Galapagos NV a clinical-stage biotechnology company specializing in the discovery and development of small molecule medicines with novel modes of action, recently announced the last patient randomisation in their Phase 2 clinical trial for Crohn’s disease called FITZROY.
The trial is assessing the safety and efficacy of filgotinib, a Janus kinase inhibitor with selectivity for subtype JAK1 of this enzyme. It is considered a promising agent as it inhibits JAK1 selectively. The study involves 20 weeks of treatment with the drug in 175 patients with a diagnosis of Crohn’s disease.
Filgotinib is the first drug that inhibits JAK1 selectively for the treatment of Crohn’s disease. This Phase 2 clinical trial is evaluating the induction of disease remission and also exploring early maintenance of filgotinib effects. Based on the results, the drug agent could rapidly enter into Phase 3 clinical trials. Galapagos is funding and conducting the trial. Patient recruitment was sought from 66 centers across 9 countries in Eastern and Western Europe.
The company is expecting to announce the study’s primary endpoint results after 10 weeks of treatment in December, and 20-week treatment results during the first trimester of 2016. The Phase 2 clinical trial of filgotinib for the treatment of Crohn’s disease is being conducted in parallel with the DARWIN Phase 2B study of the drug agent in patients with rheumatoid arthritis (RA).
The company is expecting to announce the final results in August 2015, after 24 weeks of treatment from the second DARWIN study, which is assessing the efficacy and safety of filgotinib in a monotherapy setting.
Currently, AbbVie holds full license rights of filgotinib upon its receipt of the final data package from the Phase 2B RA clinical trials.
If AbbVie in-licenses filgotinib after receipt of the full data package from the DARWIN 1 and DARWIN 2 Phase 2B trials in patients with RA, Galapagos will be qualified to obtain a $50 million payment if AbbVie chooses to move forward with filgotinib for the treatment of Crohn’s disease following receipt of the complete data set from the Crohn’s clinical trial.