Belgian clinical-stage biotechnology firm Galapagos is set to investigate filgotinib in two Phase II clinical trials for the treatment of small bowel Crohn's disease and fistulising Crohn's disease.
Filgotinib is an investigational, highly selective JAK1 inhibitor developed using the firm's target and drug discovery technology platform.
Both trials will be led by filgotinib collaboration partner Gilead Sciences.
The first multi-centre, randomised, double-blind, placebo-controlled Phase II trial will evaluate the safety and efficacy of filgotinib in adult patients with small bowel Crohn's disease for 24 weeks.
The trial will see an enrolment of around 100 patients in North America and Europe.
The trial's primary objective is to compare the clinical remission, defined as CDAI<150, of filgotinib to placebo at week 24.
The second multi-centre, randomised, double-blind, placebo-controlled Phase II trial will evaluate the safety and efficacy of filgotinib for 24 weeks, in adult patients with perianal fistulising Crohn's disease.
With plans to enrol up to 75 patients, the primary objective of the trial is to determine the efficacy of filgotinib to establish a combined fistula response at week 24 when compared to placebo.
Filgotinib is being further evaluated in the FINCH Phase III programme for rheumatoid arthritis and the SELECTION Phase IIb/III trial for ulcerative colitis.
The firm plans to also initiate the DIVERSITY Phase III trial for treating Crohn's disease.
In studies conducted in more than 1,100 patients with rheumatoid arthritis or Crohn's disease, filgotinib was found to show a rapid onset of action, efficacy, safety and tolerability.