Business Wire

Gilead Presents New Data in Nonalcoholic Steatohepatitis (NASH) at the International Liver Congress™ 2019

Jaa

Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from the company’s clinical research program in nonalcoholic steatohepatitis (NASH) being presented at The International Liver Congress™ 2019 in Vienna. The data support Gilead’s efforts to develop combination therapies to target different aspects of NASH, evaluate the utility of noninvasive tests for the identification of patients living with the disease and advance overall understanding of the complexities and burden of NASH.

“NASH is a complex disease with multiple biological pathways that influence its progression. Combination therapeutic approaches which target these pathways, are likely to be needed to effectively treat patients living with NASH, particularly those with advanced fibrosis who have the greatest unmet need,” said John McHutchison, AO, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. “We are encouraged by the results of our proof-of-concept study being presented this week and look forward to sharing further combination data from the Phase 2 ATLAS trial later this year.”

Combination Therapy Treatment for NASH

A proof-of-concept study demonstrated that the combination of the investigational, selective, non-steroidal farnesoid X receptor (FXR) agonist cilofexor (GS-9674) and the acetyl-CoA carboxylase (ACC) inhibitor firsocostat (GS-0976) resulted in improvements in hepatic steatosis, liver stiffness, liver biochemistry and serum fibrosis markers. In the study, 20 patients with NASH received cilofexor 30 mg and firsocostat 20 mg orally once daily for 12 weeks. A significant decline of at least 30 percent in hepatic fat measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) from baseline to 12 weeks was observed in 74 percent of patients. Improvements in liver biochemistry tests including serum ALT (median relative reduction, -37%; p<0.001) and GGT (-32%; p<0.001), along with markers of reduced bile acid synthesis, were observed at 12 weeks. Treatment was well tolerated and pruritus was not reported in any patients. Asymptomatic, Grade 3 hypertriglyceridemia was observed in two patients. No patients withdrew from the study due to adverse events.

Noninvasive Tests

Liver biopsy is currently the reference standard to identify patients with NASH but is an invasive and costly procedure with potential for serious complications. Gilead will present an analysis of screening data from its Phase 2 ATLAS study evaluating combinations of investigational cilofexor, firsocostat and selonsertib in advanced fibrosis due to NASH.

This analysis demonstrates that the use of currently available noninvasive tests (NITs) can accurately identify patients with advanced fibrosis due to NASH and potentially reduce the need for liver biopsy. When used in combination, the Enhanced Liver Fibrosis (ELF) test and FibroScan® accurately identified advanced fibrosis in >80 percent of patients.

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.

Burden of Disease and Patient-Reported Outcomes

While NASH can have non-specific symptoms, research is needed to understand the impact of disease on quality of life for those living with the condition, measured through patient-reported outcomes (PROs). Baseline data from the STELLAR Phase 3 trials showed significant burden of disease among people with advanced fibrosis due to NASH. In 1,667 patients enrolled in the STELLAR trials, PROs assessed using tools including the Chronic Liver Disease Questionnaire (CLDQ-NASH) prior to treatment, particularly those related to physical health-related scores, were significantly lower than those of population norms. In another analysis of patients enrolled in the STELLAR program, diabetes mellitus was associated with impairment in PROs including physical functioning, bodily pain, general health and vitality. An additional study assessing health-related quality of life in 1,338 patients with advanced fibrosis due to NASH demonstrated that these individuals have more impairment of their physical health-related scores than patients with chronic hepatitis C virus.

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 living with fibrosis 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 trial evaluating combinations of selonsertib, cilofexor and firsocostat in advanced fibrosis (F3 and F4) due to NASH.

Selonsertib is an investigational compound and is not approved by the U.S. Food & Drug Administration (FDA) or any other regulatory authority.

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 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 Annual Report on Form 10-K for the year ended December 31, 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.

Contact information

Sung Lee, Investors
(650) 524-7792

Arran Attridge, Media
(650) 425-8975

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Age Matters: PMI Calls All Tobacco and E-Cigarette Companies To Do Their Part to Guard Against Youth Nicotine Use23.4.2019 20:29:00 EESTTiedote

Philip Morris International Inc. (PMI) (NYSE: PM) today reaffirmed its vision for the future: To achieve a smoke-free world; that is, one without cigarettes. For the hundreds of millions of men and women globally who will otherwise continue to smoke, PMI’s goal is to switch them to nicotine-containing products that are scientifically substantiated as better choices than continuing to smoke. Our strong belief—if you don’t smoke, don’t start—begins with a continued and robust focus on preventing youth from beginning to smoke or use nicotine products. “Given the rapid pace of innovation in the tobacco products space, we are emphatic that youth should not use any tobacco- or nicotine-containing product. Nicotine is addictive. It is not risk-free, and it poses particular risks for adolescents. We know that great care must be taken to achieve our smoke-free goal. Youth should not become nicotine users. Former smokers and never smokers should not return to, or pick up, the tobacco or nicotine

Personalis, Inc. to Present at European NeoAG Summit 201923.4.2019 18:00:00 EESTTiedote

Personalis, Inc., a leader in advanced genomics for cancer, today announced that the company will present at European NeoAG Summit 2019 in Amsterdam on April 24th at 2:30 PM CEST. The presentation, entitled “ImmunoID NeXT Platform: Improving Neoantigen Prediction, TME Assessment, and ctDNA Detection for Vaccine Development,” will introduce Personalis’ new universal cancer immunogenomics platform, ImmunoID NeXT™. In addition to an overview, the presentation will highlight innovative genomics methods for more comprehensive assessment of neoantigens, which include improving neoantigen-to-MHC binding prediction and ranking and assessing TME/TCR and tumor escape mechanisms that may impact vaccine response. ImmunoID NeXT is the first platform to provide comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays i

Keio Plaza Hotel Tama Opens My Melody, Little Twin Stars Rooms on June 15, 2019 - Sweet Dreams in Our Hello Kitty and Sanrio Character Rooms23.4.2019 17:05:00 EESTTiedote

The Keio Plaza Hotel Co., Ltd., one of Japan’s most prestigious hotel companies operating hotels located in the Shinjuku district of Tokyo and other locations, is proud to announce the strengthening of its collaborative relationship with Sanrio Co., Ltd. (Headquarters: Shinagawa, Tokyo, President and CEO: Shintaro Tsuji) to expand facilities and services featuring “Hello Kitty” and other Sanrio characters at our Keio Plaza Hotel Tama. Our Tama Hotel will renovate a total of four additional rooms, including two rooms each in the themes of “My Melody” and “Little Twin Stars” (Kiki and Lala) who have been adored by fans around the world since their creation in 1975, to be opened on Saturday June 15, 2019, and thereby become the world’s first hotel to operate rooms in these themes on a regular basis. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190423005311/en/ New Sanrio characters rooms, including two rooms each in the theme

Project Management Institute, Inc. (PMI) Delivers Full Suite of Certification Exams in Over 5,000 Locations Through Expanded Testing Agreement with Pearson VUE23.4.2019 17:00:00 EESTTiedote

Project Management Institute, Inc. (PMI), the leading not-for-profit professional membership association for the project management profession, and Pearson VUE, a global leader in the computer-based testing industry, have announced an expanded, multi-year agreement that will offer more testing options for candidates looking to earn PMI certifications at all stages of their career. The new agreement will offer candidates access to even more PMI certification tests as well as more flexibility in their testing location options, thanks to Pearson VUE’s global network of testing centers and online proctoring solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190423005149/en/ Beginning July 1, 2019, seven additional PMI programs, including the Project Management Professional (PMP)® – renowned as the global gold standard for project management professionals – will become available to professionals around the globe through Pe

Andersen Global Marks Growth to 50 Countries with Collaborating Firm in Zambia23.4.2019 16:30:00 EESTTiedote

Andersen Global announced it achieved a new milestone today in its continuing growth with the addition of Mulenga Mundashi Kasonde Legal Practitioners (MMKLP). MMKLP, a law firm in Zambia, has signed a Collaboration Agreement with Andersen Global. The international association now has presence in 50 countries through its member and collaborating firms. Led by five partners, MMK has been advising clients in corporate mergers and acquisitions, tax, litigation, and labor and industrial resolutions since 1999. The firm is now one of the largest law firms in Zambia in its twentieth year. The collaborating firm will be the eleventh location in Africa for Andersen Global. “We’ve had the opportunity to advise on some of the highest profile financial events for Zambia in modern history,” said Micheal Mundashi, MMKLP Managing Partner. “One of the things that keeps us moving forward is the desire to provide even more for our local and international clients. Collaborating with Andersen Global will

Aventri Introduces Uber Vouchers to Deliver New Transportation Options23.4.2019 16:00:00 EESTTiedote

Event management software (EMS) leader Aventri today announces a new partnership with Uber for Business. Aventri is the first EMS provider to launch a partnership with Uber for Business to offer customers the opportunity to utilize Uber Vouchers. Uber Vouchers’ web-based tool allows event organizers to provide VIP treatment to attendees with stress-free, reliable transportation to and from events. “We’re always looking for new partners to help our customers streamline events and add value,” said Brad Langley, vice president of channel and partner management for Aventri. “Uber for Business fits the bill. Using Uber Vouchers, organizers spend less time arranging logistics for moving groups, and their guests can come and go at a time that’s convenient for them.” Using Uber Vouchers, organizers can enhance the journey for themselves and their guests. Some benefits include: Customized Control: Organizers can easily create and manage campaigns online by setting parameters for pickup, drop-of

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme