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
Libelium Integrates Radar Technology with its IoT Devices for Smart Parking Applications27.5.2019 11:00:00 EEST | Tiedote
Aiming to meet the growing demand for greater precision in smart parking devices, Libelium, the Spanish manufacturer of hardware and IoT solutions, has integrated radar technology in detecting the availability of parking spaces. The new Smart Parking node improves detection and stability performance thanks to a radar sensor which allows precise detection (99%) of vehicles parked over the device that sends the data to the cloud through the LoRaWAN network. IoT technology applied to the detection of parking places can reduce traffic, save fuel, decrease CO 2 emissions and improve the driving experience and habitability of cities. In addition, smart parking devices are being highly demanded by municipalities to check rotation levels in restricted parking areas (taxis, loading and unloading, recharging electric vehicles and disabled areas). First real deployment is already taking place in the city of Huesca (Northern Spain) where 190 nodes are being installed to detect the occupation of pa
Seoul Semiconductor’s SunLike Series Natural Spectrum LEDs Shown in a Recent Study to Have Beneficial Effects on Human Health and Well-being27.5.2019 11:00:00 EEST | Tiedote
Seoul Semiconductor Co., Ltd. (KOSDAQ 046890), a leading global innovator of LED products and technology, announced the results of a recent study conducted by Dr. Octavio L. Perez, adjunct researcher in Integrative Lighting at Mount Sinai Hospital in NYC, NY, USA on the non-visual melanopic stimulus of LED sources. The study showed that the company’s SunLike Series natural spectrum LEDs provide up to 21% more melanopic stimulus than conventional LEDs at 4000K, and the same melanopic stimulus as daylight at 6500K (D65). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190527005028/en/ Seoul Semiconductor's SunLike Series Natural Spectrum LEDs (Graphic: Business Wire) In addition to the visual effects of light and lighting on people, such as visual acuity and color fidelity, there are also non-visual effects. These non-visual effects can affect human health and well-being in aspects related to sleep, awakeness, alertness, circad
2019 Trends to Watch in PV Market: High-efficiency Module27.5.2019 10:00:00 EEST | Tiedote
Upon the return of SNEC PV Power Expo next month, PV InfoLink will explore the PV product trends and the transition of module output at a seminar held in Shanghai on June 3. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190527005064/en/ China's Export Destinations and Share of Special Module Exports (Graphic: Business Wire) Titled “2H19 PV Market Outlook and Forecast,” the seminar will feature topics spanning China’s transition to subsidy-free market, PV market outlook and supply chain. PV InfoLink, a leading solar market research firm and host of the seminar, has invited top-tier companies including Jinko, Longi, and GCL-Si to discuss the major issues. As the global PV market grows continuously, China’s module exports had hit a record high of 16 GW in Q1’19, a significant growth from last Q4’s 12 GW. In addition to India and Japan’s traditional high season, China exported 5 GW of modules to the European markets in Q1. Foll
A.P. Moller - Maersk Will Join Traxens27.5.2019 09:30:00 EEST | Tiedote
Traxens, a company providing high-value data and services for the supply chain industry, and A.P. Moller - Maersk (“Maersk”), the integrated container logistics company, today announced that Maersk will be joining CMA CGM and MSC Mediterranean Shipping Company as a key shareholder and customer of Traxens. Founded in 2012, Traxens has been developing unique solutions for the cargo logistics arena and has created an innovative container monitoring and coordination solution. CMA CGM first invested in the startup in 2012 and was later joined in 2016 by MSC. A milestone in the development of Traxens The agreement will see Maersk invest capital in Traxens, in which it will have similar shareholder rights as CMA CGM and MSC. Maersk also commits to order up to 50,000 Traxens devices, a similar order to those placed earlier by CMA CGM and MSC. Traxens can now further focus on strengthening its solution and drive interoperability based on non-proprietary technologies and open standards. The deve
TYAN Showcases HPC, Storage and Cloud Server Platforms Featuring 2nd Gen Intel® Xeon® Scalable Processors at Computex 201927.5.2019 05:00:00 EEST | Tiedote
TYAN®, an industry-leading server platform design manufacturer and a subsidiary of MiTAC Computing Technology Corporation, will be exhibiting a full line of HPC, storage and cloud computing server platforms that are optimized for HPC, enterprise and datacenter markets at Computex 2019 from May 28th to June 1st, Booth # L0631a in Taipei, Taiwan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190526005002/en/ TYAN's HPC, Storage and Cloud Computing Server Platforms are Optimized for HPC, Enterprise and Data Center Markets to Deliver Leading Performance (Photo: Business Wire) “The increasingly growing demand for AI is transforming the data center and is resulting in a tremendous amount of data being pulled into big data platforms at massive scale,” said Danny Hsu, Vice President of MiTAC Computing Technology Corporation's TYAN Business Unit. “TYAN’s leading portfolio of HPC, storage and cloud server platforms are based on the 2
Pioneering Project for Pharmaceutics – Vifor Pharma and the University of Basel are Jointly Establishing the World’s First Research Professorship for Nanopharmaceutical and Regulatory Science26.5.2019 10:00:00 EEST | Tiedote
Nanopharmaceutics promises ground-breaking innovation in the development of medicines: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190526005014/en/ The Vifor Pharma Group is endowing two professorships for Nanopharmaceutical and Regulatory Science at the University of Basel The commitment by Vifor Pharma and the University of Basel is aimed at ensuring Switzerland has the specialist knowledge and equipment needed to compete globally in this important emerging area of life sciences With this decision, Vifor Pharma is demonstrating its commitment to Switzerland as a world-leading location for pharmaceutical research and development Nanomedicines are playing an increasingly important role in the development of innovative new medications. These drugs are able to overcome specific cellular barriers in the human body with a view to targeting their effect even more precisely. Nanopharmacy therefore promises to help advance medic
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