Business Wire

Data Showing Potential for Machine Learning to Advance Understanding of Nonalcoholic Steatohepatitis (NASH) Presented at the Liver Meeting® 2019

Share

Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from the company’s nonalcoholic steatohepatitis (NASH) research and development program, including studies evaluating machine learning approaches to the interpretation of liver histology, noninvasive tests (NITs) for the characterization and monitoring of disease severity, and novel therapies for the treatment of this disease. The data are being presented at The Liver Meeting® 2019 in Boston this week.

“By combining data from across our NASH clinical development program with artificial intelligence (AI)-based tools, we have the opportunity to better characterize this complex disease and understand how potential therapies can impact disease progression,” said Mani Subramanian, MD, Senior Vice President, Liver Diseases, Gilead Sciences. “Applying PathAI’s deep learning research platform for liver histology assessment will enable a more rigorous review of treatment response and has potential for the exploration of novel biology in patients with advanced fibrosis due to NASH.”

Machine Learning in NASH

In a collaboration with PathAI, a leader in AI-powered research in pathology, Gilead is evaluating machine learning approaches to liver histology assessment for use in the diagnosis and staging of NASH and monitoring of treatment response in clinical trials. A study of images from liver biopsies from patients screened for the Phase 3 STELLAR program compared the staging and characterization of liver disease as assessed by experienced pathologists and by the PathAI research platform. The pathologists scored biopsies using the NASH Clinical Research Network (CRN) and Ishak fibrosis classifications, and the PathAI research platform, a convolutional neural network, evaluated these biopsies following training on more than 68,000 annotations from 75 board-certified pathologists.

The results showed that the machine learning models and the consensus of readings from the independent pathologists demonstrated high consistency for the key histologic features of NASH. Importantly, for the staging of fibrosis, the predictions of the machine learning model were highly correlated with those of the central pathologist for both the NASH CRN (rs=0.83) and Ishak (rs=0.86) staging systems.

“The evaluation of new therapies for NASH can be advanced with quantitative and reproducible assessment of liver pathology,” said Andy Beck, MD, PhD, PathAI co-founder and Chief Executive Officer. “We are thrilled to apply the PathAI research platform to support development of new treatment approaches.”

In a separate analysis, machine learning models were developed to recognize patterns associated with each fibrosis stage, using slide-level pathologist Ishak fibrosis stages. Images of liver biopsies from 674 patients with compensated cirrhosis (F4) enrolled in the Phase 3 STELLAR-4 clinical trial demonstrated that machine learning models are predictive of disease progression, illustrate the heterogeneity of fibrosis in NASH cirrhosis, and correlate with noninvasive markers of fibrosis. These data highlight the potential of machine learning models to characterize patients with cirrhosis beyond conventional histological staging.

NITs for Risk Stratification and Monitoring of NASH Patients

Analyses of the Phase 3 STELLAR clinical trials indicate that NITs can play an important role in the risk stratification and monitoring of NASH patients. Results from a poster presentation demonstrated that greater fibrosis burden at baseline, as assessed by NITs (e.g., Enhanced Liver Fibrosis (ELF) test and NAFLD Fibrosis Score (NFS)), and greater increases in these markers over time, are both associated with an increased risk of disease progression. An additional analysis showed that in patients with advanced fibrosis due to NASH, treatment response defined by improvements in ELF or liver stiffness by transient elastography (TE) are associated with consistent improvements in other clinical parameters, including liver biochemistry, liver stiffness, and glycemic indices, whereas only histologic parameters improved in responders defined by liver histology. These data support the potential utility of NITs for the monitoring of NASH patients and as endpoints in clinical trials.

Combination Therapy with Fenofibrate Mitigates Triglyceride Elevations in NASH Patients Treated With Investigational Firsocostat

Gilead is investigating the potential role of acetyl-CoA carboxylase (ACC) inhibitors in the treatment of NASH. In a late-breaker session, Gilead will present results from a study evaluating the safety and efficacy of fenofibrate in mitigating increases in serum triglycerides (TGs) in patients with hypertriglyceridemia and advanced fibrosis due to NASH who were treated with the ACC inhibitor firsocostat. Patients were randomized to receive treatment with fenofibrate 48 mg or 145 mg orally once daily for two weeks, followed by the combination of fenofibrate and firsocostat 20 mg daily for 24 weeks. Results indicate that after 24 weeks of combination treatment, TGs were not significantly different from baseline in the 48 mg group (p=0.09) and 145 mg group (p=0.99). These results indicate that in patients with advanced fibrosis due to NASH, fenofibrate mitigates firsocostat-induced increases in serum triglycerides. The combination of firsocostat and fenofibrate also led to significant improvements in hepatic fat, liver biochemistry and markers of fibrosis. Fenofibrate alone and in combination with firsocostat was well-tolerated; no grade 3 or 4 adverse events, treatment-related discontinuations or hepatotoxicity were observed.

Firsocostat is an investigational compound and is not approved by the U.S. Food & Drug Administration (FDA) or any other regulatory authority. Safety and efficacy have not been established.

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 with advanced fibrosis, defined as bridging fibrosis (F3) or cirrhosis (F4), are at a significantly higher risk of liver-related 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 ACC inhibitor firsocostat, the selective, non-steroidal FXR agonist cilofexor, and the ASK1 inhibitor selonsertib, which are being studied in the Phase 2 ATLAS trial in advanced fibrosis due to NASH.

These investigational compounds 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.

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.

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 and PathAI may not realize the potential benefits of this collaboration. There is also the possibility of unfavorable results from ongoing and additional Gilead clinical programs in NASH, including clinical trials involving firsocostat, and the possibility that Gilead may be unable to complete these clinical studies in the currently anticipated timelines or at all. Further, it is possible that Gilead may make a strategic decision to discontinue development of firsocostat and other investigational compounds for the treatment of NASH 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, 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.

Contact information

Greg Mann, Investors
(424) 322-1795

Arran Attridge, Media
(650) 425-8975

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(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

Michael Buckley to Return to True Religion Apparel as Chief Executive Officer12.11.2019 18:30:00 CETPress release

True Religion Apparel, Inc., announced that the Board of Directors has appointed Michael Buckley as its new Chief Executive Officer, effective immediately. Mr. Buckley was previously President of True Religion Apparel from 2006 to 2010. He will be responsible for developing and implementing the future vision and roadmap for True Religion. Mr. Buckley will report to the Board of Directors of the Company. Michael Buckley is a leading retail and consumer products executive with over 30 years’ successful industry experience both domestically and internationally in growing brands and creating value. He most recently was Chief Executive Officer of Differential Brands Group (renamed Centric Brands upon the acquisition of Global Brands Group) a NASDAQ publicly traded company. Differential owned the brands Hudson Jeans, Robert Graham and Swims. Prior to Differential, from 2011-2016 he was Chief Executive Officer of Robert Graham Designs until its sale to Differential Brands Group for $180 milli

Bempedoic Acid Significantly Reduces LDL-Cholesterol on Top of Statin Therapy: Results of the CLEAR Wisdom Trial, Published in the Journal of the American Medical Association12.11.2019 16:08:00 CETPress release

Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) today announced the publication of results from the Phase 3 CLEAR Wisdom trial in the Journal of the American Medical Association (JAMA).1 Bempedoic acid is currently undergoing review for marketing authorisation by the European Medicines Agency (EMA) and by the United States Food and Drug Administration (FDA). CLEAR Wisdom, a Phase 3, double-blind, randomised trial, evaluated the efficacy, long-term safety and tolerability of bempedoic acid 180 mg versus placebo in 779 patients with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolaemia (HeFH) inadequately controlled with current lipid-modifying therapies, added on to maximally-tolerated statin therapy, which may mean no statin at all.1 The JAMA publication includes results for the primary efficacy endpoint of low-density lipoprotein cholesterol (LDL-C) lowering at 12 weeks and key secondary endpoints of safety and tolerability over 52

 Vertex Confirms Northern Ireland Offer Accepted for Cystic Fibrosis Medicines12.11.2019 15:57:00 CETPress release

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today confirms that the Regional Pharmaceutical Procurement Service in Northern Ireland has accepted an offer for access to all currently licensed Vertex cystic fibrosis (CF) medicines and any future indications of these medicines under the same terms as the recently announced agreement with NHS England. This means that once the contract is finalized, patients with CF in Northern Ireland ages 2 years and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene will have access to ORKAMBI ® (lumacaftor/ivacaftor) and CF patients ages 12 years and older who either have two copies of the F508del mutation or one copy of the F508del mutation and a copy of one of the other 14 licensed mutations will have access to SYMKEVI® (tezacaftor/ivacaftor) in combination with ivacaftor. We will support the arrangements being put in place to ensure clinicians will be able to prescribe to el

Andersen Global Announces First Collaboration in Croatia12.11.2019 14:30:00 CETPress release

Andersen Global announced today that it signed a Collaboration Agreement with one of Croatia’s largest law firms, KALLAY & PARTNERS Ltd. The addition of the Zagreb-based firm establishes Andersen Global’s presence in the country and continues the expansion of the organization in the region. Founded in 2006, KALLAY & PARTNERS Ltd. is led by Founder and Office Managing Director Marko Kallay. Under his leadership, the firm provides both foreign and domestic clients with a broad range of legal services, including banking and finance, commercial and corporate law, dispute settlement, arbitration and mediation, labor law, and regulator relationships. “Our firm values commitment, transparency, reliability and providing clients with the best-in-class legal services, and these values align well with Andersen Global’s standards and vision,” said Marko. “This collaboration will allow us to take our client service to the next level and expand our footprint more broadly. We are excited to work clos

Report: The Delivery Economy Uncovering Misalignment In the Supply Chain12.11.2019 14:00:00 CETPress release

The rapid growth of the Delivery Economy — the pervasive sentiment in which customers expect low-cost, fast and highly transparent delivery of goods — is pressuring companies to quickly address structural supply chain challenges that make it difficult for them to meet increasing customer demands, according to a new report from project44, the global leader in advanced visibility for shippers and logistics service providers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191112005320/en/ (Graphic: Business Wire) The new report from project44, “Aligning the Supply Chain In The Age Of The Delivery Economy,” is based on a blind survey of 300 supply chain professionals. It is the second in a series of reports examining the emergence and impact of the Delivery Economy. The report highlights key issues plaguing both B2B and B2C supply chains and preventing adoption of the organization-wide delivery strategies that will be critical t

Modern Governance 8.0: New Report from Stanford’s Rock Center and Diligent Institute Reveals Corporate Directors Are Less Shareholder-Centric and Success Is No Longer Defined Solely by Shareholder Returns12.11.2019 14:00:00 CETPress release

In a new report released today, Diligent Institute and the Rock Center for Corporate Governance at Stanford University found that board directors consider both shareholder and stakeholder needs when making strategic decisions – reinforcing a stakeholder movement that embraces modern governance. The report, “Stakeholders Take Center Stage: Director Views on Priorities and Society,” includes responses and interviews with nearly 200 directors of public and private corporations globally. According to the survey, a vast majority of corporate directors (89%) believe it is important or very important for their company to consider the interests of non-shareholder stakeholders – such as employees, local communities, and the general public – as they work to achieve business objectives. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191112005426/en/ The findings of this report echo the sentiments of the recent Business Roundtable “Stat