Gilead, Galapagos See Sustained Efficacy, Safety for Filgotinib

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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