New Treatment for IBD in Clinical Trials: Ozanimod
New IBD Medication Designed to Block Sources of Inflammation
What is Ozanimod ?
Ozanimod is one of the latest drugs being developed to treat autoimmune conditions. It 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.
The new drug is not just for IBD. In fact, Ozanimod has already entered into phase III clinical trials for treating multiple sclerosis (MS) by slowing brain atrophy. It is expected to hit the market in late 2018 for the treatment of MS, after FDA approval.
Ozanimod molecular structure ball and stick model. Wikimedia commons.
What does Ozanimod do?
Technically speaking, Ozanimod is a sphingosine 1-phosphate 1 (S1PR1) receptor antagonist. S1PR1 is a protein involved in regulating endothelial cells and immune response modulation.
You may already be familiar with the names of a few receptor antagonists available as IBD treatment options. Like Ozanimod , Vedolizumab and Natalizumab are also receptor antagonists. While they target different mechanisms and receptors, all of these drugs work to dampen a biologic response by blocking a receptor rather than activating it. By inhibiting the S1PR1 receptor, Ozanimod modulates the body’s immune response by decreasing the number of lymphocytes in the gastrointestinal tract.
Studies on Ozanimod for IBD
Many of the studies on Ozanimod and IBD to date have been conducted on animals, but so far, the evidence looks promising. Researchers have concluded that Ozanimod is well tolerated and is a promising treatment for chronic inflammatory diseases.
Furthermore, Ozanimod showed robust efficacy in suppressing inflammatory cytokines and reducing lymphocytes when compared to anti-TNF therapy (Humira, Simponi, Cimzia, Remicade).
The first phase II study for ulcerative colitis, (the TOUCHSTONE study), evaluated Ozanimod in 197 patients with moderate to severe ulcerative colitis. At 8 months, remission rates were 21% and 26% in patients taking 1 and 0.5 mg of Ozanimod , respectively, with only 6% of patients entering remission in in the placebo group.
What is Ozanimod's Current Status?
Ozanimod is currently in different clinical phases depending on the condition that it treats.
Phase III trials are already underway to evaluate Ozanimod for ulcerative colitis. This means that clinical researchers and physicians are testing the drug on patients with UC to assess its efficacy, safety, and dosing. Already having shown that the drug is safe and has an effect, the ultimate goal in phase III trials is to evaluate drug’s therapeutic effect (on anywhere between 300 and 3,000 patients) before making it available on the market.
In late 2017, Celgene released phase II clinical trial data on studies that examined Ozanimod for Crohn’s Disease, and they just began phase III trials in early 2018. Moving forward, Celgene will continue to test for other potential autoimmune uses (including dermatological and rheumatological conditions).
Does Ozanimod Treat Crohn’s Disease?
Yes—Ozanimod has just entered into phase III clinical trials for Crohn’s Disease.
Does Ozanimod Treat Ulcerative Colitis?
Yes—currently, Ozanimod is being tested in phase III clinical trials for ulcerative colitis.
How Can I Learn More About Ozanimod ?
(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