Eisai Initiates Phase 2 Clinical Trial to Evaluate Lemborexant in the Treatment of Irregular Sleep-Wake Rhythm Disorder (ISWRD) in Dementia Patients

WOODCLIFF LAKE, N.J. and STAMFORD, Conn., Oct. 31, 2016 /PRNewswire/ -- Eisai Inc. and Purdue Pharma L.P. announced today the initiation of a multi-center, randomized Phase 2 clinical study (Study 202) to evaluate Eisai's internally-discovered oral dual orexin receptor antagonist lemborexant (E2006) in patients with mild to moderate Alzheimer's disease dementia (AD) who suffer from Irregular Sleep-Wake Rhythm Disorder (ISWRD). Lemborexant is being jointly developed by Eisai and Purdue Pharma L.P.

ISWRD, often observed in patients with AD, is a type of circadian rhythm disorder, where there is no clear 24-hour sleep-wake pattern, resulting in sleeping and waking occurring at irregular, inconsistent times during the day and night. There is no known treatment approved for this kind of irregular sleep-wake pattern in patients with various causes of dementia, signifying that this is a condition with high unmet medical need.

"Sleep-wake fragmentation and sleep complaints associated with dementia are serious problems – both for patients and their caregivers," said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "Through research and development on lemborexant, we are striving to potentially fulfill unmet medical needs for this type of sleep disorder."

"We look forward to enrolling patients in these placebo-controlled studies to evaluate the potential clinical benefits of lemborexant in the treatment of ISWRD, which would be an important development for this underserved patient population," said Alan W. Dunton, M.D., Head of Research & Development, Purdue Pharma L.P.

About the Study
Study 202 will evaluate the efficacy and safety of lemborexant in 125 patients aged 65 to 90 with ISWRD and mild to moderate AD. Patients will be randomized to receive 2.5, 5, 10 or 15 mg of lemborexant or placebo orally once daily for four weeks. Over the four weeks of treatment with lemborexant compared to placebo, the primary endpoint will be the dose response of the change from baseline in actigraphy-based sleep efficiency and wake efficiency during the last seven nights of treatment. These changes will be measured using actigraphy, a non-invasive device worn on the wrist that is used to assess sleep-wake patterns continuously for many days. Patients and investigators interested in participating in this trial should contact Eisai Medical Information at 1-888-274-2378.

About Lemborexant
Discovered by Eisai, lemborexant is a dual orexin receptor antagonist which competitively binds to the two subtypes of orexin receptors. The orexin system is a major regulator of the sleep-wake system.

In addition to this Phase 2 study, Eisai and Purdue Pharma L.P. initiated a Phase 3 Study in May 2016 (Study 304) in patients with insomnia disorder to determine the efficacy and safety of lemborexant in 950 patients 55 and older with insomnia disorder.

This release discusses an investigational use of an agent in development and is not intended to convey conclusions about efficacy and safety. There is no guarantee that this investigational agent will successfully complete clinical development or gain FDA approval.

Purdue Pharma is a privately-held pharmaceutical company and is part of a global network of independent associated companies that is known for pioneering research in chronic pain and opioids with abuse deterrent properties. The company's leadership and employees are committed to providing healthcare professionals, patients and caregivers quality products and educational resources to support their proper use. Purdue Pharma is engaged in the research, development, production and distribution of both prescription and over-the-counter medicines and hospital products. With Purdue Pharma's expertise in drug development, commercialization and life-cycle management, the company is diversifying in high-need areas to expand through strategic acquisitions and creative partnerships. For more information, please visit www.purduepharma.com.

At Eisai Inc., human health care (hhc) is our goal. We give our first thought to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.

Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US.

Contacts: Eisai Inc.
Media Inquiries  
Laurie Landau   

Investor Inquiries
Ivor Macleod

Contact: Purdue Pharma L.P. 
Catherine London



SOURCE Eisai Inc.

Type Press Release

Date Released October 31, 2016

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