Galapagos Begins Phase 2b/3 Clinical Trial of Filgotinib in Ulcerative Colitis Patients

Galapagos Begins Phase 2b/3 Clinical Trial of Filgotinib in Ulcerative Colitis Patients

Galapagos NV recently announced that it has dosed the first patient with ulcerative colitis (UC) in its SELECTION Phase 2b/3 clinical trial, investigating the efficacy and safety of two doses of filgotinib as a UC treatment.

SELECTION  (NCT02914522) is investigating two doses of filgotinib (100 mg and 200 mg filgotinib once daily), compared to placebo, as an induction and maintenance treatment for people with moderately to severely active ulcerative colitis. The trial is currently recruiting participants, including those who have failed to respond to previous treatments with biologics.

In total, about 1,300 patients will be recruited from across the U.S., Europe, Latin America, Canada, and Asia/Pacific. This trial will include an interim analysis, which will serve as its Phase 2b part. Its primary goal is the proportion of patients achieving remission, based on Mayo Clinic Score components, at week 10 in the study’s induction phase, and the proportion achieving remission at week 58 in its maintenance phase.

In the U.S., men will be treated with 200 mg of filgotinib if they failed at least one previous biological therapy. The Phase 3 program of filgotinib also will incorporate a testicular safety analysis.

The trial’s initiation triggered a $10 million milestone payment from Gilead Sciences to Galapagos. The companies are collaborating in the development and commercialization of filgotinib in multiple inflammatory indications.

In addition to SELECTION, Galapagos is conducting DIVERSITY, a Phase 3 clinical trial (NCT02914561) investigating the two doses of filgotinib (100 mg and 200 mg) once daily compared to a placebo in 1,230 patients with Crohn’s disease, including those who have failed prior biological therapies. Participants who complete the study – or who do not meet protocol response or remission criteria at week 10 – will have the option to enter a separate long-term extension (LTE) study (NCT02914600).

“Our collaboration partner Gilead is definitely keeping up the speed in rolling out studies with filgotinib,” Piet Wigerinck, CSO of Galapagos, said in a recent press release.  “We look forward to seeing the results of both the DIVERSITY and SELECTION studies in inflammatory bowel disease.”

In addition to these two studies, Gilead initiated the FINCH Phase 3 program investigating filgotinib in rheumatoid arthritis in August.

Filgotinib is a selective inhibitor of the JAK1 (Janus kinase 1), an enzyme involved in the signaling pathways of several pro-inflammatory cytokines, ultimately leading to inflammation, and causing inflammatory bowel diseases (IBD) such as Crohn’s and ulcerative colitis.