Session1-1 Drug Discovery of Oxytocin related Autism Spectrum Disorder

Yuji Kogami　~SkySea Pharmaceutical Inc.~

[Summary]

In most 1% of ASD patient of people around the world.
However, oxytocin itself doesn't work well for ASD because it's endogenous hormone and easy to metabolize. So then the oxytocin derivatives will be required long-lasting agonistic activities. Finally SkySea Pharmaceutical Inc. obtained long-lasting oxytocin derivatives SSP-16-46601 and SSP-16-46603 in good in vitro profile of the agonistic activity and good selectivity for the vasopressin receptors, V1a, V1b and V2.
ASD including studies in turn a good vivo studies and good DMPK profile. But actually it is more important how to enter clinical studies because ASD is a quite heterogeneous disorder including Asperger's syndrome or Rett's syndrome, or fragile X syndrome and so on. So then we should design oxytocin related ASD for recruiting in the clinical studies.
Oxytocin related ASD patients needed to find the oxytocin level in saliva before entering clinical trials by using anti-oxytocin monoclonal antibody. After that, recruiting the oxytocin related ASD patient to enters in a clinical study. In recently, we obtained an oxytocin monoclonal antibody and then presented WCNH 2019 in Israel in this April. Our anti-oxytocin monoclonal antibody is a good useful tool for staining oxytocin neurons in mice and rats. In our schedule, by the end of this year we would like to enter the preclinical study and after that IND and phase I clinical trial in 2021.
After getting oxytocin measurement kit, to recruit phase II patients in 2022.
In 2023 getting POC in phase II trial we would like to license out to pharmaceutical companies.
This is a member only 3 people. Me, Yumi Watanabe, and financial support from Ikkei Matsuda and scientific advisor from Hokkaido University Shuto and Higashida from Kanazawa University. So, thank you so much.

[Profile]

2006 AsahiKasei Pharmaceutical 2006-2010 PRISM BioLab Corporation Director 2010- D.D.P. Corporation, CEO & President 2015- SkySea Pharmaceutical Inc., CEO & President