Beglium-based Galapagos NV recently reported additional data from its Phase 2 FITZROY clinical trial assessing filgotinib, a selective JAK1 inhibitor being investigated for the treatment of Crohn’s disease.
The FITZROY trial assessed the efficacy and safety of filgotinib (200 mg once daily) versus placebo in 174 patients with moderate to severe active Crohn’s disease, either anti-TNF naive or anti-TNF failures.
In December 2015, the company reported the results from the first 10 weeks of the study, revealing that the primary endpoint of clinical remission was met. Specifically, the data showed that the percentage of patients achieving a Crohn’s Disease Activity Index (CDAI) score lower than 150 was superior in patients receiving treatment with filgotinib compared to those treated with a placebo. At week 10, there were also improvements in histopathology and in endoscopy evaluations.
The second part of the trial assessed the 20-week continued treatment, and showed that clinical responses continued from week 10 to week 20. Specifically, the non-responders in the placebo group of patients from the first 10 weeks received filgotinib (100 mg) in the second 10 weeks of the study. These patients were found to exhibit improvement in clinical remission during this second part of the trial.
There were no new safety issues reported during this part of the trial, and the most common adverse events reported were infections and nervous system and gastrointestinal disorders.
Galapagos and Gilead Sciences started a global collaboration for the development and commercialization of filgotinib for inflammatory diseases. Both companies plan to submit these 20-week results in upcoming medical meetings. In addition, Gilead plans to launch a Phase 3 clinical trial of filgotinib for the treatment of Crohn’s disease later this year.
“We are pleased by the outcome of the FITZROY study, positioning filgotinib as a potential oral treatment for patients with Crohn’s disease. The observed safety profile of filgotinib further strengthens its promising efficacy,” Piet Wigerinck, chief scientific officer at Galapagos, said in a press release. “We are proud to be advancing what could become the first new oral treatment for Crohn’s disease in decades.”
Filgotinib is the first JAK inhibitor to show efficacy in Crohn’s disease, a disease that still has few treatment options. The FITZROY study confirmed Galapagos’ growing confidence in the safety of this novel drug, so the company is moving forward in its development of filgotinib in multiple gastrointestinal indications.
Crohn’s disease is a type of inflammatory bowel disease (IBD) that may affect any part of the gastrointestinal tract, from mouth to anus. Signs and symptoms often include abdominal pain, diarrhea (which may be bloody if inflammation is severe), fever, and weight loss. Crohn’s disease is caused by a combination of environmental, immune, and bacterial factors in genetically susceptible individuals, in which the body’s immune system attacks the gastrointestinal tract.