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.
SOURCE Eisai Inc.
Type Press Release
Date Released July 08, 2024