Eisai Co., Ltd. announced that the latest data on its oral dual orexin receptor antagonist lemborexant and its oral beta secretase cleaving enzyme (BACE) inhibitor elenbecestat(1) will be presented at the 10th Clinical Trials on Alzheimer’s Disease (CTAD), taking place in Boston, the United States, from November 1 to 4.
At the CTAD meeting, there will be a poster presentation on the characteristics of sleep and wakefulness measured by actigraphy(2) in patients with Irregular Sleep-Wake Rhythm Disorder (ISWRD) and Alzheimer’s disease (AD) dementia. This is the first clinical study of lemborexant to assess the circadian rhythm of sleep-wake patterns in this patient population. ISWRD is a type of circadian rhythm sleep disorder where the pattern of sleep and wakefulness that repeats itself over a 24-hour period in healthy individuals is broken down, and sleeping and waking occur instead at various times during the day and night.
It is a common comorbid condition in AD, appears early in the course of disease, and is associated with many of the behavioral disturbances in AD patients such as agitation, restlessness and wandering. For elenbecestat, there are two poster presentations scheduled, including a presentation on the use of the International Shopping List Test as the objective assessment of cognitive impairment to identify subjects with early Alzheimer’s disease in the phase 3 clinical trials.
Lemborexant, a dual orexin receptor antagonist, is an in-house discovered novel small molecule which inhibits orexin by binding competitively to two subtypes of orexin receptors (orexin receptor 1 and 2). Lemborexant is being jointly developed by Eisai and Purdue Pharma L.P. Elenbecestat, its in-house discovered BACE inhibitor, is being jointly developed by Eisai and Biogen Inc. Two global Phase 3 clinical studies (known as MISSIONAD1 and MISSIONAD2) are ongoing in patients with early AD. In addition, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of elenbecestat, a process allowing priority reviews by the FDA for drugs deemed as having potential to treat serious conditions and tackle key unmet medical needs.
Furthermore, there will be several oral presentations for anti-A beta antibody aducanumab. Eisai has exercised its option to jointly develop and commercialize aducanumab with Biogen.
Eisai considers dementia a therapeutic area of focus and is committed to new drug development in this field. Eisai strives to bring promising therapies to patients worldwide as early as possible.
(1) The generic name is not yet fixed at this time.
(2) Actigraphy is a non-invasive method for measuring and assessing the circadian rhythm of sleep-wake patterns continuously over several weeks through a device worn on the wrist.
About Eisai
Eisai Co., Ltd. is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com
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