- Galapagos NV GLPG announced the topline results from the DIVERSITY Phase 3 trial of filgotinib during induction and maintenance treatment of biologic-naïve and biologic-experienced patients with moderate to severe Crohn’s disease (CD).
- The co-primary endpoints at Week 10 and Week 58 were clinical remission and endoscopic response.
- 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%) 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.
- Daniele D’Ambrosio, Galapagos’ therapeutic area head in immunology, said the result comes as a disappointment as filgotinib showed “robust late-stage clinical data” in ulcerative colitis as well as in earlier Phase 2 studies for Crohn’s.
- Galapagos decided not to submit a European marketing application based on these topline data.
- Price Action: GLPG shares are down 7.87% at $40.15 on the last check Thursday.
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