Eisai Inc is set to begin enrolling patients for a clinical trial to test the effectiveness and safety of E2086 for narcolepsy type 1.


Summary: Eisai Inc announced the registration and upcoming enrollment for Study E2086-A001-101, a clinical trial to evaluate the efficacy, safety, and tolerability of E2086, a novel selective orexin-2 receptor agonist, in adult patients with narcolepsy type 1. The trial, which includes a five-period, single-dose crossover design, aims to compare three dose strengths of E2086 with placebo and an active comparator. E2086 is hypothesized to compensate for the loss of orexin in NT1 patients, addressing symptoms like excessive daytime sleepiness and cataplexy.

Key Takeaways:

  • Clinical Trial Launch: Eisai Inc is initiating a clinical trial (Study 101) to test the novel orexin-2 receptor agonist E2086 in patients with narcolepsy type 1, with sites planned in the US and Canada.
  • Study Design: The trial will assess three dose strengths of E2086 in a five-period, single-dose crossover study, using both objective and patient-reported measures of wake promotion to evaluate its efficacy and safety.
  • Potential Breakthrough: E2086 aims to address the deficiency of orexin in NT1 patients, with nonclinical studies showing promising results in increasing wake time and reducing cataplexy-like episodes.

Eisai Inc has announced the registration and upcoming enrollment for a clinical trial to evaluate the efficacy, safety, and tolerability of E2086, a novel selective orexin-2 receptor agonist, in patients with narcolepsy type 1.

The clinical trial, Study E2086-A001-101 (Study 101), is a five-period, single-dose crossover study in adult patients with narcolepsy type 1. Three dose strengths of E2086 will be assessed compared with placebo and an active comparator using objective and patient-reported measures of wake promotion.

In patients with narcolepsy type 1, excessive daytime sleepiness and cataplexy are reported in association with low levels of the neurotransmitter orexin. As a selective orexin-2 receptor agonist, E2086 is hypothesized to compensate for the loss of orexin in patients with narcolepsy type 1. 

In nonclinical studies, E2086 was shown to increase wake time and decrease cataplexy-like episodes in narcolepsy model mice.

E2086’s Potential Impact on Narcolepsy Treatment

“The availability of drugs like E2086 will open a new era in the treatment of narcolepsy and potentially other disorders of hypersomnolence,” says Lynn Kramer, MD, FAAN, chief clinical officer of deep human biology learning at Eisai, in a release. “By addressing the deficiency of orexin with what is in essence a replacement therapy, E2086 will hopefully provide a meaningful impact on the symptoms and the consequences associated with narcolepsy to improve the quality of lives of these patients.”

Eisai Inc is the US pharmaceutical subsidiary of Tokyo-based Eisai Co Ltd. Its US operations include discovery, research, and development; manufacturing; global supply and logistics; and commercial activities.

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