Eisai has announced the launch of a phase II clinical study, Study 202, to investigate a dual-effect orexin receptor antagonist lemborexant developed for awakening rhythm disorder (ISWRD) patients and mild to medium Efficacy and safety of patients with Alzheimer's disease (AD) dementia. Currently, lemborexant is being developed by Eisai in cooperation with Purdue Pharma of the United States.
Awakening Rhythm Disorder (ISWRD) is a circadian rhythm sleep disorder in which healthy individuals are interrupted by sleep and wake patterns within 24 hours. Sleep and awakening can occur at any time of day and night. The disease is common in a population of patients with neurodegenerative diseases, such as Alzheimer's disease (AD).
According to a meeting of pre-research new drugs held by the US Food and Drug Administration (FDA), ISWRD was identified as different from general insomnia. Currently, there are no drugs approved for patients with irregular sleep-wake patterns, which means there is a highly unmet medical need in the field.
The Study 202 study was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of approximately 125 patients with ISWRD and mild to moderate AD who were 65 to 90 years of age and evaluated lemborexant Efficacy and safety. The primary goal of the study was to treat sleep efficiency and arousal efficiency (evaluated by wrist dynamometer) for the last 7 nights of the 4-week period. The wrist dynamometer is a non-invasive device worn on the wrist to assess the circadian rhythm of sleep-wake mode for several weeks.
Currently, Eisai is also investigating the efficacy and safety of lemborexant in the treatment of general insomnia. A phase III clinical study (Study 304) is investigating the efficacy and safety of lemborexant in approximately 950 patients aged 55 years and older (at least 60% of whom are 65 years of age or older). In addition, Eisai is also planning to launch three additional Phase III clinical studies.
Lemborexant is a dual inhibitor of the OX1 and OX2 receptors, which was discovered and developed by Eisai. This compound inhibits orexin by competitively binding two or two isoforms of the orexin receptors (oresin receptor 1 and receptor 2). . In individuals with insomnia, the orexin system that regulates sleep and wakefulness may not function properly. During normal sleep cycles, the activity of the orexin system is inhibited; this reveals that it is possible to interfere with orexinergic neurotransmission through lemborexant, purposefully promoting the initiation and maintenance of sleep.
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