NUTLEY,
N.J., July 8, 2024 /PRNewswire/ -- Eisai
Inc. announced today that screening for Study E2086-A001-101 (Study
101) to assess the efficacy, safety and tolerability of E2086, a
novel selective orexin-2 receptor, is now registered on
ClinicalTrials.gov as NCT06462404. Study sites are also planned for
Canada.
Study 101 is a five-period, single-dose crossover study in adult
patients with narcolepsy type 1 (NT1). Three dose strengths of
E2086 will be assessed compared with placebo and an active
comparator using objective and patient-reported measures of wake
promotion.
Narcolepsy is a sleep disorder resulting from disorganization of
the sleep/wakefulness cycle. In patients with NT1, excessive
daytime sleepiness and cataplexy (acute episodes of loss of muscle
tone) are reported in association with low levels of the
neurotransmitter orexin. As a selective orexin-2 receptor agonist,
E2086 is hypothesized to compensate for the loss of orexin in
patients with NT1. In nonclinical studies, E2086 was shown to
increase wake time and decrease cataplexy-like episodes in
narcolepsy model mice.1
"The availability of drugs like E2086 will open a new era in the
treatment of narcolepsy and potentially other disorders of
hypersomnolence," said Lynn Kramer,
MD, FAAN, Chief Clinical Officer, Deep Human Biology Learning
(DHBL), Eisai. "By addressing the deficiency of orexin with what is
in essence a replacement therapy, E2086 will hopefully provide a
meaningful impact on the symptoms and the consequences associated
with narcolepsy to improve the quality of lives of these
patients."
For information about this study, please contact Eisai Medical
Information at https://www.eisaimedicalinformation.com/ or
1-888-274-2378 (Monday through Friday 8:30
AM – 5:00 PM EST, excluding
holidays).
MEDIA CONTACT
Libby Holman
Eisai Inc.
+ 1-201-753-1945
Libby_Holman@eisai.com
About E2086
Discovered by Eisai chemists, E2086 is a
novel selective orexin-2 agonist. Nonclinical studies have
demonstrated statistically significant increases in time spent
awake and significant reductions in rates of cataplexy.
About Eisai Inc.
Eisai Inc. is a human health
care (hhc) company dedicated to improving the lives of
people affected by cancer, Alzheimer's disease and other
neurodegenerative conditions. Everything we do is guided by the
simple principle that patients and their families come first, and
we have a responsibility to listen to and learn from them.
Our hhc mission is the shared purpose that connects us to
those we serve. It creates a network of powerful relationships that
enable us to identify, understand and address unmet needs and
healthcare disparities as we work towards achieving societal
good.
Eisai Inc. is the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd. Our U.S.
operations include discovery, research and development;
manufacturing; global supply and logistics; and commercial
activities.
To learn more, please visit us
at https://us.eisai.com and connect with us
on X and LinkedIn. For more information on our
research, follow our dedicated neurology (LinkedIn and X) and
oncology (LinkedIn and X) pages.
1 Hatanaka K, et al. Discovery of a Novel Orally
Available Selective Orexin 2 receptor Agonist, E2086, as a
Therapeutic Drug for Narcolepsy and Other Hypersomnia Disorders.
Presented at the World Sleep Congress, Rome, Italy, 11-16
March 2022.
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SOURCE Eisai Inc.