Gilead and Galapagos Announce Results With Filgotinib in the Phase 2 Equator Study in Psoriatic Arthritis and Progression Into Phase 3 for the Selection Study in Ulcerative Colitis
Gilead Sciences, Inc. (NASDAQ: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) announced that the randomized, placebo-controlled Phase 2 EQUATOR study of filgotinib, an investigational, selective JAK1 inhibitor, in 131 adults with moderate to severe psoriatic arthritis, achieved its primary endpoint of improvement in the signs and symptoms of psoriatic arthritis at Week 16, as assessed by the American College of Rheumatology 20 percent improvement score (ACR20). There was an ACR20 response of 80 percent for filgotinib versus 33 percent for placebo (p<0.001). The ACR50 and ACR70 responses at Week 16 were also significantly higher for filgotinib versus placebo (ACR50: 48 percent for filgotinib versus 15 percent, p<0.001; ACR70: 23 percent versus 6 percent, p<0.01).
Filgotinib was generally well-tolerated in the EQUATOR trial, with no new safety signals observed and similar laboratory changes compared to those reported in previous trials with filgotinib in rheumatoid arthritis patients. The adverse event rate was similar in both groups with mostly mild or moderate events reported. There was one serious infection in the filgotinib group, a patient who experienced pneumonia with a fatal outcome. One other patient receiving filgotinib developed herpes zoster. There were no cases of opportunistic infection, tuberculosis, thromboembolism, or malignancy.
“The data from the EQUATOR study are very impressive and indicate that filgotinib has the potential to have a significant effect on signs and symptoms of psoriatic arthritis, a condition where there is still a high unmet medical need,” said Dr. Philip Mease, Director of Rheumatology Research, Swedish-Providence-St. Joseph Health Systems and Clinical Professor, University of Washington, Seattle, WA.
“We are pleased to report that filgotinib remains consistent in terms of activity and tolerability, now also in psoriatic arthritis,” said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos.
Detailed results from the EQUATOR trial will be submitted for presentation at a future scientific conference.
Separately, Gilead and Galapagos also announced that an independent Data Monitoring Committee (DMC) conducted a planned interim futility analysis of the filgotinib Phase 2b/3 ulcerative colitis study, SELECTION, after 350 patients completed the induction period in the Phase 2b portion of the study. The DMC recommended that the study proceed into Phase 3 as planned at both the 100 mg and 200 mg once daily dose level in biologic-experienced and biologic-naïve patients.
Galapagos is to receive a $15 million payment from Gilead for this progression from Phase 2 to Phase 3 in the SELECTION trial.
“We continue to see great potential with filgotinib to treat a range of inflammatory diseases,” said John McHutchison, MD, Chief Scientific Officer, Head of Research and Development, Gilead. “As such, we are pleased with the continued progress of the development programs, including the EQUATOR results and advancing the SELECTION study into Phase 3.”
Filgotinib is investigational and its efficacy and safety have not been established. For information about the clinical trials with filgotinib: www.clinicaltrials.gov.
About the EQUATOR Trial
Initiated by Galapagos in April 2017, the EQUATOR Phase 2 trial was a multi-center, randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of the selective JAK1 inhibitor filgotinib in adult patients with moderately to severely active psoriatic arthritis. EQUATOR was conducted in Ukraine, Poland, Estonia, Bulgaria, Spain, Czech Republic, and Belgium. In total 131 patients were randomized in a 1:1 ratio to receive filgotinib 200 mg or placebo once-daily administered for 16 weeks; 85 percent of the patients were naïve to TNF treatment.
The primary objective of EQUATOR was to evaluate the effect of filgotinib compared to placebo on the signs and symptoms of psoriatic arthritis, as assessed by ACR20 at Week 16. Secondary objectives included ACR50/70 and minimum disease activity (MDA) as well as the effects of filgotinib on psoriasis, dactylitis (whole finger inflammation) and enthesitis (inflammation of the tendons).
About Psoriatic Arthritis
Psoriatic arthritis is an inflammatory form of arthritis, affecting up to 30 percent of psoriasis patients. Psoriatic arthritis can cause swelling, stiffness and pain in and around the joints, cause nail changes and overall fatigue. Studies show that delaying treatment for psoriatic arthritis as little as six months can result in permanent joint damage. Early recognition, diagnosis and treatment of psoriatic arthritis are critical to relieve pain and inflammation and help prevent joint damage. Despite the availability of a number of treatment options, few current treatments effectively relieve enthesitis and symptoms in the joints and the skin.
About the SELECTION Phase 3 Trial
Initiated by Gilead in late 2016, the SELECTION Phase 2b/3 trial is a multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of the selective JAK1 inhibitor filgotinib in adult patients with moderately to severely active ulcerative colitis. A total of 1,300 patients are targeted to be randomized to receive filgotinib 100 mg, 200 mg, or placebo once-daily administered for 58 weeks. The primary objective of SELECTION is to evaluate the efficacy of filgotinib as compared to placebo in establishing EBS (endoscopy, bleeding, stool) remission at Week 10.
About the Galapagos – Gilead Collaboration
Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. The Phase 2 EQUATOR trial in psoriatic arthritis is one of several Phase 2 trials in inflammatory diseases that were initiated in 2017 in addition to the ongoing FINCH Phase 3 program in rheumatoid arthritis, the DIVERSITY Phase 3 trial in Crohn’s disease (also small bowel and fistulizing Crohn’s disease Phase 2 studies) and the Phase 2b/3 SELECTION trial in ulcerative colitis.
Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Galapagos’ pipeline comprises Phase 3 through to discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. Our target discovery platform has delivered three novel mechanisms showing promising patient results in, respectively, inflammatory diseases, idiopathic pulmonary fibrosis and atopic dermatitis. Galapagos is focused on the development and commercialization of novel medicines that will improve people’s lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 640 employees, operating from its Mechelen, Belgium headquarters and facilities in the Netherlands, France, Switzerland, the US and Croatia. More information at www.glpg.com.
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.
Galapagos forward-looking statements
This release may contain forward-looking statements with respect to Galapagos, including statements regarding Galapagos’ strategic ambitions, the mechanism of action and potential safety and efficacy of filgotinib, the anticipated timing of clinical studies with filgotinib and the progression and results of such studies. Galapagos cautions the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition and liquidity, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Galapagos’ results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from the ongoing and planned clinical research programs may not support registration or further development of filgotinib due to safety, efficacy or other reasons), Galapagos’ reliance on collaborations with third parties (including its collaboration partner for filgotinib, Gilead), and estimating the commercial potential of Galapagos’ product candidates. A further list and description of these risks, uncertainties and other risks can be found in Galapagos’ Securities and Exchange Commission (SEC) filings and reports, including in Galapagos’ most recent annual report on form 20-F filed with the SEC and subsequent filings and reports filed by Galapagos with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.
Gilead forward-looking statements
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 parties’ ability to complete the clinical trial programs evaluating filgotinib for the treatment of psoriatic arthritis, ulcerative colitis and other inflammatory diseases in the currently anticipated timelines, or at all. In addition, there is the possibility of unfavorable results from additional clinical trials involving filgotinib. Further, it is possible that the parties may make a strategic decision to discontinue development of filgotinib, and as a result, filgotinib may never be successfully commercialized. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. 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 March 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.
Elizabeth Goodwin, +1-781-460-1784
VP IR & Corporate Communications
Paul van der Horst, +31 71 750 6707
Director IR & Business Development
Evelyn Fox, +31 6 53 591 999
Sung Lee, +1 650-524-7792
Nathan Kaiser, +1 650-522-1853
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
GSMA: Forty CEOs Back Launch of Digital Declaration at Davos24.1.2019 08:00 | Tiedote
The GSMA today launched the ‘Digital Declaration’ at the World Economic Forum in Davos. The declaration captures key principles that serve as a guide to acting ethically in the digital era, helping companies deliver what matters most to digital citizens, industry and governments. The 40 business leaders who have already committed to the declaration span several industry sectors and include representatives from: Bharti Airtel, China Mobile, China Telecom, Deutsche Telekom, Ericsson, IBM, KDDI, KT, LG Electronics, Mobile World Capital Barcelona, Nokia, NTT DOCOMO, Orange, Samsung Electronics, Sharp, SK Telecom, Sony Corporation, STC Group, Telefónica, Turkcell, Verizon, Vodafone and Xiaomi. The initiative has arisen against a backdrop of businesses and consumers experiencing unprecedented change in the digital world. It is expected that by 2022, 60 per cent of GDP will be digitised1. The imminent arrival of 5G networks will further accelerate this change. At the same time consumers are r
Papa John’s Appoints Marvin Boakye as First Chief People Officer23.1.2019 18:02 | Tiedote
Papa John’s International, Inc., (NASDAQ: PZZA) one of the world’s largest pizza delivery companies, announced today the appointment of Marvin Boakye as its first Chief People Officer. He will serve as a member of the Papa John’s Executive Leadership Team and report to President and CEO Steve Ritchie. Boakye has more than 20 years of human resources experience, as well as expertise in change management and culture transformation. He has held human resources leadership roles for organizations across the United States, Canada and Latin America. Boakye joins Papa John’s after serving as vice president of human resources at petroleum company Andeavor in San Antonio, Texas, which was recently acquired by Marathon Petroleum. Prior to Andeavor, he was chief human resources officer for MTS Allstream, a telecommunications company now part of Bell Canada, and held senior human resources positions at Goodyear, Pulte Group and The Home Depot. “Boakye’s expertise will help us to continue to push Pa
Global Technology Association ISACA Launching Future-focused Initiatives in Its 50th Anniversary Year23.1.2019 17:22 | Tiedote
Now more than 450,000 engaged professionals and 140,000 members strong, global information technology association ISACA was founded by seven individuals as the EDP Auditing Association in California at the dawn of the information systems era—1969. Serving audit, governance, risk and cybersecurity professionals and their enterprises, today ISACA has a presence in 188 countries. Headquartered near Chicago, Illinois, USA, ISACA also established an entity in Beijing, China, last year, and acquired the CMMI Institute in 2016. In 2019—its 50th anniversary year—ISACA has adopted the theme, “Honoring Our Past. Innovating Our Future.” The organization has multiple initiatives planned to mark this milestone, including: Transforming IT Audit initiative—In February 2019, ISACA will launch a Transforming IT Audit microsite with resources to help IT auditors successfully navigate the future of the profession, including emerging areas like AI and blockchain, and featuring results from ISACA’s new glo
Wipro Ranked Third Fastest Growing Global IT Services Brand in 201923.1.2019 17:18 | Tiedote
Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, has been ranked the third fastest growing global IT services brand in 2019 in a study conducted by Brand Finance, the world’s leading brand valuation firm. Wipro is also among the top 10 most valuable brands in the global IT services sector. According to Brand Finance’s IT Services annual report for 2019, which features 15 leading brands in the segment, Wipro has a total brand value of USD 4.002 billion, up 25% on year, emerging as one of the strongest brands in the category with an AA+ Brand rating. Brand Finance, in their official press release noted that Wipro’s significant investments in digital transformation capabilities, niche acquisitions, and a recent brand refresh, have propelled it to the third fastest growing brand in the segment. The report analyses the brand value and brand strength of the 5000 largest brands across 38 sectors in t
Velodyne Lidar and YellowScan Lead Drone Surveying Market for Highway Capacity Expansion23.1.2019 16:00 | Tiedote
Velodyne Lidar, Inc. today announced that the YellowScan Surveyor from YellowScan has utilized Velodyne’s groundbreaking sensor technology to generate precise mapping data for an infrastructure construction project on one of Central Europe’s busiest roadways. YellowScan Surveyor, an unmanned aerial vehicle (UAV) surveying system, improves upon previous time-intensive manual surveying processes by providing a more efficient method for collecting landscape data with increased precision and detail. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190123005054/en/ Ventus-Tech using YellowScan Surveyor, which includes Velodyne Lidar’s Puck™, to generate precise mapping data. (Photo: Business Wire) The project was conducted by Ventus-Tech using YellowScan Surveyor to collect data along a 47-kilometer segment of the M1 highway (E60, E65, E75) in northwestern Hungary. The data, gathered by 88 UAV flights over one month, enabled engine
PMI Among Elite Group of Companies to Score A for Climate Change23.1.2019 15:00 | Tiedote
Philip Morris International Inc. (PMI) (NYSE: PM) has been highlighted as a global leader on corporate climate action by environmental impact nonprofit CDP, achieving a place on the CDP Climate Change A List for the fifth consecutive year. As the only tobacco company to have scored an A, PMI has been recognized for cutting emissions, mitigating climate risks and developing the low-carbon economy, based on its 2018 disclosure to CDP. “Climate change is one of major concerns for humanity, and companies can make a difference. Just like we are leading our industry’s transformation toward a smoke-free future, we are focused on bettering every part of our business and supply chain to become a leader in sustainable business practices,” said André Calantzopoulos, Chief Executive Officer, PMI. The company’s efforts to reduce the environmental footprint of its operations focus on sustainable design in new facilities, energy efficiency in manufacturing processes, greener purchasing of electricity
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