EA Pharma Co., Ltd.
National Center of Neurology and Psychiatry

EA Pharma Co., Ltd. (President, Yuji Matsue; Headquarters, Tokyo, Japan) (hereinafter “EA Pharma”) and National Center of Neurology and Psychiatry (President, Hidehiro Mizusawa; Headquarters, Tokyo, Japan) (hereinafter “NCNP”) have signed a worldwide exclusive license agreement for development, manufacture and marketing for all indications of OCH-NCNP1, which is under development by NCNP (hereinafter “OCH”).

Under the above agreement, EA Pharma pays an initial fee, milestone fees and royalties to NCNP.

OCH was designed and synthesized by Dr. Takashi Yamamura (Director, Department of Immunology, National Institute of Neuroscience, NCNP) and his colleague by modifying the structure of glycolipid alpha-galactosylceramide (alpha-GalCer) produced by bacteria parasitizing marine sponge.¹⁾ In recent years, it was found that human enteric bacteria produce analogues of alpha-GalCer, similar to OCH. Such gut bacteria-derived glycolipids are thought to contribute to immune homeostasis by inducing Th1 and Th2 cytokines from natural killer T cells (NKT).^{2), 3)} Although alpha-GalCer induces both Th1 and Th2 cytokines from NKT cells, OCH selectively induces production of Th2 cytokines. Therefore, OCH has the therapeutic potentials to suppress the activity of Th1 cytokines and to improve chronic inflammation caused by excessive actions of Th1 cytokines. NCNP has conducted an investigator-initiated PI trial for OCH with patients suffering from multiple sclerosis and now plans to proceed to PIIa. Keio University Hospital has been conducting jointly with NCNP an investigator-initiated PI/II clinical trial for OCH with patients with Crohn’s disease since 2016.⁴⁾

The above agreement was realized through the opportunity of introduction of OCH to EA Pharma by Translational Research Center for Medical Innovation (TRI)^* of Foundation for Biomedical Research and Innovation at Kobe, which supports development of research seeds in universities and other research institutes of Japan. EA Pharma and NCNP collaborate to promote development of OCH to contribute to treatment and increase of QOL of patients with intractable diseases.

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1) Miyamoto K, Miyake S, Yamamura T., A synthetic glycolipid prevents autoimmune encephalomyelitis by inducing TH2 bias of natural killer T cells. Nature. 2001; 413: 531-534.
2) An D et al., Sphingolipids from a symbiotic microbe regulate homeostasis of host intestinal natural killer T cells. Cell. 2014; 156: 123-133.
3) Wieland Brown LC et al., Production of -α-galactosylceramide by a prominent member of the human gut microbiota. PLoS Biol. 2013; 11: e1001610.
4) Keio University and AMED initiate an investigator-initiated clinical trial to investigate the safety and efficacy of an investigational drug for treatment of intractable Crohn’s disease (Press release in Japanese only)
https://www.keio.ac.jp/ja/press-releases/2016/9/15/28-18435/

* Translational Research Center for Medical Innovation (TRI): https://advances.tri-kobe.org/

The development of OCH-NCNP1 is supported by the following grants.

• Ministry of Health, Labour and Welfare (Japan) Research Grants.
• Japan Agency for Medical Research and Development (AMED) Research Grants.