks that resulted in cirrhosis and portal hypertension. Data demonstrate that GS-9674 treatment had dose-dependent anti-fibrotic effects and lowered portal pressure (Oral PS-058). The results of these pre-clinical studies support the evaluation of GS-9674 in patients with NASH following completion of an ongoing Phase 1 study.

Acetyl-CoA Carboxylase (ACC) Inhibitor NDI-010976

As announced on April 4, Gilead entered into an agreement to acquire the Acetyl-CoA Carboxylase (ACC) inhibitor program from Nimbus Therapeutics, which includes the clinical compound NDI-010976 and a number of other preclinical ACC inhibitors for the potential treatment of NASH, hepatocellular carcinoma (HCC) and other diseases. The acquisition is subject to certain closing conditions, including receipt of U.S. antitrust approval. Nimbus presented Phase 1 data (Oral PS-108) showing that NDI-010976 inhibited de novo lipogenesis in a dose-dependent fashion.

Further information about the clinical studies described above can be found at

Simtuzumab, GS-4997, GS-9674 and NDI-010976 are investigational products 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.

Forward-Looking Statement

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 the risk that Gilead may observe unfavorable results from additional clinical trials involving simtuzumab, GS-4997, GS-9674 and NDI-010976 and Gilead’s acquisition of Nimbus’s ACC inhibitor program may not be completed since the transaction is subject to closing conditions. In addition, Gilead may make a strategic decision to discontinue development of simtuzumab, GS-4997, GS-9674 and NDI-010976 if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. 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, 2015, 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 , follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000

Contact information

Gilead Sciences, Inc.
Patrick O’Brien, 650-522-1936
Cara Miller, 650-522-1616

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982

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

More than 70 Companies to Showcase Top Tech at CES Unveiled Paris20.10.2017 15:08Pressemelding

The Consumer Technology Association (CTA) today announced that more than 70 exhibitors will showcase their latest innovations at the now sold-out fifth annual CES Unveiled Paris The event will focus on the Internet of Things (IoT), connectivity and smart cities, and draw more than 600 attendees. CES Unveiled Paris will run from 2-7:30 PM on Tuesday, October 24, 2017 at the Palais Brongniart. Regional technology companies, top-tier media outlets, buyers and key industry influencers will come together at CES Unveiled Paris to get a direct look at the latest industry developments. The day kicks off with a CES news conference and CTA market trends presentation. Conference programming is followed by a tabletop exhibition & networking reception. Curated exhibitors will be there to showcase top tech from robotics and audio to smart home and augmented and virtual reality. Notable

Westinghouse Receives Regulatory Approval for Analysis Methodologies20.10.2017 12:15Pressemelding

Westinghouse Electric Company today announced that it has received approval from the U.S. Nuclear Regulatory Commission (NRC) for two new important analysis methodologies that will be used to upgrade Westinghouse- and Combustion Engineering-based nuclear steam supply system (NSSS) safety analyses. The approvals granted are for the new FULL SPECTRUMTM Loss of Coolant Accident (FSLOCATM) methodology and the Performance Analysis and Design Model software code update, PAD5. FSLOCA is capable of improved modeling of the transient response in a pressurized water reactor to the full spectrum of LOCA break sizes that could occur, and PAD5 is the next generation of the Westinghouse fuel rod design performance code. “These codes were developed to work in concert with each other to maximize analytical margin for nuclear utilities,” said Michele DeWitt, senior vice preside

Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread®20.10.2017 12:03Pressemelding

Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from Phase 2 and Phase 3 studies of its approved medicines for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection, adding to the body of evidence supporting Gilead’s viral hepatitis therapies in diverse patient populations. These and other data from more than 25 abstracts will be presented this week at The Liver Meeting® 2017, which begins today in Washington, D.C. Positive results from studies of Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in HCV-infected patients with severe renal impairment, Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) in HCV-infected liver transplant recipients and Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) in NS5A-inhibitor experienced HCV-infected patients will be presented during poster sessions on October 21 and October 22. In addition, updated results f

SP3H Announces That It Has Obtained a €1.2 Million European Union Grant for Its Intelligent and Clean Vehicle (VIP) Project20.10.2017 10:47Pressemelding

SP3H is proud to announce joining the very select circle of the 10 French winners of the H2020 SME Instrument Phase 2 program since 2014. This press release features multimedia. View the full release here: Last summer VIP received the very prestigious SME instrument phase 2 H2020 label in the "transport & smart cities mobility" category. With an overall budget of € 1.7 million, VIP is subsidized by the European Union at a rate of 70% or €1.2 million. The framework contract was officially signed early October. VIP is the pre-industrialization program for Fuelbox sensors, the world's first miniaturized scanner capable of analyzing the quality of fuels on board vehicles. The heart of the program remains closely linked to the reduction of CO2 and pollutant emissions from vehicle

Kennedy Wilson and Kennedy Wilson Europe Real Estate Plc Complete Merger, Creating $8 Billion Global Real Estate Company20.10.2017 10:00Pressemelding

Global real estate investment company Kennedy-Wilson Holdings, Inc. (NYSE:KW) (“KW”) today announced the completion of its merger with Kennedy Wilson Europe Real Estate Plc (LSE:KWE) (“KWE”). The transaction creates a leading global real estate investment and asset management platform with an $8 billion enterprise value. “This transformative combination with KWE represents an exciting new chapter for our company,” said William J. McMorrow, Chairman and CEO of KW. “We are moving towards a simplified corporate structure that provides more recurring income from stable property cash flows and greater upside potential from value-enhancing initiatives worldwide. We are well positioned for future growth and to continue our track record of generating attractive risk-adjusted returns on our invested capital.” “We are thrilled to combine the financial strength of KW and KWE to continu

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom