The dose escalation study will evaluate the efficacy, safety, and tolerability of a novel selective orexin-2 receptor agonist in adults with narcolepsy type 1 and type 2.
Key takeaways:
- Eisai’s Study 202 is now registered on clinicaltrials.gov and will assess three dose strengths of E2086 compared with a placebo.
- The trial involves adult patients with narcolepsy type 1 or type 2, utilizing both objective and patient-reported measures of wake promotion.
- Previous proof-of-mechanism data showed E2086 increased wake time in patients with narcolepsy type 1 compared to a placebo and modafinil.
Eisai Inc announced that screening is underway for a global phase 2 study to assess the efficacy, safety, and tolerability of E2086, a novel selective orexin-2 receptor agonist, in patients with narcolepsy.
The trial, officially named Study E2086-G000-202 (Study 202) and registered on clinicaltrials.gov, is a three-period, dose escalation study. It will enroll adult patients diagnosed with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2).
Researchers will evaluate three dose strengths of E2086 per NT1 or NT2 participant. The outcomes will be compared against a placebo using both objective and patient-reported measures of wake promotion. Study sites are planned for Canada, China, Europe, Japan, and South Korea.
As a selective orexin-2 receptor agonist, E2086 is hypothesized to compensate for the loss of orexin in patients with narcolepsy.
According to the company, nonclinical studies of E2086 demonstrated increased wake time and decreased cataplexy-like episodes in narcolepsy mouse models, as well as prolonged wakefulness in wild-type mice. Additionally, a recently completed proof-of-mechanism study in patients with NT1 showed that E2086 provided statistically significant and clinically meaningful increases in wake time compared to both a placebo and an existing treatment, modafinil.
These previous results were assessed using the objective maintenance of wakefulness test and the patient-reported Karolinska sleepiness scale.
