Gilead and Galapagos' filgotinib meets endpoints in ulcerative colitis study
May 20, 2020 4:28 PM ET|About: Galapagos NV (GLPG)|By: Douglas W. House, SA News Editor
Galapagos NV (NASDAQ:GLPG) and collaboration partner Gilead Sciences (NASDAQ:GILD) announce results from a Phase 2b/3 clinical trial evaluating filgotinib in 1,348 biologic-naïve or biologic-experienced adult patients with moderately to severely active ulcerative colitis (UC).
The 200 mg arm met the two primary endpoints demonstrating statistically significant proportions of treated patients achieving remission at week 10 and maintaining remission at week 58, both compared to placebo.
In biologic-naïve patients, 26.1% achieved clinical remission at week 10 versus 15.3% in the control arm (p=0.0157). In biologic-experienced patients, the proportions were 11.5% and 4.2%, respectively (p=0.0103).
The 100 mg arm failed to meet the week 10 endpoint.
At week 58, both dose arms met the primary endpoint. Specifically, 37.2% of biologic-naïve and biologic-experienced patients receiving 200 mg achieved remission compared to 11.2% for placebo (p<0.0001). In the 100 mg arm, 23.8% met the endpoint versus 13.5% for placebo (p=0.0420).
On the safety front, in the induction trial, the rates of serious adverse events in biologic-naïve patients in the 100 mg, 200 mg and control arms were 4.7%, 1.2% and 2.9%, respectively). The rates were 5.3%, 7.3% and 6.3%, respectively, in biologic-experienced patients.
In the maintenance phase, 4.5% of patients in the 200 mg group experienced a serious adverse event versus 0% for control. The rate was also 4.5% in the 100 mg group versus 7.7% for placebo.
Detailed results will be submitted for presentation at a future medical conference.
GILD is down 1% after hours while GLPG is down 3%.