- Eisai (OTCPK:ESALF)(OTCPK:ESALY) announces two new clinical trials assessing pipeline candidates in Alzheimer's disease (AD).
- A Phase 2, Study 202, has been initiated that will evaluate E2006 (lemborexant) in patients with mild-to-moderate AD dementia who suffer from Irregular Sleep-Wake Rhythm Disorder (ISWRD). Patients will be randomized to receive either a once daily 2.5 mg, 5 mg, 10 mg or 15 mg dose of lemborexant or placebo for four weeks. The primary endpoint is the change from baseline in actigraphy-based sleep efficiency and wake efficiency during the last seven nights of treatment. An actigraph is a small sensor worn on the body to monitor rest/activity cycles.
- Lemborexant, being jointly developed with Purdue Pharma, is a dual orexin receptor antagonist that binds to the two subtypes of orexin receptors. Orexin is a major regulator of the sleep-wake system.
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Enrollment is underway in a Phase 3 program assessing E2609 for the treatment of early AD. The first trial, MISSIONAD1, is a double-blind, placebo-controlled, parallel group study in 1,330 subjects. The treatment group will receive a daily 50 mg dose of E2609 for 24 months. The primary endpoint will be based on the Clinical Dementia Rating Sum of Boxes (CDR-SB).
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E2609, being jointly developed with Biogen (BIIB -0.7%), inhibits an enzyme called BACE which plays a key role in the production of amyloid beta peptides. Inhibiting BACE may decrease the formation of amyloid plaques in the brain thereby slowing the progression of AD.