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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/10/2020.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/10/2020.
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Our Science

    • Ozanimod (S1P1 and S1P5 Modulator)

    The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated.

     

    Proposed Mechanism of Action

    Ozanimod is an oral, sphingosine-1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). The exact mechanism by which ozanimod exerts its therapeutic action is unknown. Preclinical data showed that ozanimod was able to induce internalization of the S1P1 receptor and decrease circulation of pro-inflammatory lymphocytes in the bloodstream. A reduction in circulating pro-inflammatory lymphocytes may prevent their migration to sites of inflammation. Preclinical data have also demonstrated that ozanimod treatment results in a dose-dependent reduction in key lymphocyte populations that play a role in inflammatory bowel disease (IBD).1 These results may support the hypothesis that S1P1 is a potential new target for IBD treatment.

    Ozanimod Proposed Mechanism of Action

    GI, gastrointestinal; S1P, sphingosine-1-phosphate

    Ozanimod, an S1P1 and S1P5  modulator is hypothesized to prevent migration of lymphocytes from the lymphoid tissue to the gastrointestinal tract1

    Ozanimod by Disease State

    Ozanimod in Crohn's Disease and Ulcerative Colitis

    Phase 3
    Crohn's Disease

    Phase 3
    Ulcerative Colitis

    View Trials Investigating Ozanimod in Crohn's Disease and Ulcerative Colitis
    View Rationale for Clinical Development

    Rationale for Clinical Development

    Inflammatory bowel disease (ulcerative colitis and Crohn’s disease) is characterized by chronic, relapsing inflammation of the gastrointestinal tract.2,3 The sphingosine-1-phosphate (S1P) pathway plays an important role in the chronic inflammation associated with the development of the gastrointestinal symptoms reported in ulcerative colitis and Crohn’s disease.4 Preclinical data showed that ozanimod was able to induce internalization of the S1P1 receptor and decrease circulation of pro-inflammatory lymphocytes in the bloodstream. A reduction in circulating pro-inflammatory lymphocytes may prevent their migration to sites of inflammation.1 Hence, by targeting S1P, inflammation may be reduced.

    View Related Pathways

    S1P in Inflammatory Bowel Disease

    References

    1. Scott FL, et al. Br J Pharmacol. 2016;173:1778-1792. PMID:26990079
    2. Loftus EV, et al. Gastroenterol Clin North Am. 2002;31:1-20. PMID:12122726
    3. Cleveland Clinic. https://my.clevelandclinic.org/departments/digestive/depts/inflammatory-bowel-disorders.
    4. Nielson OH, et al. Trends Mol Med. 2017;23:362-374. PMID:28283249

    The safety and efficacy of the agents and/or uses under investigation have not been established. There is no guarantee that the agents will receive health authority approval or become commercially available in any country for the uses being investigated.

     

    Proposed Mechanism of Action

    Ozanimod is an oral, sphingosine-1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5).1 Because both S1P1 and S1P5 are expressed on multiple cells throughout the body, including the central nervous system (CNS), they represent a target for ozanimod that can potentially lead to clinically relevant neuroprotection.1-4 Ozanimod can modulate S1P1 expression, resulting in the retention of autoreactive T and B cells in lymphoid tissue and decreasing their circulation in the blood stream. A reduction in these types of lymphocytes prevents their migration to sites of inflammation.1,5 Preclinical studies demonstrated a reversible reduction in circulation of B and T lymphocytes in multiple sclerosis (MS) animal models.6

    Ozanimod Propose Mechanism of Action

    CNS, central nervous system; S1P, sphingosine-1-phosphate

    Ozanimod, an S1P1  and S1P5  modulator is hypothesized to prevent S1P-mediated lymphocyte migration from lymphoid organs to the CNS 1, 5, 6

    Ozanimod by Disease State

    Ozanimod in Multiple Sclerosis

    Phase 3
    Relapsing Multiple Sclerosis

    View Trials Investigating Ozanimod in Multiple Sclerosis
    View Rationale for Clinical Development

    Rationale for Clinical Development

    The blood-brain barrier prevents peripheral immune cells from entry into the CNS; however, in MS, the blood-brain barrier is disrupted, allowing infiltration of these cells. Autoreactive T and B cells in the CNS contribute to chronic inflammatory processes that result in myelin and axonal damage7-10 The sphingosine-1-phosphate (S1P) pathway is hypothesized to play an important role in the chronic inflammation associated with MS.11,12 Ozanimod selectively targets S1P1 and S1P5 receptors, which are expressed on multiple cells throughout the CNS.3,4 In MS, ozanimod is thought to retain autoreactive T and B cells in lymphoid tissue, thus preventing their migration into the CNS.1,5 Hence, S1P receptor modulation reduces the number of circulating T and B lymphocytes, and potentially decreases the damage caused by these cells when they infiltrate the blood-brain barrier.

    View Related Pathways

    S1P in Multiple Sclerosis

    References

    1. Scott FL, et al. Br J Pharmacol.2016;173:1778-1792. PMID:26990079
    2. Rosen H, et al. Ann Rev Biochem. 2009;78:743-768. PMID:19231986
    3. Groves A, et al. J Neurol Sci. 2013;328:9-18. PMID:23518370
    4. O’Sullivan S, et al. Neuropharmacology. 2017;113:597-607. PMID:27825807
    5. Pham TH, et al. Immunity. 2008;28:122-133. PMID:18164221
    6. Nielson OH, et al. Trends Mol Med. 2017;23:362-374. PMID:28283249
    7. Prinz M, Priller J. Nat Neurosci. 2017;20:136-144. PMID: 28092660
    8. Tuosto L. Austin J Mult Scler Neuroimmunol. 2015;2:1009-1018.
    9. Shlomchik MJ. Immunity. 2008;28:18-28. PMID:18199415
    10. Fraussen J, et al. Autoimmun Rev. 2016;15:896-899. PMID:27396817
    11. Brinkmann V. Br J Pharmacol. 2009; 158:1173-1182. PMID:19814729
    12. Kulakowska A, et al. Neurosci Lett. 2010;477:149-152. PMID:2043523