Oral Alternative: Filgotinib

Promising IBD Treatment Filgotinib is Recruiting for Phase 3 Clinical Trials

Belgian pharmaceutical company Galapagos is developing filgotinib, examining its effects on both Crohn’s Disease and UC.

What is Filgotinib?

Filgotinib is a new oral therapy showing efficacy in the treatment of inflammatory indications like rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. Originally developed by biopharmaceutical company Galapagos, filgotinib is now being developed and commercialized in a global collaboration between Galapagos and biotech company Gilead.

So far, Galapagos reports that filgotinib has proven itself to have rapid onset of action, best-in-class efficacy, and positive safety and tolerability results.

What does Filgotinib do?

Filgotinib is part of a class of drugs known as Janus kinase (JAK) inhibitors. JAK inhibitors interfere with the immune response by blocking the actions of a specific family of proteins, dampening the response of pro-inflammatory cytokines involved in IBD. This occurs when the JAK inhibitor molecules bind to the JAK receptor, blocking the intercellular signalling that would otherwise lead to immune cell proliferation and inflammation.

Filgotinib is one of two JAK1-selective inhibitors currently being tested for treatment of IBD (the other being upadacitinib, from biopharmaceutical company AbbVie). JAK1-selective inhibitors are some of the most advanced IBD treatments being developed today. Both filgotinib and upadacitinib selectively target the JAK1 pathway, a signalling pathway that plays an important role in immune disorders.

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Researchers from Galapagos have observed that, by specifically targeting JAK1 instead of the entire JAK signalling pathway, this IBD therapy may decrease the risk of a patient developing anemia (a major concern for IBD patients who are already prone to blood loss).

JAK inhibitors are believed to have certain advantages over other agents because of their oral delivery and small molecular size. It’s speculated that filgotinib will benefit from reduced production costs. Another benefit of this drug for patients is the convenience of an orally administered therapy—likely to be a welcome alternative for patients considering injection or infusion treatments.

Studies on Filgotinib

Biopharmaceutical company Gilead has led a number of clinical trials on filgotinib. Already having performed Phase 2 trials in small bowel Crohn’s Disease and fistulizing Crohn’s Disease, they began Phase 3 trials in late 2016.

The most recent Phase 3 study called DIVERSITY is still underway, and Gilead says that they expect to finish recruiting for the trial in 2019.

So far, trials have shown high activity and a favourable safety profile, and Galapagos reports that filgotinib may show activity and tolerability in UC patients as well.

What is Filgotinib’s Current Status?

Phase 3 trials for filgotinib were initiated in 2016 for both Crohn's disease and ulcerative colitis, along with Phase 2 studies in small bowel Crohn’s disease and fistulizing Crohn’s disease.

In Phase 3 trials, clinical researchers and physicians are testing the drug on patients to assess its efficacy, safety, and dosing. Already having shown that the drug is safe and has an effect, the ultimate goal in Phase 3 trials is to evaluate drug’s therapeutic effect (on anywhere between 300 and 3,000 patients) before making it available on the market.

How Can I Learn More About Filgotinib?

Learn more about filgotinib and determine whether you can participate in a clinical trial near you by taking a short quiz on the DiscoverTherapies.com.

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L.C.S. De Vries, M.E. Wildenberg, W.J. De Jonge, G.R. D’Haens; The Future of Janus Kinase Inhibitors in Inflammatory Bowel Disease, Journal of Crohn's and Colitis, 11(7), 885–893 1 July 2017,, https://doi.org/10.1093/ecco-jcc/jjx003
(2018). Galapagos NV. Our filgotinib program in inflammatory bowel disease (IBD). Retrieved from http://reports.glpg.com/annual-report-2017/en/r-d/filgotinib/inflammatory-bowel-disease/our-filgotinib-program-in-ibd.html
(2018). Galapagos NV. Filgotinib. Retrieved from http://www.glpg.com/filgotinib

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