• The two induction cohorts missed the co-primary endpoints of clinical remission and endoscopic response at Week 10
• In the maintenance phase, filgotinib 200mg once daily achieved the co-primary endpoints of clinical remission and endoscopic response at Week 58
• The safety findings were generally consistent with the known profile of filgotinib in rheumatoid arthritis (RA) and ulcerative colitis (UC)
• Galapagos decided not to submit a Marketing Authorization Application in Europe based on these topline data
• Galapagos remains fully committed to filgotinib, a JAK1 preferential inhibitor orally administered once daily, and its approved indications, RA and UC, and is on track to start a Phase 3 trial in axial spondyloarthritis (AxSpA) later this year

The co-primary endpoints at Week 10 and Week 58 were clinical remission per Patient Reported Outcome (PRO-2) and endoscopic response per Simple Endoscopic Score for Crohn’s Disease (SES-CD).

Induction Cohort A included biologic-naïve (54%) and biologic-experienced (46%) patients; induction Cohort B included biologic-experienced patients. In total, 33% of patients in Cohort A and 52% of patients in Cohort B had failed treatment with 3 or more biologic drugs.

Both induction cohorts of the study failed to meet the co-primary endpoints of clinical remission and endoscopic response for filgotinib, 100mg and 200mg once daily.

In the maintenance phase of the study, a statistically significant higher proportion of patients receiving filgotinib 200mg once daily achieved the co-primary endpoints of clinical remission (43.8% vs. 26.4%; p=0.0382) and endoscopic response (30.4% vs. 9.4%; p=0.0038) compared to placebo at Week 58.

The safety observations of the study were in line with the underlying disease and were consistent with the safety profile of filgotinib in previous studies across indications.

“While Crohn’s disease is a difficult-to-treat condition and a large proportion of patients enrolled in DIVERSITY had high disease activity and long-standing disease with prior exposure to multiple therapies, we are disappointed with the outcome of the induction studies. However, at the same time, we are encouraged by the confirmed safety profile and the clinical efficacy signs observed in the maintenance phase,” said Prof. Dr. Séverine Vermeire, Research Director of the Group Biomedical Sciences, University of Leuven and staff member at the Gastroenterology Department of the University Hospital Leuven, Belgium.

Daniele D’Ambrosio, MD, PhD, Therapeutic Area Head, Immunology, at Galapagos added: “As filgotinib demonstrated robust late-stage clinical data in UC¹ and in earlier Phase 2 clinical studies in CD, we are very disappointed with this outcome. The current topline data do not support a Marketing Authorization Application in Europe, and we will analyze the full results to gain valuable insights to guide future research efforts. Galapagos remains fully committed to filgotinib and its approved indications of RA and UC, and we are on track to initiate a Phase 3 study in patients with AxSpA later this year. We are grateful to the patients and all medical professionals who participated in this trial.”