Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support Gilead will recruit approximately 1,300 patients from the United States, Europe, Latin America, Canada, and Asia/Pacific regions. The purpose of the study is to determine whether an investigational drug called filgotinib is effective and safe for the treatment of moderate to severe Crohn’s disease. The start of the DIVERSITY study triggers a $50 million milestone payment from Gilead. Mechelen, Belgium; 10 March 2017 - Galapagos NV (Euronext & NASDAQ: GLPG) announces two new Phase 2 studies investigating filgotinib in small bowel Crohn`s disease as well as in fistulizing Crohn`s disease. In addition to ulcerative colitis, filgotinib is being evaluated by Gilead for the treatment of other inflammatory conditions including rheumatoid arthritis (FINCH Phase 3 trial), Crohn’s disease (DIVERSITY Phase 3 trial), psoriatic arthritis (PENGUIN phase 3 trials), uveitis (phase 2 trial), and small bowel and fistulizing Crohn’s disease (phase 2 trial). reports the first dosing of a patient in the DIVERSITY Phase 3 study with filgotinib in Crohn’s disease (CD). FINCH Phase 3 program with filgotinib in RA. Filgotinib 200 mg and 100 mg demonstrated a consistent safety profile in this study of MTX-IR patients, and no new safety signals were detected through Week … In more than 4,500 patient years of rheumatoid arthritis (RA) clinical study experience, filgotinib has shown favorable results in terms of onset of action, efficacy, safety, and tolerability. The DIVERSITY Phase 3 trial investigates the efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in patients with moderate to severe active disease including those with prior antibody therapy failure. In addition to the FINCH phase 3 clinical program, Gilead and Galapagos NV have several others in place for filgotinib, including the phase 3 SELECTION trial in ulcerative colitis, the DIVERSITY phase 3 trial in Crohn’s disease, and the phase 3 PENGUIN trials in psoriatic arthritis; phase 2 studies in uveitis and in small bowel and fistulizing Crohn’s disease are also underway. First patient dosed triggers $50 million milestone payment Mechelen, Belgium; 22 November 2016 - Galapagos NV reports the first dosing of a patient in the... | April 6, 2021 Data will be collected by the clinical sites and patients using an electronic case report form (eCRF) and mobile devices. The latest company information, including net asset values, performance, holding & sectors weighting, changes in voting rights, and directors and dealings. Filgotinib was discovered and developed by Galapagos using our proprietary target and drug discovery technology platform. The only place for free North American stock rankings incorporating insider commitment. The start of the DIVERSITY study triggers a $50 million milestone payment from Gilead. Home of the insider insights newsletter and the Canadian Insider Club which offers alerts and premium research. Galapagos NV has reported that the successful completion of discussions with the regulatory authorities in the US and Europe to initiate the DIVERSITY Phase 3 study in Crohn’s disease and the SELECTION Phase 2b/3 study in ulcerative colitis with filgotinib. In August 2016, Gilead initiated the FINCH global Phase 3 program investigating the efficacy and safety of 100 mg and 200 mg filgotinib once daily, in RA patient populations, ranging from early stage to biologic-experienced patients:. The worldwide DIVERSITY Phase 3 study will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in 1,320 … The worldwide DIVERSITY Phase 3 study will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in 1,320 patients with moderately to severely active Crohn's disease, including those with prior biological therapy failure. The worldwide DIVERSITY Phase 3 study will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in 1,320 patients with moderately to severely active Crohn's disease, including those with prior biological therapy failure. This study is currently recruiting participants. Regulated information 22 November 2016, 22.00 CET Phase 3 study... | April 5, 2021 This triggered a … Authors Mark C Genovese 1 , Kenneth Kalunian 2 , Jacques-Eric Gottenberg 3 , Neelufar Mozaffarian 4 , Beatrix … The worldwide DIVERSITY Phase 3 study will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in 1,320 patients with moderately to severely active Crohn's disease, including those with prior biological therapy failure. MECHELEN, Belgium, Nov. 22, 2016 -- Galapagos NV (Euronext NASDAQ: GLPG) reports the first dosing of a patient in the DIVERSITY Phase 3 study with filgotinib … Under the terms of the amended agreement, Galapagos will assume operational responsibility for ongoing clinical trials evaluating filgotinib in RA. The worldwide SELECTION Phase 2b/3 study will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in 1,300 patients with moderately to severely active disease, including those with prior biological therapy failure. The DIVERSITY Phase 3 study in Crohn's disease with filgotinib started in November. The companies have multiple clinical study programs for filgotinib in inflammatory diseases, including the FINCH Phase 3 program in rheumatoid arthritis, the Phase 3 … About the FILOSOPHY Phase 4 studyFILOSOPHY (FILgotinib Observational Study Of Patient Health related outcomes over 2 Years), is a prospective, non-interventional cohort study enrolling approximately 1500 patients across Europe. Get stock quotes, news, fundamentals and easy to read SEC and SEDI insider filings. Gilead initiated the FINCH Phase 3 study in rheumatoid arthritis in August, the DIVERSITY Phase 3 study in CD in November and the SELECTION Phase 2b/3 program in ulcerative colitis earlier this month. Filgotinib in the Induction and Maintenance of Remission in Adults with Moderately to Severely Active Crohn's Disease. Filgotinib is an investigational drug and its efficacy and safety have not been established. Galapagos NVGLPG announced that it has dosed the first patient in a phase III study - DIVERSITY - on filgotinib for the treatment of Crohn's disease. The start of the DIVERSITY study triggers a $50 million milestone payment from Gilead. Filgotinib Development. 28,29 Filgotinib was also shown to exhibit good in vitro ADME properties, high oral bioavailability in animals, and was efficacious in a mouse DSS-induced colitis model. The start of the DIVERSITY study triggers a $50 million milestone payment from Gilead. This study is being led by filgotinib collaboration partner Gilead Sciences, Inc. “We are very excited with the initiation of this Proof-of-Concept study with filgotinib in CLE. The start of the DIVERSITY study triggers a $50 million milestone payment from Gilead. This study focuses on individuals diagnosed with Crohn’s disease, an inflammatory disease of the gastrointestinal tract (digestive tract). About the FITZROY study and results Filgotinib is a selective JAK1 inhibitor with a human whole blood EC 50 of 629 nM, displaying a 30-fold cellular selectivity for JAK1 over JAK2. The DIVERSITY study will investigate two doses of filgotinib (100 mg and 200 mg) once-daily compared to a placebo in 1,230 patients, including those with prior biological therapy failure. The worldwide DIVERSITY Phase 3 study will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in 1,320 patients with moderately to severely active Crohn's disease, including those with prior biological therapy failure. The first additional Crohn’s disease study is a Phase 2, double-blind, randomized, placebo-controlled clinical trial (NCT03046056) evaluating the effectiveness and safety of filgotinib in the treatment of small bowel Crohn’s disease (SBCD). 2019 Jul 23;322(4):315-325. doi: 10.1001/jama.2019.9055. Effect of Filgotinib vs Placebo on Clinical Response in Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy: The FINCH 2 Randomized Clinical Trial JAMA. The worldwide DIVERSITY Phase 3 study will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in 1,320 …
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