Gilead, Galapagos See Sustained Efficacy, Safety for Filgotinib
October 12 2020 - 10:06AM
Dow Jones News
By Chris Wack
Gilead Sciences Inc. and Galapagos NV said Monday that data
demonstrated sustained efficacy and safety with filgotinib, a
treatment for moderately to severely active ulcerative colitis.
The companies said the data from the Phase 2b/3 trial showed
that a significantly higher proportion of patients treated with
filgotinib 200 mg, versus placebo, achieved clinical remission at
Week 10 and maintained remission through Week 58. Also,
significantly more patients achieved six-month corticosteroid-free
remission. Ulcerative colitis is a long-term condition
characterized by inflammation of the mucosal lining of the colon
and rectum.
The study results showed that filgotinib reduced bleeding and
stool frequency while also achieving remission across a range of
measures, including endoscopy and histology, in an oral
formulation.
Overall, 1,348 biologic-naive or biologic-experienced adult
patients with moderately to severely active UC were randomized and
treated in the study.
Overall, the incidence of adverse events and discontinuations
due to adverse events were similar in the filgotinib and placebo
groups in both the induction and maintenance periods of the study.
Serious infections, herpes zoster, venous thrombosis, pulmonary
embolism and gastrointestinal perforation were infrequent and
comparable across treatment groups. Two deaths were observed in the
filgotinib 200 mg treatment group in the maintenance trial, but
both adverse events leading to deaths were considered by the study
investigators to be unrelated to study drug.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
October 12, 2020 09:51 ET (13:51 GMT)
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