Eisai Initiates Phase II Study of Dual Orexin Receptor Antagonist Lemborexant in People with Irregular Sleep-Wake Rhythm Disorder (ISWRD) and Dementia

HATFIELD, England, November 8, 2016 /PRNewswire/ --

FOR UK MEDIA ONLY: NOT FOR AUSTRIAN/SWISS JOURNALISTS 

Eisai today announces the initiation of a multicentre, randomised phase II clinical study of lemborexant (development code: E2006) in people with Irregular Sleep-Wake Rhythm Disorder (ISWRD) and mild to moderate Alzheimer's disease. Lemborexant is an oral dual orexin receptor antagonist discovered by Eisai and developed by Eisai and Purdue Pharma L.P.

ISWRD is a type of circadian rhythm sleep disorder characterised by an irregular sleep-wake pattern.^[1] Daytime is often composed of multiple naps, whereas nighttime sleep is severely fragmented and shortened.^[1]

Study 202 is a multicentre, randomised, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of lemborexant in 125 participants aged 65 to 90 with ISWRD and mild to moderate Alzheimer's disease. The primary objective will be to evaluate the sleep efficiency and wake efficiency during the last four weeks of treatment with lemborexant compared to placebo, measured by actigraphy. An actigraph is a non-invasive device worn on the wrist to assess the circadian rhythm of sleep-wake patterns over several weeks.

A phase III clinical study of lemborexant is also underway in insomnia. Study 304 (ClinicalTrials.gov Identifier: NCT02783729) is a phase III clinical study to evaluate the efficacy and safety of lemborexant in approximately 950 participants, 55 years or older with insomnia disorder.^[2] The primary endpoint of the study is change from baseline in mean wake after sleep onset in the second half of the night (WASO2H) compared with zolpidem tartrate.^[3] In addition to study 304, three other phase III studies are planned.

Lemborexant is a dual orexin receptor antagonist, which competitively binds to two subtypes of orexin receptors (orexin receptor 1 and 2).^[3] The orexin system is a major regulator of the sleep-wake cycle and orexin receptor antagonists have the potential to counteract inappropriately timed nighttime wakefulness and to promote a regular sleep-wake cycle.^[4]

"We are aiming to develop lemborexant as a first-in-class medicine for ISWRD to improve sleep and wake patterns for patients with dementia, and as a best-in-class medicine for insomnia disorder. We are striving to deliver lemborexant and contribute to increasing the benefit to patients around the world as soon as possible," comments Dr. Lynn Kramer, Chief Clinical Officer and Chief Medical Officer of Eisai's Neurology Business Group.

The continued development of its neurology portfolio underscores Eisai's human health care (hhc) mission, the company's commitment to innovative solutions in disease prevention, cure and care for the health and wellbeing of people worldwide. Eisai is committed to the therapeutic area of neurology and the unmet medical needs of people with sleep disorders and their families.

About Study 202 

Study 202 is a multicentre, randomised, double-blind, placebo-controlled, parallel-group phase II clinical study of the efficacy and safety of lemborexant in subjects with ISWRD and mild to moderate Alzheimer's disease dementia. Patients with ISWRD associated with Alzheimer's disease will be administered lemborexant or placebo for 4 weeks to determine whether at least one dose of lemborexant is superior to placebo on the change from baseline of actigraphy mean sleep efficiency and actigraphy wake efficiency during the last week of 4 weeks of treatment.

About Study 304^[3] (ClinicalTrials.gov Identifier: NCT02783729)

Study 304 is a multicentre, randomised, double-blind, placebo-controlled, active comparator, parallel-group phase III clinical study of the efficacy and safety of lemborexant in approximately 950 participants 55 years and older (at least 60% aged 65 years or older) with insomnia disorder.

About Lemborexant 

Lemborexant, a dual orexin receptor antagonist, is an in-house discovered and developed small molecule compound by Eisai, which inhibits orexin by binding competitively to two subtypes of orexin neuron receptors (orexin receptor 1 and 2).^[4]

About Purdue Pharma L.P. 

Purdue Pharma L.P. and associated U.S. companies are privately-held pharmaceutical companies known for pioneering research in chronic pain. Purdue Pharma is engaged in the research, development, production and distribution of prescription and over-the-counter medicines, as well as hospital products. Purdue Pharma is committed to advancing the care of patients with quality products that make a positive impact on healthcare - and on lives. Purdue Pharma's headquarters are located in Stamford, Conn. For more information about Purdue Pharma, please visit http://www.purduepharma.com

About Eisai Co., Ltd.  

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as "giving first thought to patients and their families and to increasing the benefits health care provides," which we call our human health care (hhc) philosophy. With over 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realise our hhc philosophy by delivering innovative products in multiple therapeutic areas with high unmet medical needs, including Oncology and Neurology. 

As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit http://www.eisai.com

References 

1. Zee P, Vitiello M et al. Circadian Rhythm Sleep Disorder: Irregular Sleep Wake Rhythm Type. Sleep Medicine Clinics 2009 1;4:213-218  

2. Clinicaltrials.gov. Study of the Efficacy and Safety of Lemborexant in Subjects 55 Years and Older With Insomnia Disorder. Available at: https://clinicaltrials.gov/ct2/show/NCT02783729?term=lemborexant&rank=1 Accessed October 2016 

3. Beuckmann C et al. Preclinical Pharmacological Characterisation of E2006, a Novel Dual Orexin Receptor Antagonist for Insomnia Treatment, Poster presented at Japanese Sleep Meeting 2014 

4. Scammell T et al. Orexin Receptors: Pharmacology and Therapeutic Opportunities. Annual Review of Pharmacology and Toxicology 2011;51:243-266 

November 2016   
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