Data Showing Potential for Machine Learning to Advance Understanding of Nonalcoholic Steatohepatitis (NASH) Presented at the Liver Meeting® 2019
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.
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.
Greg Mann, Investors
Arran Attridge, Media
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
GPD Companies, Inc. to Acquire Distrupol22.1.2021 16:33:00 EET | Press release
GPD Companies, Inc., an affiliate of One Rock Capital Partners, LLC (“One Rock”), today announced that it has entered into a definitive agreement to acquire Distrupol, a subsidiary of Univar Solutions Inc. (NYSE: UNVR) and a leading European distributor of thermoplastics to the polymer processing industry. Terms of the transaction, which is expected to close in the first half of 2021, were not disclosed. Headquartered in Surrey, England, with broad geographic reach across Europe, Distrupol has provided value-added sales and application development of thermoplastic resins for over 50 years. Through its decades-long relationships with world class supply partners, the company offers a robust array of superior performance products and solutions that meet the needs of diverse end users from leading and emerging industries, such as the consumer, medical, automotive, and electrical sectors, among others. Distrupol caters to over 1,300 customers across 13 countries with a portfolio of over 4,0
Schlumberger Announces Fourth-Quarter and Full-Year 2020 Results22.1.2021 14:50:00 EET | Press release
Schlumberger Limited (NYSE: SLB) today reported results for the fourth-quarter and full-year 2020. Fourth-Quarter Results (Stated in millions, except per share amounts) Three Months Ended Change Dec. 31, 2020 Sept. 30, 2020 Dec. 31, 2019 Sequential Year-on-year Revenue $5,532 $5,258 $8,228 5% -33% Income (loss) before taxes - GAAP basis $471 $(54) $452 n/m 4% Net income (loss) - GAAP basis $374 $(82) $333 n/m 12% Diluted EPS (loss per share) - GAAP basis $0.27 $(0.06) $0.24 n/m 12% Adjusted EBITDA* $1,112 $1,018 $1,648 9% -33% Adjusted EBITDA margin* 20.1% 19.4% 20.0% 73 bps 6 bps Pretax segment operating income* $654 $575 $1,006 14% -35% Pretax segment operating margin* 11.8% 10.9% 12.2% 90 bps -40 bps Net income, excluding charges & credits* $309 $228 $545 35% -43% Diluted EPS, excluding charges & credits* $0.22 $0.16 $0.39 37% -44% Revenue by Geography International $4,343 $4,210 $5,834 3% -26% North America 1,167 1,034 2,339 13% -50% Other 22 14 55 n/m n/m $5,532 $5,258 $8,228 5% -
JEOL: Release of a New Cold Field Emission Cryo-Electron Microscope CRYO ARM™ 300 II (JEM-3300)22.1.2021 09:00:00 EET | Press release
JEOL Ltd. (TOKYO:6951) (President & COO Izumi Oi) announces the release of a new cold field emission cryo-electron microscope (cryo-EM), the CRYO ARM™ 300 II (JEM-3300), to be released in January 2021. This new cryo-EM has been developed based on the concept of "Quick and easy to operate and get high-contrast and high-resolution images". This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210121005316/en/ Cold Field Emission Cryo-Electron Microscope CRYO ARM(TM) 300 II (JEM-3300) (Photo: Business Wire) Development Background Recent dramatic improvement of resolution in single particle analysis (SPA) using cryo-EM has led to SPA as an essential method for structural analysis of proteins. To address this market, JEOL released the CRYO ARM™ 300 in 2017. Equipped with a cold field emission gun (Cold FEG) for enhanced resolution and a cryo-stage for loading multiple samples, the CRYO ARM™ 300 has continued to achieve best-in-class res
ViiV Healthcare announces FDA approval of Cabenuva (cabotegravir, rilpivirine), the first and only complete long-acting regimen for HIV treatment22.1.2021 01:12:00 EET | Press release
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved Cabenuva, the first and only complete long-acting regimen for the treatment of HIV-1 infection in adults. Cabenuva is provided as a co-pack with two injectable medicines — ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine — dosed once monthly, as an option to replace the current antiretroviral (ARV) regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]) on a stable regimen, with no history of treatment failure, and with no known or suspected resistance to either cabotegravir or rilpivirine. Prior to initiating treatment of Cabenuva, oral dosing of cabotegravir and rilpivirine should be administered for approximately one month to assess the tolerability of each therapy.1 Lynn Baxter, Head of North America, ViiV H
Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)22.1.2021 00:30:00 EET | Press release
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The BLA submission is based on data from the Phase 2 POD1UM-202 trial evaluating retifanlimab in previously treated patients with locally advanced or metastatic SCAC who have progressed on, or are intolerant of, standard platinum-based chemotherapy. The trial enrolled 94 patients, including several with well-controlled human immunodeficiency virus (HIV) infection. The study, which was recently presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020, resulted in an objective response rate (ORR) of 14% for retifanlimab monotherapy as determined by inde
Wistron and Kalray Announce FURIO1200™ Storage Appliance21.1.2021 19:45:00 EET | Press release
Wistron, a leader in ICT (Information and communications technology) products, and Kalray (Paris:ALKAL) (Euronext Growth Paris: ALKAL), a leading provider in new generation of processors specialized in Intelligent Data Processing from Cloud to Edge, announce the availability of FURIO1200™, a 24-Flash-Drive NVMe-oF based storage node appliance, integrating Kalray’s NVMe-oF K200™ smart storage adapter, powered by its MPPA® Coolidge™ intelligent processor, and Wistron LYMMA chassis. FURIO1200™ is a new type of hyper-fast disaggregated storage solution delivering ultra-high throughput and reliability. It is the ideal solution for Cloud Service Providers and Enterprises running applications with intensive AI and Data Analytics workloads as well as to optimize their next generation storage. Data Centers are undergoing a very important revolution due to the explosion of usages, the surge of data to be processed and the exponential growth of the number of machines to be managed to support this
NumAlim Selects Dawex and Orange Business Services for its Data and Services Exchange Platform21.1.2021 19:40:00 EET | Press release
NumAlim announced an agreement with Dawex, the leader in Data Exchange technology, and Orange Business Services, a network-native digital services company, to deploy its agri-food digital exchange platform. By relying on these two leading players, NumAlim chose secure technological solutions guaranteeing the sovereignty of French food data. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210121005722/en/ (Photo: Dawex) As early as Q1 2021, the NumAlim data and services exchange "Hub" will offer 18,000 companies in the food industry the opportunity to valorize, acquire and enrich all types of data: production, consumption, traceability, consumer opinions and research, as well as a wide range of services based on data (trend analysis, reformulation, regulatory watch…). "NumAlim is the answer to the needs for transparency, value creation and trust expressed by the food industry, consumers, and public authorities.” says Jérôme Fr
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom