Eisai to Present New 12-month Safety & Effectiveness Data from Phase 3 Lemborexant SUNRISE 2 Study and New Patient and Cohabitant Insights about Insomnia and Toll on Next-Day Functioning at World Sleep Congress

WOODCLIFF LAKE, N.J., Sept. 19, 2019 /PRNewswire/ -- Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announced that new long-term, Phase 3 data and additional analyses of lemborexant will be highlighted in eight presentations at the 2019 World Sleep Congress, taking place September 20-25 in Vancouver, Canada. An additional poster will feature new survey findings about the perceptions of insomnia and sleeping difficulties amongst patients and household cohabitants, including next-day functioning. Lemborexant is an investigational agent being studied for the treatment of insomnia, a sleep-wake disorder, and as a potential treatment of irregular sleep-wake rhythm disorder (ISWRD) in patients with Alzheimer's disease.

Presentations include new long-term (12-month) effectiveness and safety results, including an assessment of lemborexant compared to placebo on subject-reported fatigue, from SUNRISE 2 (Study 303); an analysis of the effect of lemborexant on sleep architecture in older adults with insomnia disorder from SUNRISE 1 (Study 304), the first Phase 3 head-to-head study including pre-specified endpoints versus zolpidem ER; and a pooled analysis of subject-reported outcomes from both Phase 3 studies which assessed the effect of lemborexant on sleep onset and maintenance and insomnia disease severity:    

• Oral 1: Long-term Effectiveness and Safety of Lemborexant in Adults with Insomnia Disorder: 12-month Results From SUNRISE 2
• Oral 1: Effect of Lemborexant Compared With Placebo and Zolpidem Extended Release on Sleep Architecture in Older Adults with Insomnia Disorder
• Poster 153: Long-Term Effect of Lemborexant on Fatigue in Subjects with Insomnia Disorder: Patient-Reported Outcome from the 6-Month Placebo-Controlled Treatment Period of the Phase 3 Study SUNRISE 2
• Poster 118: Impact of Lemborexant Treatment on the Patient Global Impression – Insomnia Scale
• Poster 160: Patient-reported Sleep Onset and Sleep Maintenance: Pooled Responder Analyses of Lemborexant Phase 3 Studies
• Poster 131: The Impact of Lemborexant Treatment on Insomnia Disease Severity: Results From a Pooled Analysis of Two Phase 3 Studies
• Poster 127: Do Insomnia Patients in Insomnia Clinical Trials Endorse Daytime Sleepiness?

Eisai will also present a poster on the findings from "How America Sleeps and Wakes," a company-sponsored survey, conducted by The Harris Poll, which evaluated the perceptions of both patients and household cohabitants regarding the burden of insomnia and sleep difficulties on next-day functioning.

• Poster 139: Insomnia Impacts the Patient and the Household: Perceptions of the Burden of Insomnia on Next-Day Functioning

"We look forward to sharing new information that expand the understanding of the long-term effectiveness and safety data of lemborexant, as well as its effect on multiple measures of insomnia in a broad age range of patients," said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "Given Eisai's focus on patients and their families, we are especially pleased to share results from our patient and household cohabitant survey, "How America Sleeps and Wakes," as we seek to further understand the unmet needs of people living with insomnia and its impact on an entire household."

Additionally, results of a pre-clinical study of lemborexant in the first mouse model of ISWRD in Alzheimer's disease will be featured in an oral presentation:

• Oral 30: Senescence-Accelerated Mouse Prone-8 SAMP8 Mice As A Preclinical Model For Irregular Sleep Wake Rhythm Disorder and Efficacy Of The Dual Orexin (Hypocretin) Receptor Antagonist Lemborexant

Information about completed and ongoing lemborexant clinical studies is available at clinicaltrials.gov.

Earlier this year, the U.S. Food and Drug Administration accepted for review the New Drug Application for lemborexant for the treatment of insomnia. A target Prescription Drug User Fee Act date is set for December 27, 2019.

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

<Notes to editors>

1. About Lemborexant
   Lemborexant is a novel investigational small molecule compound, discovered and developed by Eisai in-house scientists, that inhibits orexin signaling by binding competitively to both orexin receptor subtypes (orexin receptor 1 and 2). In individuals with normal daily sleep-wake rhythms, orexin signaling is believed to promote periods of wakefulness. In individuals with sleep-wake disorders, it is possible that orexin signaling that regulates wakefulness is not functioning normally, suggesting that inhibiting inappropriate orexin signaling may enable initiation and maintenance of sleep. Eisai is investigating lemborexant as a potential treatment option for multiple sleep-wake disorders, such as insomnia. Additionally, a Phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder and mild to moderate Alzheimer's dementia is underway.
                                    
2. About SUNRISE 1 (Study 304)¹
   SUNRISE 1 was a multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study evaluating the efficacy and safety of lemborexant in 1,006 male or female adult patients 55 years and older (45 percent of patients were 65 years and older) with insomnia disorder conducted in North America and Europe. SUNRISE 1 included a pre-randomization phase of up to 35 days (including a two-week placebo run-in period) and a randomization phase comprised of a 30-day treatment period and a minimum two-week period without treatment prior to the end-of-study visit. In this study, patients were randomized to receive placebo or one of three treatment regimens (lemborexant 5 mg, lemborexant 10 mg, zolpidem ER 6.25 mg).
                                
   The primary objective for SUNRISE 1 was to demonstrate using polysomnography that lemborexant at either the 5 mg or 10 mg dose is superior to placebo on objective sleep onset, as measured by latency to persistent sleep after the last two nights of one month of treatment. Key secondary objectives included change from baseline in sleep efficiency and wake after sleep onset for both lemborexant doses compared to placebo, and wake after sleep onset in the second half of the night for both lemborexant doses compared to zolpidem ER, each after the last two nights of one month of treatment.
                                    
3. About SUNRISE 2 (Study 303)²
   SUNRISE 2 was a 12-month multicenter, global, randomized, controlled, double-blind, parallel-group study of the efficacy and safety of lemborexant in 949 male or female adult participants 18 to 88 years of age with insomnia disorder. SUNRISE 2 included a pre-randomization phase of up to 35 days (including a two-week placebo run-in period) and a randomization phase comprised of a six-month placebo-controlled treatment period, a six-month period of only active treatment and a two-week period without treatment prior to the end-of-study-visit. In this study, during the placebo-controlled treatment period, patients were randomized to receive placebo or one of two treatment regimens (lemborexant 5 mg or 10 mg). During the active-only treatment period, patients who received placebo during the first period were re-randomized to receive lemborexant 5 mg or 10 mg. Patients who received active treatment during the first period continued on the treatment to which they were originally randomized. The primary objective was to determine the efficacy of lemborexant 5 mg and 10 mg compared to placebo on patient-reported (subjective) sleep onset latency after six months of treatment. Key secondary endpoints were mean change from baseline in subjective sleep efficiency and subjective wake after sleep onset (sWASO) for lemborexant 5 mg and 10 mg compared to placebo after six months of treatment.
                                      
4. About Sleep Disorders
   Population studies show that sleep disorders affect many more people worldwide than previously thought.³ Insomnia symptoms affect approximately 30 percent of the adult population worldwide.⁴ Insomnia disorder is characterized by difficulty falling asleep, staying asleep or both, despite an adequate opportunity to sleep, which can lead to daytime consequences, such as fatigue, difficulty concentrating and irritability.^5,6
                                   
   Sleeping well is essential for good health, including brain health. Poor sleep is associated with a wide range of health consequences, including an increased risk of hypertension, accidental injury, diabetes, obesity, depression, heart attack, stroke and dementia, as well as adverse effects on mood and behavior.^5,7
                                                     
   Experimental studies in animals and humans provide evidence of associations between sleep and disease risk factors, diseases and mortality.⁸ Studies suggest an optimal sleep duration between seven and eight hours.⁹
                                                  
   Women are 1.4 times more likely than men to suffer from insomnia.¹⁰ Older adults also have higher prevalence of insomnia; aging is often accompanied by changes in sleep patterns, including disrupted sleep, frequent waking, and early waking, that can lead to less sleep time.¹¹
                                                        
5. About Eisai Inc.
   At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts 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). 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 and follow us on Twitter and LinkedIn.

References
¹ Eisai Inc. A multicenter, randomized, double-blind, placebo-controlled, active comparator, parallel-group study of the efficacy and safety of lemborexant in subjects 55 years and older with insomnia disorder. (E2006-G000-304). (Clinicaltrials.gov Identifier NCT02783729). 2018. Unpublished data on file.
² Eisai Inc. A long-term multicenter, randomized, double-blind, controlled, parallel-group study of the safety and efficacy of lemborexant in subjects with insomnia disorder (E2006-G000-303). (Clinicaltrials.gov Identifier NCT02952820). 2018. Unpublished data on file.
³ Ferrie JE, et al. Sleep epidemiology – a rapidly growing field. Int J Epidemiol. 2011;40(6):1431–1437.
⁴ Roth T. Insomnia: definition, prevalence, etiology and consequences. J Clin Sleep Med. 2007;3(5 Suppl):S7–S10. 
⁵ Institute of Medicine. Sleep disorders and sleep deprivation: An unmet public health problem. Washington, DC: National Academies Press. 2006.
⁶ Ohayon MM, et al. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002;6(2):97-111.
⁷ Pase MP, Himali JJ, Grima NA, et al. Sleep architecture and the risk of incident dementia in the community. Neurology. 2017;89(12):1244-1250.
⁸ Cappuccio FP, et al. Sleep and cardio-metabolic disease. Curr Cardiol Rep. 2017;19:110.
⁹ Cappuccio FP, et al. Sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies. Sleep. 2010;33(5):585-592.
¹⁰ Roth T, et al. Prevalence and perceived health associated with insomnia based on DSM-IV-TR; International Statistical Classification of Diseases and Related Health Problems, tenth revision; and Research Diagnostic Criteria/International Classification of Sleep Disorders, second edition criteria: results from the America Insomnia Survey. Biol Psychiatry. 2011;69:592– 600.
¹¹ Crowley K. Sleep and sleep disorders in older adults. Neuropsychol Rev. 2011;21(1):41-53.     

Contact:

Eisai Inc.
James Merse
551-502-2710
[email protected]            

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