Eisai Inc. announced today that screening for global Study E2086-G000-202 (Study 202) to assess the efficacy, safety and tolerability of E2086, a novel selective orexin-2 receptor, is now registered on ClinicalTrials.gov as NCT07493265. Study sites are also planned for Canada, China, Europe, Japan, and South Korea.
Study 202 is a three-period, dose escalation study in adult patients with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2). Three dose strengths of E2086 per NT1 or NT2 participants will be assessed compared with placebo using objective and patient-reported measures of wake promotion.
Narcolepsy is a sleep disorder resulting from disorganization of the sleep/wakefulness cycle. In patients with NT1, excessive daytime sleepiness and cataplexy (acute episodes of loss of muscle tone) are reported in association with low levels of the neurotransmitter orexin. In patients with NT2, excessive daytime sleepiness occurs, but without reports of cataplexy.
As a selective orexin-2 receptor agonist, E2086 is hypothesized to compensate for the loss of orexin in patients with narcolepsy. In nonclinical studies, E2086 was shown to increase wake time and decrease cataplexy-like episodes in narcolepsy model mice and to prolong wakefulness in wild-type mice.1 In a recently completed proof-of-mechanism study in patients with NT1, compared with placebo and an existing treatment (modafinil), E2086 provided statistically significant and clinically meaningful increases in wake time as assessed by the objective maintenance of wakefulness test and by the patient-reported Karolinska sleepiness scale.
Source: Eisai
