The Future of Crohn's and Colitis Medications

New Inflammatory Bowel Disease (IBD) treatments are working their way through the pipeline, showing promise as alternatives to the anti-TNF agents that have dominated the IBD therapy landscape for the past 20 years. Oral medications Ozanimod, Upadacitinib and Filgotinib are among the novel IBD therapies to keep on the radar as they move through clinical trials.

Learn about these new IBD treatments for Crohn’s and ulcerative colitis (UC)—and gain early access to these new IBD medications by participating in clinical trials.

Ozanimod

Developed to treat several autoimmune conditions, Ozanimod was discovered by scientists at The Scripps Research Institute, who have partnered with biopharmaceutical company Celgene to bring the drug through trials and FDA approval.

Ozanimod is a sphingosine 1-phosphate 1 (S1PR1) receptor antagonist. By inhibiting the S1PR1 receptor, Ozanimod modulates the body’s immune response by decreasing the number of lymphocytes in the gastrointestinal tract.

In studies on Ozanimod and IBD, researchers have concluded that Ozanimod is well tolerated and is a promising treatment for chronic inflammatory diseases, including both Crohn’s Disease and UC.

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Crohn's Disease Ulcerative Colitis

Ozanimod has just entered into Phase 3 clinical trials for Crohn’s Disease in early 2018, and Phase 3I trials for UC are underway.

Upadacitinib (or ABT494)

From biopharmaceutical company AbbVie, upadacitinib is in Phase 3 trials for Crohn’s Disease and is also being investigated as a potential treatment for ulcerative colitis. Specifically, it is being investigated for moderate to severe Crohn’s disease and in patients with inadequate response to an immunomodulator treatment or anti-TNF therapy.

Upadacitinib is part of a class of molecules known as Janus kinase (JAK) inhibitors. JAK inhibitors interfere with key pro-inflammatory cytokines involved in IBD. Upadacitinib is a JAK1-selective inhibitor, meaning that it selectively targets the JAK1 pathway, which plays an important role in immune disorders. Several other IBD treatments being developed target Janus kinases, including Filgotinib (also a JAK1 inhibitor) and Tofacitinib (a pan-JAK inhibitor).

In February 2018, AbbVie announced results from a Phase 2 study called CELEST, which showed that patients who achieved clinical response after the 16-week induction phase maintained their response over the following 9 months.

Filgotinib

Belgian pharmaceutical company Galapagos is developing filgotinib, examining its effects on both Crohn’s Disease and UC. Like upadacitinib, filgotinib is a JAK1 inhibitor. 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).

Biopharmaceutical company Gilead has been leading 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.

A 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 favorable safety profile, and Galapagos reports that filgotinib may show activity and tolerability in UC patients as well.

Clinical Trials for New IBD Treatments

In many cases, these novel IBD therapies are being tested on both new patients and patients who have already tried other therapies, such as immunomodulators, anti-TNFs, and monoclonal antibodies.

Patients searching for Crohn’s treatment options or new ulcerative colitis treatments can gain exclusive access to these IBD treatment options before they hit the market by participating in a trial. Check your eligibility by completing a quiz at Discover Therapies.

References:
(2018). Ozanimod Successful in Clinical Trials for Multiple Sclerosis. The Scripps Research Institute. Retrieved from https://www.scripps.edu/news/press/2017/20171109ozanimod.html
Ostrowski, Jeff. (2017 November 10). Scripps hopes for royalty windfall from potential blockbuster drug. myPalmBeachPost. Retrieved from https://www.mypalmbeachpost.com/business/scripps-hopes-for-royalty-windfall-from-potential-blockbuster-drug/R8umNRqVcrDA2WpdjnBERI/.
Scott, F. L., Clemons, B., Brooks, J., Brahmachary, E., Powell, R., Dedman, H., … Peach, R. J. (2016). Ozanimod (RPC1063) is a potent sphingosine‐1‐phosphate receptor‐1 (S1P1) and receptor‐5 (S1P5) agonist with autoimmune disease‐modifying activity. British Journal of Pharmacology, 173(11), 1778–1792. http://doi.org/10.1111/bph.13476
Tran, J. Q., Hartung, J. P., Peach, R. J., Boehm, M. F., Rosen, H., Smith, H., … Frohna, P. A. (2017). Results From the First‐in‐Human Study With Ozanimod, a Novel, Selective Sphingosine‐1‐Phosphate Receptor Modulator. Journal of Clinical Pharmacology, 57(8), 988–996. http://doi.org/10.1002/jcph.887
Lee, H. S., Park, S.-K., & Park, D. I. (2018). Novel treatments for inflammatory bowel disease. The Korean Journal of Internal Medicine, 33(1), 20–27. http://doi.org/10.3904/kjim.2017.393
Abbvie, Inc. (2018 February 16) AbbVie Announces New Phase 2 Data for Upadacitinib Showing Clinical and Endoscopic Outcomes in Crohn's Disease at 52 Weeks. [Press Relase]. Retrieved from https://news.abbvie.com/news/abbvie-announces-new-phase-2-data-for-upadacitinib-showing-clinical-and-endoscopic-outcomes-in-crohns-disease-at-52-weeks.htm
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

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