Date: 2016-10-28
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Eisai (Japan)
Product: lemborexant (E2006)
Action
mechanism: orexin receptor antagonist. Lemborexant (E2006) is a dual orexin receptor antagonist. This Eisai in-house discovered and developed small molecule inhibits orexin by binding competitively to two subtypes of orexin receptors (orexin receptor 1 and 2). In individuals with insomnia, it is possible that the orexin system, which regulates sleep and wakefulness, is not functioning normally. During normal periods of sleep, orexin system activity is suppressed, suggesting it is possible to purposefully counteract inappropriate wakefulness and facilitate the initiation and maintenance of sleep by interfering with orexin neurotransmission. Lemborexant is being jointly developed by Eisai and Purdue Pharma. Regarding the development of lemborexant, a Phase III clinical study (Study 304) in patients with general insomnia is also in progress. Study 304 is a Phase III clinical study evaluating the efficacy and safety of lemborexant in approximately 950 participants, 55 years or older (at least 60% aged 65 years or older) with insomnia disorder. In addition to Study 304, three other Phase III studies are being planned.
Disease: patients with Irregular Sleep-Wake Rhythm Disorder and mild to moderate Alzheimer’s disease dementia
Therapeutic area: Neurodegenerative diseases - Neurological diseases
Country:
Trial
details: Study 202 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of lemborexant in approximately 125 patients aged 65 to 90 with Irregular Sleep-Wake Rhythm Disorder (ISWRD) and mild to moderate Alzheimer’s disease (AD) dementia. The primary objective will be to evaluate the sleep efficiency and wake efficiency during the last seven nights of 4 weeks of treatment with lemborexant compared to placebo as measured using actigraphy. An actigraph is a non-invasive device worn on the wrist, and is used for assessing the circadian rhythm of sleep-wake patterns continuously over several weeks.
Latest
news: * On October 28, 2016, Eisai announced the initiation of a Phase II clinical study of its internally-discovered oral dual orexin receptor antagonist lemborexant (E2006) in patients with Irregular Sleep-Wake Rhythm Disorder (ISWRD) and mild to moderate Alzheimer’s disease (AD) dementia. At the pre-investigational new drug meeting held with the FDA, it was confirmed ISWRD is different from general insomnia. There is no
known treatment approved for an irregular sleep-wake pattern in patients, meaning this is a condition with
high unmet medical need.
