Galapagos ( NASDAQ: GLPG ) stock fell ~8% on Thursday after filgotinib failed to meet the main goals as induction therapy in a phase 3 trial in patients with moderate to severe Crohn's disease (CD) and the company decided to not to file for European approval of the drug.
Filgotinib is sold as Jyseleca in Europe and Japan to treat certain patients with rheumatoid arthritis (RA) and ulcerative colitis (UC).
The study dubbed DIVERSITY, evaluated oral filgotinib, 100mg or 200mg once daily versus placebo, during induction and maintenance treatment, enrolling 1,374 biologic-naïve and biologic-experienced patients with CD — a type of inflammatory bowel disease.
The main goals 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 group A and 52% of patients in group B had failed treatment with 3 or more biologic drugs.
The Belgium-based company said that both induction groups of the study failed to meet the co-primary goals of clinical remission and endoscopic response for filgotinib, 100mg and 200mg.
However, in the maintenance phase of the trial, a statistically significant higher proportion of patients receiving filgotinib 200mg once daily achieved the co-primary goals of clinical remission (43.8% vs. 26.4%) and endoscopic response (30.4% vs. 9.4%) compared to placebo at Week 58.
The safety finding were in line with the underlying disease and were consistent with the safety profile of the drug in previous studies in RA and UC.
Galapagos has decided not to submit a marketing authorization application in Europe based on these results.
"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," said Daniele D'Ambrosio, Therapeutic Area head, Immunology, at Galapagos.
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Galapagos stock dips as Jyseleca fails phase 3 trial as induction therapy in Crohn's disease, cancels plans for EU filing