Galapagos says Phase III filgotinib data do not support MMA in Crohn's disease

Belgian biotech Galapagos’ (Euronext: GLPG) shares were down almost 10% at 36.73 euros this morning, after it revealed that top-line Phase III results of its already commercialized JAK inhibitor Jyseleca (filgotinib) fell short in the induction cohorts of a Crohn's disease trial, missing both co-primary endpoints and so not support a marketing authorisation application in Europe for this indication.

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 three 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.