Belgium-based clinical-stage biotechnology company Galapagos has begun its DIVERSITY Phase III study of filgotinib to treat Crohn’s disease (CD).
Filgotinib is a highly selective, Janus kinase 1 (JAK1) inhibitor discovered and developed by Galapagos using its target and drug discovery technology platform.
Crohn's disease is an inflammatory bowel disease (IBD) that causes the inflammation of the lining of the digestive tract, leading to abdominal pain, severe diarrhea, fatigue, weight loss and malnutrition.
The inflammation often spreads deep into the layers of affected bowel tissue.
The Phase III DIVERSITY study is being conducted to assess the safety and efficacy of 100mg and 200mg filgotinib to be administered on a once-daily basis compared to placebo.
The study has enrolled 1,320 patients suffering from moderately to severely active Crohn’s disease, including those with prior biological therapy failure.
The start of the DIVERSITY study will also result to a $50m milestone payment from Gilead.
Galapagos chief scientific officer Dr Piet Wigerinck said: “With the FITZROY Phase II study, Galapagos demonstrated that filgotinib has a promising efficacy and safety profile in Crohn’s disease.
“The start of the Phase III DIVERSITY study is good news for patients with Crohn’s disease.”
Last year, Galapagos and Gilead entered into a global collaboration to develop and commercialise filgotinib in inflammatory indications, under which the companies began a Phase III trial in rheumatoid arthritis (RA) and Crohn’s disease.