— SEP-363856 offers an innovative approach to the treatment of
schizophrenia including the potential to be the first agent for the
treatment of schizophrenia that does not bind to dopamine 2 (D2)
receptors —
— Schizophrenia affects more than 2 million people in the United
States —
MARLBOROUGH, Mass. & PARAMUS, N.J.–(BUSINESS WIRE)–Sunovion
Pharmaceuticals Inc. (Sunovion) and PsychoGenics
Inc. (PsychoGenics), today announced that the U.S. Food and Drug
Administration (FDA) has granted Breakthrough Therapy Designation for
SEP-363856, a novel agent for the treatment of people with schizophrenia.
Breakthrough Therapy Designation is intended to expedite the development
and review of drugs for serious or life-threatening conditions when
preliminary clinical evidence indicates that the drug may demonstrate
substantial improvement over available therapy on one or more clinically
significant endpoints.1
“Schizophrenia is a major public health challenge associated with
persistent abnormalities in thinking, perception and behavior, as well
as impairments in quality of life and functional skills, that affects
approximately 2.4 million people in the U.S.,”2 said Antony
Loebel, M.D., President and Chief Executive Officer at Sunovion.
“Breakthrough Therapy Designation underscores the potential of
SEP-363856 as a novel treatment for patients with schizophrenia, for
whom few major advances in treatment have occurred since the advent of
antipsychotic pharmacotherapy in the 1950s. Investigational studies to
further evaluate the clinical benefit of SEP-363856 are in progress, and
we look forward to working closely with the FDA on this important
potential new therapy.”
SEP-363856 does not bind to dopamine 2 (D2) or serotonin 2A (5-HT2A)
receptors, which are thought to mediate the effects of currently
available antipsychotic medicines. Although the exact mechanism of
action is unknown, SEP-363856 is believed to activate TAAR1 (trace
amine-associated receptor 1) in addition to 5-HT1A (serotonin 1A)
receptors.
The FDA granted Breakthrough Therapy Designation for SEP-363856 based on
pivotal, Phase 2 data from Study SEP361-201, which were presented by
Sunovion at the 57th Annual Meeting of the American College
of Neuropsychopharmacology (ACNP) in December 2018, as well as data from
Study SEP361-202, a six-month, open-label, safety and tolerability
extension study.
With this Breakthrough Therapy Designation SEP-363856 is eligible for
intensive guidance from the FDA on the drug development program and
priority review.1
About SEP 361-201
SEP 361-201, a randomized, placebo-controlled, double-blind,
registration study, met its primary endpoint, demonstrating that
hospitalized patients with acute exacerbation (worsening) of
schizophrenia treated with SEP-363856 showed statistically significant
and clinically meaningful improvement in the Positive and Negative
Syndrome Scale (PANSS) total score compared to placebo after four weeks
of treatment (-17.2 vs. -9.7, respectively; p=0.001). Patients treated
with SEP-363856 also showed improvement in the overall severity of
illness as assessed by the Clinical Global Impression Scale – Severity
(CGI-S) (p<0.001). In addition, improvement was found in all major PANSS
(positive, negative and general psychopathology) subscales (p<0.02).
SEP-363856 was found to be generally well tolerated with notable
similarities to placebo treatment in discontinuation rates; proportion
of patients experiencing extrapyramidal symptoms or akathisia
(restlessness); and change in metabolic parameters such as weight,
lipids, glucose and prolactin.
About SEP-363856
SEP-363856 is a psychotropic agent with a novel, non-D2 mechanism of
action, distinct from currently marketed antipsychotics. Sunovion
discovered SEP-363856 in collaboration with PsychoGenics based in part
on a mechanism-independent approach using the in vivo phenotypic
SmartCube® platform and associated artificial intelligence
algorithms. SEP-363856 was optimized for antipsychotic activity by
Sunovion medicinal chemists based on quantitative structure-activity
relationship analysis, in collaboration with PsychoGenics. SEP-363856 is
jointly owned by Sunovion and PsychoGenics. Sunovion has exclusive
rights to develop and commercialize SEP-363856 globally.
SEP-363856 is being studied in a global development program for
schizophrenia as well as for Parkinson’s disease psychosis, with
additional indications under consideration. Clinical trial results to
date demonstrate a predictable pharmacokinetic (PK) profile suitable for
once daily use.
About Schizophrenia
Schizophrenia is a chronic, serious and often severely disabling brain
disorder that affects more than 23 million people worldwide2
and approximately one in 100 adults (about 2.4 million people) in the
United States.3 It is characterized by positive symptoms,
such as hallucinations, delusions and disorganized thinking as well as
negative symptoms, such as lack of emotion, social withdrawal, lack of
spontaneity and cognitive impairment that includes problems with memory,
attention and the ability to plan, organize and make decisions.3
About Sunovion Pharmaceuticals Inc. (Sunovion)
Sunovion is a global biopharmaceutical company focused on the innovative
application of science and medicine to help people with serious medical
conditions. Sunovion’s vision is to lead the way to a healthier world.
The company’s spirit of innovation is driven by the conviction that
scientific excellence paired with meaningful advocacy and relevant
education can improve lives. With patients at the center of everything
it does, Sunovion has charted new paths to life-transforming treatments
that reflect ongoing investments in research and development and an
unwavering commitment to support people with psychiatric, neurological
and respiratory conditions.
Headquartered in Marlborough, Mass., Sunovion is an indirect,
wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion
Pharmaceuticals Europe Ltd., based in London, England, and Sunovion
Pharmaceuticals Canada Inc., based in Mississauga, Ontario, are
wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc.
Additional information can be found on the company’s websites: www.sunovion.com,
www.sunovion.eu
and www.sunovion.ca.
Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.
About PGI Drug Discovery LLC and PsychoGenics Inc. (collectively
PsychoGenics)
PsychoGenics Inc. and its discovery arm PGI Drug Discovery LLC
(collectively known as PsychoGenics) have pioneered the translation of
rodent behavioral and physiological responses into robust,
high-throughput and high-content phenotyping. PsychoGenics’ drug
discovery platforms, SmartCube®, NeuroCube® and
PhenoCube®, have been used in shared-risk partnerships with
major pharmaceutical companies, resulting in the discovery of several
novel compounds now in clinical trials or advanced preclinical
development.
PsychoGenics’ capabilities also include standard behavioral testing,
electrophysiology, translational electroencephalogram (EEG), molecular
biology, microdialysis and quantitative immunohistochemistry. In
addition, the company offers a variety of in-licensed transgenic mouse
models that support research in areas such as Huntington’s disease,
autism spectrum disorders, psychosis/schizophrenia, depression/
post-traumatic stress disorder (PTSD), Alzheimer’s disease, Parkinson’s
disease, muscular dystrophy, amyotrophic lateral sclerosis (ALS) and
seizure disorders. For more information on PsychoGenics Inc., visit www.psychogenics.com.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical
companies in Japan, operating globally in major pharmaceutical markets,
including Japan, the U.S., China and the European Union. Sumitomo
Dainippon Pharma aims to create innovative pharmaceutical products in
the Psychiatry & Neurology area, the Oncology area and Regenerative
medicine/Cell therapy field, which have been designated as the focus
therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in
2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo
Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than
6,000 employees worldwide. Additional information about Sumitomo
Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.
SUNOVION is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon
Pharma Co., Ltd.
© 2019 Sunovion Pharmaceuticals Inc. All rights reserved.
For a copy of this release, visit Sunovion’s web site at www.sunovion.com
References
1 U.S. Food and Drug Administration. Breakthrough Therapy.
[Internet]. Available from: https://www.fda.gov/ForPatients/Approvals/Fast/ucm405397.htm.
Accessed February 2019.
2 Regier DA, Narrow WE, Rae DS,
Mandercheid RW, Locke B2, Goodwin, FK. The de Facto US Mental and
Addictive Disorders Service System. Arch Gen Psychiatry. 1993;50:85-94.
Calculated by extrapolating from the 2008 United States Census Bureau
population estimates.
3 National Institute of Mental
Health. Schizophrenia. [Internet]. Available from: https://www.nimh.nih.gov/health/topics/schizophrenia/index.shtml.
Accessed September 2018.
Contacts
Kirsten Fallon
Senior Manager, Portfolio Communications
Sunovion
Pharmaceuticals Inc.
774-369-7116
[email protected]
Emer Leahy, Ph.D.
PsychoGenics, Inc.
914-406-8008
[email protected]
