Sumitomo Dainippon Pharma and Otsuka Announce a Worldwide Collaboration and License Agreement for Four Psychiatry and Neurology Compounds
Development code (generic name) | Indication (current development stage and geography) | |
---|---|---|
SEP-363856(ulotaront) | Schizophrenia (Phase 3 in the U.S., Phase 2/3 in Japan and China) | |
SEP-4199 | Bipolar I depression (Phase 3 in the U.S., preparing for Phase 3 in Japan) | |
SEP-378614 | To be determined (Phase 1 in the U.S.) | |
SEP-380135 | To be determined (Phase 1 in the U.S.) |
Reference
About ulotaront (SEP-363856)Ulotaront (SEP-363856) is a trace amine-associated receptor 1 (TAAR1) agonist with serotonin 5-HT1A?agonist activity, jointly developed by Sunovion and PsychoGenics Inc, which is a small-molecule oral agent that does not bind to dopamine D2?or serotonin 5-HT2A?receptors. Sunovion discovered ulotaront in collaboration with PsychoGenics using its in vivo phenotypic SmartCube??platform and associated artificial intelligence algorithms. Phase 2 study results supported efficacy in treating both positive and negative symptoms of schizophrenia while demonstrating a side effect profile with notable similarities to placebo in extrapyramidal symptoms, weight gain, lipid and glucose derangements, and prolactin elevation. The full results of the study were published in the?New England Journal of Medicine (NEJM)?in April 2020. The agent is undergoing Phase 3 studies for schizophrenia in the United States and global clinical Phase 2/3 studies in Japan and China, with other indications under consideration. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for ulotaront for the treatment of schizophrenia in May 2019.
About SEP-4199
SEP-4199 is a small-molecule oral agent with a non-racemic ratio of amisulpride enantiomers developed by Sunovion. Sunovion discovered that the pharmacology of amisulpride is enantiomer-specific, and increasing the ratio of R-amisulpride to S-amisulpride increases the potency for serotonin 5-HT7?receptors relative to dopamine D2?receptors. SEP-4199 was designed with an 85:15 ratio of R-amisulpride to S-amisulpride to increase levels of serotonin 5-HT7?activity intended to enhance antidepressant efficacy and produce reduced levels of D2?receptor occupancy appropriate for the treatment of bipolar depression. In September 2021, Sunovion initiated a global clinical Phase 3 study, which is randomized, double-blind, placebo-controlled, parallel-group, fixed-dosed study for the treatment of bipolar I depression in the U.S. Japan will join this global clinical Phase 3 study.
About SEP-378614
SEP-378614, jointly discovered by Sunovion and PsychoGenics, is a small-molecule oral agent that acts on the central nervous system. Sunovion discovered SEP-378614 in collaboration with PsychoGenics using its in vivo phenotypic SmartCube??platform and associated artificial intelligence algorithms. Pre-clinical study results suggest that it may have rapid onset and long-lasting antidepressant-like activity and enhance neuroplasticity. The agent is undergoing Phase 1 studies in the U.S.
About SEP-380135
SEP-380135, jointly developed by Sunovion and PsychoGenics, is a small-molecule oral agent that acts on the central nervous system. Sunovion discovered SEP-380135 in collaboration with PsychoGenics using its in vivo phenotypic SmartCube??platform and associated artificial intelligence algorithms. Pre-clinical study results suggest its efficacy against a number of behavioral and psychological symptoms in dementia, including agitation/aggression, psychomotor hyperactivity, depression, and deficits in social interaction. The agent is undergoing Phase 1 studies in the U.S.
About Neuropsychiatric Disorders Neuropsychiatric disorders are among the most complex and difficult to treat. Disorders of the brain are often associated with significant and often disabling effects on patients, impacting their loved ones and society more broadly. Nearly one in six people worldwide live with a neurological disorder1, approximately 29 million people worldwide are living with bipolar disorder2, and approximately 20 million people worldwide are living with schizophrenia3.Source
1?World Health Organization (WHO) Neurological Disorders: Public Health Challenges 2006. https://www.who.int/mental_health/neurology/neurological_disorders_report_web.pdf. Accessed February 2021.
2?World Health Organization. Global Burden of Disease, 2004 Report. http://www.who.int. Accessed March 29, 2013 (To Access: Health Topics, Global Burden of Disease, The Global Burden of Disease: 2004 Update).
3?World Health Organization. Mental Disorders. https://www.who.int/news-room/fact-sheets/detail/mental-disorders. Accessed April 2021.Information in this news release was current as of the original release date.