Phase 2 Data for Selonsertib in Nonalcoholic Steatohepatitis (NASH) Presented at The Liver Meeting® 2016
14.11.2016 21:30 | Business Wire
Gilead Sciences (Nasdaq:GILD) today announced detailed results from an open-label Phase 2 trial evaluating the investigational apoptosis signal-regulating kinase 1 (ASK1) inhibitor selonsertib (formerly GS-4997) alone or in combination with the monoclonal antibody simtuzumab (SIM) in patients with nonalcoholic steatohepatitis (NASH) and moderate to severe liver fibrosis (fibrosis stages F2 or F3). The data demonstrate regression in fibrosis that was, in parallel, associated with reductions in other measures of liver injury in patients treated with selonsertib for 24 weeks. These data were presented in a late-breaking abstract session at The Liver Meeting® 2016 in Boston (#LB-3).
Patients receiving selonsertib demonstrated improvements in several measures of liver disease severity, including fibrosis stage, progression to cirrhosis, liver stiffness (measured by magnetic resonance elastography, MRE) and liver fat content (measured by magnetic resonance imaging (MRI)-proton density fat fraction, PDFF). Data for these efficacy endpoints are summarized in the table below. As no differences were observed between combination and monotherapy, results are presented for selonsertib (18 mg and 6 mg) with/without SIM and for SIM alone. Additionally, patients with fibrosis improvement demonstrated reductions in hepatic collagen content, liver biochemistry (e.g., serum ALT) and the apoptosis marker, cytokeratin-18, supporting the biological activity of selonsertib.
|Endpoint (Week 24)||
18 mg ± SIM
|Fibrosis Improvement ≥1 Stage from Baseline*||43% (n=13/30)||30% (n=8/27)||20% (n=2/10)|
|Progression to Cirrhosis||3% (n=1/30)||7% (n=2/27)||20% (n=2/10)|
|≥15% Reduction in Liver Stiffness by MRE||20% (n=5/25)||32% (n=7/22)||0% (n=0/7)|
|≥30% Reduction in Liver Fat by MRI-PDFF||26% (n=8/31)||13% (n=3/24)||10% (n=1/10)|
*Fibrosis staged according to the NASH Clinical Research Network (CRN) classification by a central pathologist blinded to treatment group.
Selonsertib demonstrated no dose-related increases in treatment-emergent adverse events or serious adverse events. Headache, nausea and sinusitis were the most common adverse events in patients receiving selonsertib.
“Currently, no approved treatments exists for NASH, and patients with advanced fibrosis would potentially benefit from new options to halt and/or reverse the progression of their disease,” said Rohit Loomba, MD, MHSc, lead study author and Director, NAFLD Research Center, Director of Hepatology, Professor of Medicine, Vice Chief, Division of Gastroenterology, University of California San Diego School of Medicine. “After only 24 weeks of therapy, selonsertib exhibited promising anti-fibrotic activity in this study, which was the first known multi-center NASH clinical trial to use centrally-assessed MRE, MRI-PDFF, in addition to liver biopsy as endpoints. Based on these data, selonsertib represents an important investigational drug candidate for further clinical trials in patients with NASH and significant fibrosis.”
Other Gilead NASH data being presented at The Liver Meeting include results from Phase 1 studies evaluating the investigational selective, non-steroidal Farnesoid X receptor (FXR) agonist GS-9674. Data from a Phase 1 study demonstrated the biological activity and safety profile of GS-9674 in healthy volunteers and support the evaluation of this compound in patients with NASH and cholestatic liver disorders (#1077 and #1140). Phase 2 studies with GS-9674 are ongoing in patients with NASH, primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC).
Additionally, preclinical data for the combination of selonsertib and GS-9674 in a rodent model of advanced fibrosis suggested that the combination of selonsertib and GS-9674 resulted in greater anti-fibrotic activity than either agent alone (#1588). These preclinical data support clinical evaluation of combination approaches with selonsertib and GS-9674 in patients with NASH and advanced fibrosis.
Selonsertib, GS-9674 and simtuzumab have not been determined to be safe or efficacious.
About Selonsertib and the 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.
This Phase 2, randomized, open-label trial evaluated the safety, tolerability and efficacy of selonsertib alone or in combination with SIM in 72 patients with NASH and fibrosis stages F2 (n=25) or F3 (n=47). Eligible patients were randomized (2:2:1:1:1) to receive selonsertib 6 mg (n=20), selonsertib 18 mg (n=22), selonsertib 6 mg plus SIM 125 mg (n=10), selonsertib 18 mg plus SIM 125 mg (n=10) or SIM 125 mg alone (n=10) for 24 weeks. Selonsertib was administered orally once daily and SIM was administered via weekly subcutaneous injection.
About Gilead’s Clinical Programs in NASH
Gilead is advancing a pipeline of novel investigational therapies for the treatment of NASH with advanced fibrosis. Gilead is currently planning or conducting Phase 2 and Phase 3 clinical trials evaluating single-agent and combination therapy approaches against multiple core pathways associated with NASH – metabolic dysfunction, inflammation and fibrosis. Compounds in development include the ASK1 inhibitor, selonsertib; the FXR agonist, GS-9674; and an inhibitor of acetyl-coA carboxylase (ACC), GS-0976, currently being evaluated in a Phase 2 study in patients with NASH.
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 Gilead’s ability to initiate or complete its Phase 2 and Phase 3 clinical trial programs evaluating selonsertib, GS-9674 and GS-0976 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, GS-9674 and GS-0976 if, for example, Gilead believes commercialization will be difficult relative to other opportunities in its pipeline. As a result, selonsertib, GS-9674 and GS-0976 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, 2016, 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, 650-524-7792
Nathan Kaiser, 650-522-1853
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
Permasteelisa Group to Join Grandland21.8.2017 04:11 | Pressemelding
Worldwide leading contractor in engineering, project management, manufacturing and installation of architectural envelopes and interior systems, Permasteelisa Group, will join forces with Grandland Group – a fast growing, Shenzhen-based specialist in design and construction of architectural decoration. The strategic alliance will create the biggest, most comprehensive curtain wall player in the world, with exceptional potential for further growth for both companies. Permasteelisa will remain fully committed to build avant-garde architectures and top end, high-quality projects which have become its trademark. The news comes today after LIXIL Group Corporation (LIXIL Group) (TOKYO: 5938) – a global leader in the housing and building industry – announced that it has decided to sell 100% of shares of Permasteelisa S.p.A., held by its major subsidiary LIXIL Corporation, to Grandland Holding
LIXIL to Sell Permasteelisa to Grandland21.8.2017 03:42 | Pressemelding
LIXIL Group Corporation (LIXIL Group) (TOKYO:5938), a global leader in the housing and building industry, today announced that it has decided to sell 100% of the shares of Permasteelisa S.p.A (Permasteelisa) held by its major subsidiary LIXIL Corporation to Grandland Holdings Group Limited (Grandland), a leading Chinese architectural design and construction company. The transaction is subject to customary closing conditions and regulatory approvals, including in China, the United States and Russia. Under the terms of the agreement, the base sale price for Permasteelisa is EURO 467 million. As a result of this transaction and the deconsolidation of Permasteelisa from LIXIL Group, LIXIL Group’s revenue for the full fiscal year ending March 2018 is expected to decrease by approximately 170.0 billion yen from the amount announced on May 8, 2017 (by approximately 9.2% of the previously fore
Samsung Bioepis and Takeda Sign Strategic Collaboration Agreement to Co-Develop Multiple Novel Biologic Therapies20.8.2017 23:30 | Pressemelding
Samsung Bioepis Co., Ltd. announced today that it has entered into a strategic collaboration agreement with Takeda Pharmaceutical Company Limited (TSE: 4502) to jointly fund and co-develop multiple novel biologic therapies in unmet disease areas. The two companies will immediately begin working on the program’s first therapeutic candidate, TAK-671, which is intended to treat severe acute pancreatitis. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170820005028/en/ Christopher Hansung Ko, President & CEO of Samsung Bioepis. (Photo: Business Wire) “Takeda’s extensive knowledge and expertise in drug development makes the company an ideal partner for us as we open a new chapter at Samsung Bioepis,” said Christopher Hansung Ko, President and CEO, Samsung Bioepis. “Five years ago, we entered
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
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom