Eisai is starting recruitment for aPhase I trial evaluating E2086, a novel selective orexin-2 receptor, in patients with narcolepsy type 1.
Narcolepsy is a rare long-term brain condition that can prevent a person from choosing when to wake or sleep. It is characterised by excessive daytime sleepiness. Type 1 narcolepsy accounts for 20% of total narcolepsy cases and is characterised by the presence of cataplexy, a sudden loss of muscle tone while a person is awake.
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The double-blind, placebo-controlled Phase I trial (NCT06462404) is expected to enrol approximately 40 adult patients with narcolepsy type 1. The study will assess three dose strengths of E2086 in a five-period, single-dose crossover study, using objective and patient-reported wake promotion measures to evaluate its efficacy and safety.
The study’s primary endpoints include mean sleep latency, defined as the amount of time a person takes to fall asleep, measured using the maintenance of wakefulness test (MWT). The mean sleep latency will be measured at five different time points – days one, five, nine, 13 and 17.
E2086 is a selective orexin-2 receptor agonist, potentially compensating for orexin loss. High levels of orexin are associated with wakefulness and suppress rapid eye movement (REM) sleep.
GlobalData epidemiologists estimate that there were more than 900,000 diagnosed prevalent cases of narcolepsy in 2023 and over 930,000 diagnosed prevalent cases in 2027. There are a limited number of approved therapies for narcolepsy, with four companies developing products in Phase III.
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By GlobalDataGlobalData is the parent company of Clinical Trials Arena.
NLS Pharmaceutics is evaluating Quilience (extended-release mazindol) in two Phase III trials, NLS-1031 and NLS-1032, as a treatment for narcolepsy type 1. Both studies measured weekly cataplexy episodes as the primary endpoint over eight weeks of treatment.
In July 2023, Takeda’s orexin receptor 2 agonist, TAK-994, met the primary endpoints in a Phase II trial. The therapy improved sleep latency on MWT by 23.9, 27.4, and 32.6 minutes for three doses of TAK-994, compared to -2.5 minutes in the placebo group. The therapy also reduced the weekly cataplexy rate compared to placebo.
