Gilead Announces Topline Data From Phase 3 STELLAR-4 Study of Selonsertib in Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that STELLAR-4, a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib, an investigational, once-daily, oral inhibitor of apoptosis signal-regulating kinase 1 (ASK1), in patients with compensated cirrhosis (F4) due to nonalcoholic steatohepatitis (NASH), did not meet the pre-specified week 48 primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of NASH.
In the study of 877 enrolled patients who received study drug, 14.4 percent of patients treated with selonsertib 18 mg (p=0.56 vs. placebo) and 12.5 percent of patients treated with selonsertib 6 mg (p=1.00) achieved a ≥ 1-stage improvement in fibrosis according to the NASH Clinical Research Network (CRN) classification without worsening of NASH after 48 weeks of treatment, compared with 12.8 percent of patients who received placebo. Selonsertib was generally well-tolerated and safety results were consistent with prior studies.
“While we are disappointed that the STELLAR-4 study did not achieve its primary endpoint, we remain committed to advancing therapies for patients with advanced fibrosis due to NASH, where there is a significant unmet need for effective and well-tolerated treatments. Gilead has a long-term commitment and proven track record of addressing significant challenges in the field of liver diseases. Data from this large study of patients with compensated cirrhosis due to NASH, including the extensive set of biomarkers collected, will further advance our understanding of the disease and inform our broader NASH development programs,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead. “We are grateful to the patients and investigators who participated in the STELLAR-4 study, and we now await the upcoming results from the Phase 3 STELLAR-3 trial of selonsertib in patients with bridging fibrosis (F3) due to NASH and the Phase 2 ATLAS combination trial of selonsertib, cilofexor (GS-9674) and firsocostat (GS-0976) in patients with advanced fibrosis due to NASH later this year.”
Further in-depth analysis of the findings is ongoing and the data will be submitted to an upcoming scientific conference. Gilead will work with the Data Monitoring Committee and investigators to conclude the STELLAR-4 study in a manner consistent with the best interests of each patient.
Selonsertib, cilofexor and firsocostat, alone or in combination, are investigational compounds and 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 Selonsertib and the STELLAR-4 Study
Selonsertib is an investigational small molecule inhibitor of ASK1, a protein that promotes inflammation, apoptosis (cell death) and fibrosis in settings of oxidative stress. Oxidative stress can be increased in many pathological conditions including liver diseases such as NASH.
The STELLAR-4 study is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of selonsertib in patients with compensated cirrhosis (F4) due to NASH. Eligible adults ages 18 to 70 years were randomized and received selonsertib 18 mg (n=354), selonsertib 6 mg (n=351) or placebo (n=172) for up to 240 weeks. Either selonsertib or placebo is being administered orally once daily. The primary endpoints of the study are a composite of the proportion of patients who achieve a ≥ 1-stage improvement in fibrosis according to the NASH CRN classification without worsening of NASH at week 48 and event-free survival at week 240 as assessed by time to the first clinical event. Further information about the clinical study can be found at www.clinicaltrials.gov.
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, including bridging fibrosis (F3) or compensated cirrhosis (F4), are at a significantly higher risk of liver-related mortality 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 ASK1 inhibitor selonsertib, the selective, non-steroidal FXR agonist cilofexor (GS-9674) and the ACC inhibitor firsocostat (GS-0976). The STELLAR-3 Phase 3 trial evaluating selonsertib among NASH patients with bridging fibrosis (F3) is ongoing. Cilofexor and firsocostat are currently in Phase 2 studies in NASH, including the ATLAS Phase 2 trial evaluating combinations of selonsertib, cilofexor and firsocostat in advanced fibrosis (F3 and F4) due to NASH.
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 Gilead’s ability to complete its clinical trial programs evaluating single-agent and combination therapy approaches, including selonsertib, cilofexor and/or firsocostat, 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 selonsertib, cilofexor and/or firsocostat 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, 2018, 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.
Sung Lee, 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
Mori Building Unveils Massive Urban Regeneration Project in Central Tokyo22.8.2019 07:00:00 EEST | Press release
Mori Building Co., Ltd., a leading urban landscape developer, has begun construction on its “Toranomon-Azabudai District Category 1 Urban Redevelopment Project,” a massive urban regeneration project aimed at revitalizing a large area of central Tokyo. A groundbreaking ceremony was held on August 5 and project completion is scheduled for the end of March 2023. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190821005445/en/ Image of Office Lobby (Graphic: Business Wire) The core concept of the Toranomon-Azabudai Project is that of a “Modern Urban Village,” a unique neighborhood that will combine the sophistication of a megalopolis with the intimacy of a small village in the heart of Tokyo. It will cover an area of approximately 8.1 hectares, similar to that of New York’s Rockefeller Center, and will feature extensive greenery totaling 24,000 m2 including a 6,000 m2 central square. Total floor area will be 860,400 m2, including
Mundipharma Announces the Licence Extension Submission for Invokana® (canagliflozin) and Vokanamet® (canagliflozin and metformin) to the European Medicines Agency22.8.2019 02:01:00 EEST | Press release
STRICTLY FOR EUROPEAN MEDICAL AND PHARMACEUTICAL TRADE MEDIA ONLY As the European distributor of Invokana® (canagliflozin) and Vokanamet® (canagliflozin and metformin), Mundipharma welcomes the news that the European Medicines Agency (EMA) has accepted the licence extension submission for these two medicines to treat stage 2 or stage 3 chronic kidney disease (CKD) and albuminuria as an adjunct to standard of care in adults with type 2 diabetes mellitus (T2DM). The submission is based on the results from the landmark Phase III CREDENCE study1 which evaluated the efficacy and safety of canagliflozin versus placebo in this high-risk patient population when used in addition to standard of care. “Chronic kidney disease is a serious complication of type 2 diabetes, which can increase patients’ risk of developing end-stage renal disease and may reduce their life expectancy by several years.” said Dr Vinicius Gomes de Lima, European Medical Affairs Lead, Mundipharma. “If approved, this licence
Triton Digital Releases Webcast Metrics Rankings for the Top Digital Audio Properties for April 201921.8.2019 23:00:00 EEST | Press release
Triton Digital®, the global technology and services leader to the digital audio and podcast industry, released today its monthly Webcast Metrics® rankers for April 2019. The global rankers, in addition to the U.S., LATAM, and EMEA regional rankers provide insight into the top-performing streaming audio stations and networks around the world for the month of April. The full results of the Global & Regional Rankers for April 2019 can be found here: https://www.tritondigital.com/resources/monthly-rankers/rankers-archive The Webcast Metrics streaming measurement service is the industry standard for online audio consumption data. It provides credible, validated data that enables audio publishers around the world to analyze the consumption of their audio content by daypart, device type, geography, distribution platform, and more. About Triton Digital Triton Digital® is the global technology and services leader to the digital audio and podcast industry. Operating in more than 40 countries, Tr
Celsius Partners With Tether to Bring USDT its Highest Interest-earning Wallet at 10.53% APR21.8.2019 18:15:00 EEST | Press release
Celsius Network (https://celsius.network/), the industry-leading cryptocurrency platform, announces today its partnership with Tether, a stablecoin which pegs its value to the US dollar. The Celsius app now supports the USDT ERC20 stablecoin allowing USDT holders to earn rewards and request loans on a far less volatile asset than other cryptocurrencies. Celsius users can now request a loan issued in USDT, in addition to the existing stablecoins and fiat loan options available through Celsius, at rates as low as 4.95% APR. The company currently offers interest income of 8.1% APR on USDT deposits and 10.53% when paid in CEL tokens. At the same time, using stablecoins reduces capital costs, allowing Celsius to offer loans at a lower rate. Celsius has achieved notable milestones in the past year to drive the decentralization of traditional financial structures: Over $2.2 billion worth of coin loans originated since July 2018 Over $350 million AUM in customer deposits and collateral from lo
The World's First 5nm Generation AI Chip is Taped Out - TeraPixel Technologies, Inc.21.8.2019 17:00:00 EEST | Press release
TeraPixel Technologies Inc. (Representative: Naoki Kawahara) taped out “Extrixa Processor” as the first deep-learning AI product on March 8, 2019 as the world's first chip that uses TSMC 5nm. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190821005023/en/ Picture of Mechanical Sample for 5nm Deep Learning AI Processor (Photo: Business Wire) Wafer equipped with ASIC implemented in the world's most advanced process rolls out on August 25 and is scheduled to be available in early September after assembly testing. This 5nm process will be used to check the core performance and power consumption since SRAM cells were not yet prepared at the time of tape-out in March. In the first quarter of 2020, we will tape out the second version with the same functions as the product version with SRAM and other functional blocks. TeraPixel has R & D technology for massively parallel processors with many cores, aiming for the world's highest le
Cummins President and COO Rich Freeland Retiring21.8.2019 16:00:00 EEST | Press release
Cummins Inc. (NYSE: CMI) announced today that President and COO, Rich Freeland will retire after forty years of service with Cummins. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190821005396/en/ Rich Freeland (Photo: Business Wire) As part of Cummins’ successions plans, the following leadership appointments are also taking place, all of which are effective October 15. Distribution President Tony Satterthwaite will succeed Freeland as President and COO. Components President Tracy Embree will succeed Satterthwaite as Distribution Business President. Chief Technical Officer Jennifer Rumsey will succeed Embree as Components Business President. Jim Fier will succeed Rumsey as Chief Technical Officer. “I want to personally thank Rich for his many contributions to Cummins and his friendship and support over the 25 years I have known and worked with him,” said Tom Linebarger, Chairman and CEO, Cummins Inc. “He is one of the most
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