pe26 schreef op 7 februari 2018 08:25:
Versnelling in het reumatoïde artritis (RA) programma Filgotinib,
molecuul uitgevonden door Galapagos en uit-gelicenserd aan Gilead.Norbert W. Bischofberger - Gilead Sciences, Inc.
We also made great progress in inflammation. Five Phase 3 studies of filgotinib are ongoing in patients with rheumatoid arthritis, ulcerative colitis and Crohn's disease. Three studies, FINCH 1, 2 and 3, are being conducted in rheumatoid arthritis. The FINCH 2 study is fully enrolled, and we anticipate data from this study in the second half of 2018 (pe26: was bekend)
. FINCH 2 compared filgotinib to placebo each added to conventional disease-modifying antiarrhythmic drugs, or DMARDs, in patients who have had inadequate response to biologics.
Other studies in rheumatoid arthritis include FINCH 1, a 52-week randomized study comparing filgotinib plus methotrexate to adalimumab plus methotrexate to methotrexate alone in patients who have had inadequate response to methotrexate. And FINCH 3, a 52-week randomized study comparing filgotinib alone to methotrexate alone to the combination of filgotinib plus methotrexate in methotrexate-naive patients. We anticipate the FINCH 1 and FINCH 3 studies to be fully enrolled later this year.
Filgotinib is also being investigated in five additional Phase 2 studies in other inflammatory diseases, namely psoriatic arthritis, ankylosing spondylitis, lupus, Sjogren's syndrome, and uveitis and we should have data available from some of these studies later this year. John F. Milligan - CEO Gilead Sciences, Inc.
We continue to be enthusiastic about filgotinib.
In the ongoing Phase 3 studies, we are looking to see if the potential safety and efficacy advantages of a selective JAK1 inhibitor seen in pre-clinical and early clinical studies are borne out in these trials. In addition, Gilead's exploring five additional indications beyond rheumatoid arthritis, ulcerative colitis and Crohn's disease.seekingalpha.com/article/4143778-gile...
FINCH 3 is belangrijk. Deze RA studie heeft de langste looptijd. Timeline FINCH 3 studie:
>Eind 2018 werving van alle patiënten
>Augustus 2019 volgen de 24-weeks primary scores (analyse-tijd inbegrepen).
Eerder was geschat dat primary scores feb. 2020 zouden volgen.
Sprake van halfjaar winst.clinicaltrials.gov/ct2/show/NCT028867...
Speed up the development. Dat is wat gebeurd. Positief.