Gilead Presents New Data Highlighting Progress in Liver Fibrosis
16.4.2016 10:30 | Business Wire
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 www.clinicaltrials.gov.
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.
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 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.
Patrick O’Brien, 650-522-1936
Cara Miller, 650-522-1616
Om Business Wire
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
The Valence Group Issues Fairness Opinion to SK Capital in Connection with Archroma18.8.2017 13:30 | Pressemelding
The Valence Group has provided a fairness opinion to SK Capital Partners, LP in connection with its recapitalization of Archroma, including investments made by various affiliates of SK Capital. Terms of the transaction were not disclosed. About SK Capital SK Capital is a private investment firm focused on the specialty materials, chemicals and pharmaceutical sectors. The firm builds strong and growing businesses that generate substantial long-term value for its investors. SK Capital utilizes its industry, operating and investment experience to identify opportunities to transform businesses into higher performing companies with improved strategic positioning, growth, profitability and risk profiles. The firm currently has approximately $1.9 billion of assets under management and its portfolio companies generate revenues of over $5.0 billion annually and employ approximat
Biker Summer 2017 campaign: What’s happening during Biker Summer 2017? Moto-tyres.co.uk is giving away exciting prizes!18.8.2017 09:22 | Pressemelding
Whether it’s a short weekend break or a long-distance tour – once again this year Moto-tyres.co.uk is asking bikers from 10 countries about their dream destinations and longest journeys as part of its “Biker Summer 2017” campaign. To ensure than nothing gets in the way of your next tour, the two-wheeler tyre store from Delticom, Europe’s leading online tyre dealer, is entering anyone who completes the survey before 30 September 2017 into a prize draw to win some great biking accessories. Simply answer three short questions about your plans for bike tours this year (don’t forget to provide your name and email address), and with a bit of luck, you might win one of these great prizes. Up for grabs are a GARMIN motorbike GPS system, a GoPro camera with helmet bracket and five 200-Pound vouchers for new motorbike tyres from the online store – thanks to the product range at Moto-tyres.co.uk, eve
Lenovo Continues to Gain Momentum in First Quarter FY 2017/1818.8.2017 00:04 | Pressemelding
Behind the strength of its 3-wave strategy, Lenovo’s business transformation continued to gain traction during the first quarter, delivering solid profitability in its core PC and smart devices business, and revenue and profit improvements in targeted growth areas, including the data center and mobile businesses. Fueled by new investments in people and products, Lenovo’s Data Center Group (DCG) introduced the most comprehensive product lineup in its history, with the new ThinkSystem and ThinkAgile portfolio, and continued to build out its end-to-end sales organization. Similarly, Lenovo’s Mobile Business Group launched significant new products led by the Moto Z2 Force, available now on all major U.S. carriers, and ramped up its branding efforts worldwide. “In the first quarter this fiscal year, we had stable performance as we executed our 3-wave strategy with commitment. We
Spirent Tests Wi-Fi Network Performance with O2 at the Coca-Cola London Eye17.8.2017 15:57 | Pressemelding
Spirent Communications plc (LSE:SPT), today announced its Landslide E10 network test platform has been used with O2 to validate the Wi-Fi network performance and capacity at the Coca-Cola London Eye, before the launch of a new smartphone application last month. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170817005758/en/ Spirent Landslide E10 helped O2 validate Wi-Fi performance and capacity at the Coca-Cola London Eye, before the launch of a new smartphone application last month. (Photo: Busines Wire) Merlin Entertainments plc, operator of the London Eye, wanted to measure its Wi-Fi network performance, to ensure its infrastructure could provide an excellent experience for users of the new app, which puts increased demands on the Wi-Fi network. “The London Eye is a global attractio
Watch BizWireTV: A Camera You Can Wear and Krispy Kreme’s Famous Donuts Get Eclipsed with Chocolate17.8.2017 12:08 | Pressemelding
On BizWireTV, catch some Quick Biz Hits and see the latest in Star Power. Also see what’s happening in the startup world with the Accelerator Report, featuring the VC Watch and this week’s Startup Standout. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170817005305/en/ BizWireTV is hosted by Jordyn Rolling (Photo: Business Wire Now you can watch BizWireTV, and the latest breakthroughs in tech from the biggest brands, on any screen you want by downloading the new app through the Apple TV and iPhone App Store and Google Play for Android devices. Top of the Wire Introducing FrontRow: the camera re-invented. Watch BizWireTV to see more disruptors as well as the top 5 trending stories of the week! A core c
PsiOxus Therapeutics Announce Two New Board Appointments: New Board Appointments Strengthen Company’s US Presence17.8.2017 07:00 | Pressemelding
PsiOxus Therapeutics, Ltd. (PsiOxus) today announced the appointment of Charles Rowland and Duncan Higgons to the Board of Directors as part of an ongoing drive to expand in the US. Charles Rowland was most recently the President and Chief Executive Officer (CEO) of Aurinia Pharmaceuticals, a clinical stage pharmaceutical company focused on the global lupus nephritis market. Prior to this, he served as the Vice President and Chief Financial Officer (CFO) of ViroPharma, during which time the company grew into a global biopharmaceutical business with $500 million in annual revenues until it was acquired by Shire plc for $4.2 billion. Before joining ViroPharma, Mr. Rowland was executive Vice President, CFO, and interim co-CEO, for Endo Pharmaceuticals. In his earlier career, Charles held finance and operational positions at Biovail Pharmaceuticals, Breakaway Technologies, Pharmacia
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom