Eisai to Start Enrolling Narcolepsy Patients in Study

July 8, 2024 -- Eisai Inc. has announced the commencement of screening for Study E2086-A001-101 (Study 101), which is now officially registered on ClinicalTrials.gov under the identifier NCT06462404. This study aims to evaluate the efficacy, safety, and tolerability of a novel selective orexin-2 receptor agonist, E2086. Study 101 will also include sites in Canada.

Study 101 is designed as a five-period, single-dose crossover trial specifically targeting adult patients diagnosed with narcolepsy type 1 (NT1). The study will compare three different dose levels of E2086 against a placebo and an active comparator, employing both objective and patient-reported measures to gauge wakefulness promotion.

Narcolepsy is a neurological disorder characterized by an impaired sleep/wake cycle. For individuals with NT1, symptoms such as excessive daytime sleepiness and cataplexy (sudden loss of muscle control) are linked to reduced levels of the neurotransmitter orexin. E2086, being a selective orexin-2 receptor agonist, is theorized to counteract this orexin deficiency in NT1 patients. Previous nonclinical trials demonstrated that E2086 significantly increased wakefulness and reduced cataplexy-like episodes in narcoleptic mice models.

"The introduction of medications like E2086 marks a significant advancement in the treatment of narcolepsy and potentially other hypersomnolence disorders," stated Lynn Kramer, MD, FAAN, Chief Clinical Officer at Deep Human Biology Learning (DHBL), Eisai. "E2086 aims to address orexin deficiency essentially as a replacement therapy, hopefully making a substantial difference in alleviating the symptoms and consequences of narcolepsy, thereby improving patients' quality of life."

E2086 was discovered by Eisai chemists and is an innovative selective orexin-2 receptor agonist. Nonclinical evidence has shown statistically significant improvements in wakefulness and reductions in cataplexy episodes, marking its potential effectiveness.

Eisai Inc., the U.S. pharmaceutical arm of Tokyo-based Eisai Co., Ltd., focuses on enhancing the lives of patients dealing with cancer, Alzheimer's disease, and other neurodegenerative disorders. The company is driven by a human health care (hhc) mission that prioritizes patients and their families, ensuring that their voices guide Eisai’s initiatives. This mission fosters relationships that help identify and address unmet medical needs and healthcare discrepancies, aiming for societal improvement.

Eisai’s U.S. operations span across various domains, including discovery, research and development, manufacturing, global supply logistics, and commercial activities. The company remains committed to its hhc mission by continuously engaging with patients and healthcare communities.

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