First patients dosed with filgotinib for Crohn's disease in Phase III DIVERSITY study.- Gilead + Galapagos

Galapagos NV reports the first dosing of a patient in, the DIVERSITY Phase III study with filgotinib in Crohn's disease (CD). The start of the DIVERSITY study triggers a $50 million milestone payment from Gilead.

The worldwide DIVERSITY Phase III study will investigate efficacy and safety of 100 mg and 200 mg filgotinib once-daily compared to placebo in 1,320 patients with moderately to severely active Crohn's disease, including those with prior biological therapy failure. Gilead and Galapagos will enroll 1,320 subjects with moderately to severely active Crohn's disease, including patients who have used drugs such as Johnson & Johnson's Remicade and Takeda's Entyvio without success. Over the first 10 weeks, participants will receive one of two doses of filgotinib including the 200-mg dose linked to testicular toxicity or a placebo. Subjects who achieve clinical remission or endoscopic response will advance into a maintenance study, in which they will take daily doses of filgotinib or a placebo for 58 weeks. The maintenance trial is also primarily looking at rates of clinical remission and endoscopic response.

Gilead and Galapagos expect to complete the trial late in 2019.

Comment: Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. In addition to the DIVERSITY study, Gilead initiated the FINCH Phase III program in rheumatoid arthritis in August 2016 and is expected to start the SELECTION Phase IIb/III study in ulcerative colitis later this quarter.