Phase 3 Data on Filgotinib in Biologic-Experienced Rheumatoid Arthritis to Be Presented at 2018 ACR/ARHP Annual Meeting
Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced detailed results from the Phase 3 FINCH 2 clinical trial of filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response or intolerance to biologic agents. The data, which are being presented as a late-breaking poster at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, suggest filgotinib has a potential role in addressing important unmet needs in the treatment of rheumatoid arthritis.
Positive efficacy data from FINCH 2 were previously announced in September 2018. The data show statistically significant improvements in the proportion of patients achieving a range of clinical efficacy endpoints, including the proportion of patients achieving American College of Rheumatology 20 percent (ACR20, primary endpoint), 50 percent (ACR50) and 70 percent (ACR70) responses, low disease activity (defined as DAS28(CRP) ≤ 3.2) and clinical remission (defined as DAS28(CRP) < 2.6) at Weeks 12 and 24.
Additional FINCH 2 data to be presented include positive results across several patient-reported health-related quality of life measures. Patients receiving filgotinib 100mg or 200mg once-daily experienced greater reduction in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 compared with those receiving placebo (-0.46 and -0.50 vs -0.19; both p<0.001). Patients receiving filgotinib 100mg or 200mg also experienced greater improvements on the Short-Form Health Survey (SF-36) Physical Component Score (PCS) at Week 12 (7.6 and 8.4 vs 4.2; both p<0.001) and on the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-Fatigue) at Week 12 (8.4 and 10.2 vs 5.2; p=0.007 and p<0.001) compared with patients receiving placebo.
Filgotinib demonstrated a safety profile consistent with earlier clinical trials. Rates of serious treatment-emergent adverse events were similar for the filgotinib 100mg, 200mg and placebo groups (5.2 percent, 4.1 percent and 3.4 percent, respectively). The proportion of patients who discontinued study drug due to treatment-emergent adverse events was also similar across groups. Serious infections occurred at similar rates across the three study arms (2.0 percent, 0.7 percent and 1.4 percent, respectively). A total of four cases of uncomplicated Herpes zoster occurred in the filgotinib arms, and one non-serious case of retinal vein occlusion was reported in the filgotinib 200 mg group. Two major adverse cardiovascular events were reported, one in the filgotinib 100mg group and one in the placebo group. No deaths occurred during the study.
“Inflammatory diseases are an important area of focus for Gilead’s research and development and filgotinib is a cornerstone of this work,” said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. “The results of FINCH 2 add further support to the potential role of filgotinib in treating patients with rheumatoid arthritis.”
“For many people living with rheumatoid arthritis, the effects of pain, inflammation and fatigue can take a serious toll in their everyday lives. We are encouraged by these data, which suggest filgotinib can improve symptoms of rheumatoid arthritis in patients who have not responded to prior biologic treatment and who need new therapies that are safe and effective,” said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos. “We are committed to developing filgotinib to address the unmet needs of these patients.”
Filgotinib is an investigational compound and is not approved anywhere globally. Its efficacy and safety have not been established. For information about the clinical trials with filgotinib: www.clinicaltrials.gov.
About the FINCH 2 Trial
FINCH 2 was a global, 24-week, randomized, double-blind, placebo-controlled, Phase 3 study evaluating daily oral filgotinib on a background of conventional synthetic disease-modifying anti-rheumatic drug(s) (csDMARDs) in adult patients with moderately-to-severely active rheumatoid arthritis who had not adequately responded (or were intolerant) to prior biologic DMARDs (bDMARDs). In this study, 23.4 percent of patients had received three or more bDMARDs. Patients were randomized (1:1:1) to receive filgotinib 100 mg, filgotinib 200 mg or placebo. The primary endpoint was the proportion of patients achieving an ACR20 response at Week 12. Treatment-emergent adverse events are those reported during the study or within 30 days of the last dose of study drug.
For information about clinical trials with filgotinib: www.clinicaltrials.gov.
About the Galapagos – Gilead Collaboration
Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. Ongoing clinical studies include the FINCH Phase 3 program in rheumatoid arthritis, the DIVERSITY Phase 3 trial in Crohn’s disease, the Phase 2b/3 SELECTION trial in ulcerative colitis and Phase 2 studies in small bowel and fistulizing Crohn’s disease, psoriatic arthritis, ankylosing spondylitis, Sjogren’s syndrome, lupus and uveitis.
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 inflammation, fibrosis, cystic 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. Our ambition is to become a leading global biopharmaceutical company, focused on the development and commercialization of innovative medicines that will improve people’s lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 675 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 Statement
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 filgotinib. 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 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 the possibility of unfavorable results from ongoing and additional clinical trials involving filgotinib and the possibility that we are unable to complete one or more of such trials on the currently anticipated timelines. 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 June 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.
Elizabeth Goodwin, +1-781-460-1784
VP IR & Corporate Communications
Sofie Van Gijsel, +32 485 191415
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
Manifesto: Call for a Successful Transition to Renewables in the Transportation Sector21.11.2018 16:04 | Tiedote
Political course corrections, coupled with the alarming reports on climate conservation, have led the organizers behind Power2Drive and other endorsers to initiate a manifesto. The aim is to deepen the close connection between e-mobility and renewable sources of energy and achieve a sustainable future. The smarter E Europe, the largest energy industry platform in Europe, will demonstrate the potential held by this combination of mobility and clean energy, and the pressing need to pay greater attention to sector coupling. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181121005307/en/ Survey shows: Solar power for refuelling is popular (© Solar Promotion GmbH & Bundesverband Solarwirtschaft e.V. BSW) The organizers behind Power2Drive have formed a strong alliance committed to the idea of a successful transition to renewable sources of energy in the transportation sector. Some of the declaration’s first signatories include the
Knopp Biosciences to Present at the Piper Jaffray 30th Annual Healthcare Conference21.11.2018 14:00 | Tiedote
Knopp Biosciences LLC, a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases of high unmet need, today announced that management will present at the Piper Jaffray 30th Annual Healthcare Conference to be held in New York, NY on November 27-29. Michael Bozik, M.D., President and CEO of Knopp Biosciences, is scheduled to present on Tuesday, November 27th at 12:50 p.m. Eastern Time. ABOUT KNOPP BIOSCIENCES LLC Knopp Biosciences is a privately held drug discovery and development company focused on delivering breakthrough treatments for inflammatory and neurological diseases of high unmet need. Knopp’s clinical-stage small molecule, dexpramipexole, is entering Phase 3 clinical studies in hypereosinophilic syndrome and Phase 2 clinical studies in eosinophilic asthma. Knopp’s preclinical Kv7 platform is directed to small molecule treatments for neonatal epileptic encephalopathy, other rare epilepsies, ti
REPLY: Syskoplan Reply Awarded with the SAP Quality Award in the Innovation Category21.11.2018 12:00 | Tiedote
Syskoplan Reply, the SAP technology specialist within the Reply Group, has been awarded with the SAP Quality Award from SAP in the Innovation category for a project for the SEA Group. The award honors the latest SAP solutions and it is presented annually at the SAP NOW event. Syskoplan Reply receives the renowned award for the fifth time in a row. The gold award winning project is an innovative SAP Hybris Marketing solution for SEA from Syskoplan Reply. The SEA Group manages both Milan Linate and Milan Malpensa airports and provides all services and related activities. The project consists of implementing SAP Hybris Marketing to design, create and monitor marketing initiatives. The aim is to increase the customer experience of passengers at Milan Malpensa Airport and make their stay a special experience. The cross-departmental, effective marketing campaign is based on the concept of gamification: in the multi-channel campaign, passengers can participate in a treasure hunt "Hashtag Hunt
GSMA Launches New Industry-Wide Initiative to Support Development of Operator Edge Cloud AR/VR21.11.2018 12:00 | Tiedote
The GSMA today announced the launch of a new industry-wide initiative called The GSMA Cloud AR/VR Forum that will focus on the development of cloud virtual reality (VR) and augmented reality (AR) technology. The programme which was unveiled at Huawei’s 9th Global Mobile Broadband Forum in London, is backed by mobile operators including China Mobile, China Telecom, China Unicom, Deutsche Telekom, KDDI, KT Corp., NTT DOCOMO, SK Telecom, Telefónica, Telenor, TIM, Turkcell and Vodafone, as well as other industry partners including Huawei and HTC. The programme aims to encourage all parties to collaborate on accelerating the delivery and deployment of 5G cloud-based AR/VR services. “Both VR and AR are disruptive forms of immersive multimedia that, combined with operator edge cloud and 5G connectivity, will transform the cost structures of the enterprise and entertainment fields,” commented Alex Sinclair, Chief Technology Officer, GSMA. “Mobile operators will play a key role in its developme
Clientron to exhibit its embedded computing innovations at SPS IPC Drives 201821.11.2018 12:00 | Tiedote
Clientron Corp., a world-leading supplier of embedded systems, will introduce its intelligent embedded solutions including single board computers, embedded box PC, and industrial panel PC at SPS IPC Drives 2018, taking place at the Exhibition Centre Nuremberg (No.8-512, Hall 8) from 27 to 29 November in Nuremberg, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181121005002/en/ Clientron to exhibit its brand new intelligent embedded systems at SPS IPC Drives 2018 (Photo: Business Wire) The SPS IPC Drives is the leading trade fair for electronic automation solutions. At the show, Clientron will proud to illustrate its embedded computing solutions for factory automation and food industry applications. The advantages of Clientron’s products are designed for high quality, durability, flexibility and maximum compatibility to facilitate the business transformation towards Industry 4.0. During the show, Clientron will intro
Wireless charging makes a world’s first debut on South Western Railway trains in the UK.21.11.2018 12:00 | Tiedote
Baker Bellfield, one of the UK’s leading suppliers of commercial interior solutions for the rail sector, and Aircharge, global leader in wireless charging solutions for contract use, have announced today the launch of the world’s first fully rail compliant inductive phone wireless charging system. On-train wireless charging will debut on South Western Railway’s (SWR) refurbished and reconfigured class 444 Siemens Desiro five-car EMUs on the London Waterloo – Southampton – Bournmouth – Weymouth route from November 2018. When the refurbishment programme is completed, all 172 of SWR Desiro class trains will have this new feature. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181121005180/en/ The Aircharge - Baker Bellfield mobile phone wireless charging solution for trains (Photo: Business Wire) With mobile devices becoming the best travel companions for personal and business purposes, including the use of mobile check-in appl
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