{"id":3106,"date":"2019-02-04T00:00:00","date_gmt":"2021-03-18T06:55:29","guid":{"rendered":"https:\/\/www.eisai.com.cn\/?p=3106"},"modified":"2021-03-18T14:59:33","modified_gmt":"2021-03-18T06:59:33","slug":"total-synthesis-and-nonclinical-study-results-of-a-novel-anticancer-drug-candidate-e7130-derived-from-total-synthesis-of-halichondrin-found-in-joint-research-between-eisai-and-harvard-university-sci-2","status":"publish","type":"post","link":"https:\/\/www.eisai.com.cn\/en\/2019\/02\/04\/total-synthesis-and-nonclinical-study-results-of-a-novel-anticancer-drug-candidate-e7130-derived-from-total-synthesis-of-halichondrin-found-in-joint-research-between-eisai-and-harvard-university-sci-2\/","title":{"rendered":"Eisai and Purdue Pharma Present Efficacy and Safety Data from Second Pivotal Phase 3 Study at the Sleep Research Society\u2019s Conference: Advances in Sleep and Circadian Science"},"content":{"rendered":"<p><span class=\"sub\"><i><span lang=\"EN-US\">Six-month data show significant improvements in patient-reported measures of sleep onset and sleep maintenance for investigational agent lemborexant<\/span><\/i><\/span><em><span class=\"sub\"><i><span lang=\"EN-US\"><br \/>\n<\/span><\/i><i><span lang=\"EN-US\"><br \/>\n<\/span><\/i><\/span><\/em><\/p>\n<p>TOKYO and STAMFORD, Conn. \u2013 February 4, 2019 \u2013 Eisai Co., Ltd. (CEO: Haruo Naito, &#8220;Eisai&#8221;) and Purdue Pharma L.P. (President and CEO: Craig Landau, MD, &#8220;Purdue Pharma&#8221;) today announced six-month results from SUNRISE 2, a long-term Phase 3 clinical study evaluating the efficacy and safety of lemborexant, an investigational agent being developed for the treatment of insomnia, a sleep-wake disorder. Data were presented at the Sleep Research Society\u2019s Advances in Sleep and Circadian Science conference, taking place in Clearwater Beach, Florida, Feb. 1-4, 2019.<\/p>\n<p>SUNRISE 2 was a 12-month multicenter, global, randomized, controlled, double-blind, parallel-group study of the efficacy and safety of lemborexant in 949 adult patients (18 to 88 years of age) with insomnia disorder, which was characterized by difficulty falling asleep and\/or staying asleep. Approximately 28 percent of the patients randomized and treated were 65 years of age or older. During the first six months of the study, patients were randomized to receive either lemborexant 5 mg, lemborexant 10 mg, or placebo. The primary and key secondary efficacy objectives were assessed by patient self-reports via electronic sleep diaries.<\/p>\n<p>At the end of the six-month, placebo-controlled treatment period, treatment with lemborexant at either 5 mg or 10 mg resulted in statistically significant improvements compared to placebo in patient-reported (subjective) sleep onset latency (sSOL), the study\u2019s primary efficacy endpoint, and subjective sleep efficiency (sSE) and subjective wake after sleep onset (sWASO), the study\u2019s key secondary endpoints. Six-month results from the study showed that:<br \/>\n\u25cf\u00a0<span lang=\"EN-US\">Median reductions from baseline in sSOL with lemborexant 5 mg (<\/span><span lang=\"EN-US\">&#8211;<\/span><span lang=\"EN-US\">21.81 minutes) and 10 mg (<\/span><span lang=\"EN-US\">&#8211;<\/span><span lang=\"EN-US\">28.21 minutes) were larger and statistically significant compared to placebo (<\/span><span lang=\"EN-US\">&#8211;<\/span><span lang=\"EN-US\">11.43 minutes) at the end of month six (p&lt;0.0001 for all treatment groups).<br \/>\n<\/span>\u25cf\u00a0<span lang=\"EN-US\">Improvements from baseline, as measured by Least Squares Mean (LSM), in sSE with lemborexant 5 mg (14.19 percent, p=0.0001) and 10 mg (14.31 percent, p&lt;0.0001) were larger and statistically significant compared to placebo (9.64 percent) at the end of month six.<\/span><br \/>\n\u25cf\u00a0<span lang=\"EN-US\">Reductions from baseline in sWASO, as measured by LSM, with lemborexant 5 mg (<\/span><span lang=\"EN-US\">&#8211;<\/span><span lang=\"EN-US\">46.75 minutes, p=0.0005) and 10 mg (<\/span><span lang=\"EN-US\">&#8211;<\/span><span lang=\"EN-US\">41.95 minutes, p=0.0105) were larger and statistically significant compared with placebo (<\/span><span lang=\"EN-US\">&#8211;<\/span><span lang=\"EN-US\">29.28 minutes) at the end of month six.<\/span><\/p>\n<p>Most adverse events (AEs) reported were mild to moderate. Serious AEs were reported at a rate of 2.2 percent (lemborexant 5 mg), and 2.9 percent (lemborexant 10 mg), and 1.6 percent (placebo); only one was considered treatment-related. The most common AEs reported, greater than 5 percent in either lemborexant treatment arm and greater than placebo, were somnolence, headache, and influenza. Discontinuation rates due to AEs were comparable between placebo and lemborexant 5 mg (3.8 percent and 4.1 percent, respectively), and higher for lemborexant 10 mg (8.3 percent).<\/p>\n<p>&#8220;These findings add to the growing body of clinical data supporting the development of lemborexant for the treatment of insomnia, and we look forward to presenting 12-month results from the study in a future scientific forum,&#8221; said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. &#8220;It remains our aspiration to bring a medicine to physicians and patients that helps patients sleep well at night and wake well in the morning.&#8221;<\/p>\n<p>SUNRISE 2 is one of two Phase 3 safety and efficacy studies of lemborexant conducted by Eisai and Purdue Pharma.\u00a0These studies supported the New Drug Application for lemborexant for the treatment of insomnia, filed with the U.S. Food and Drug Administration, on December 27, 2018. In Japan, an application is scheduled to be filed within fiscal 2018.<\/p>\n<p>&#8220;The six-month findings from SUNRISE 2 are exciting, highlighting improvements in subjective measures of both sleep onset and sleep maintenance,&#8221; said John Renger, PhD, Head of Research &amp; Development and Regulatory Affairs, Purdue Pharma. &#8220;SUNRISE 2 was a robust Phase 3 clinical study in which the self-reported patient outcomes are encouraging as they reflect the patients\u2019 perception of lemborexant\u2019s impact on enabling the patient to both fall asleep faster and stay asleep longer.&#8221;<\/p>\n<p>Lemborexant, which acts on the orexin neurotransmitter system and is believed to regulate sleep and wake by dampening wakefulness without impeding the ability to awaken to external stimuli, is being jointly developed by Eisai and Purdue Pharma for the treatment of multiple sleep-wake disorders, including insomnia disorder. In addition to the treatment of insomnia disorder, a Phase 2 clinical study of lemborexant in patients with irregular sleep-wake rhythm disorder and mild to moderate Alzheimer\u2019s dementia is underway. Information about ongoing clinical studies is available at clinicaltrials.gov.<\/p>\n<p>Eisai and Purdue Pharma are striving to address new unmet medical needs and to improve the lives of patients and their families.<\/p>\n<p>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.<\/p>\n<h2 class=\"hdg-09\"><\/h2>\n<p class=\"txt\"><strong>Contacts:<br \/>\n<span class=\"hdg-inner\">Eisai Co., Ltd.<\/span><\/strong>\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0<span class=\"hdg-inner\"><b>Purdue Pharma L.P.<\/b><\/span><br \/>\nPublic Relations Department\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0Danielle Lewis<br \/>\n+81-(0)3-3817-5120\u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0 \u00a0\u00a0 \u00a0\u00a0+1-203-588-7653<\/p>\n<p><b>&lt;Notes to editors&gt;<\/b>\u00a0<b><br \/>\n1. About Lemborexant<\/b><br \/>\nLemborexant 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 which regulates wakefulness is not functioning normally, suggesting that inhibiting inappropriate orexin signaling may enable initiation and maintenance of sleep.<\/p>\n<p><b>2. About SUNRISE 2<sup>1<\/sup><\/b><br \/>\n<span lang=\"EN-US\">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\u00a0included 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 active-only treatment and a two-week period without treatment prior to the end-of-study visit.\u00a0In 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 at the end of 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 at the end of six months of treatment.<br \/>\n<\/span><br \/>\n<b>3. About Sleep Disorders<sup><br \/>\n<\/sup><\/b>Population studies show that sleep disorders affect many more people worldwide than previously thought.<sup>2\u00a0<\/sup>Insomnia disorder is the most common sleep disorder affecting approximately 30 percent of the adult population worldwide.<sup>2,3<\/sup>\u00a0Insomnia 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.<sup>4,5<\/sup><br \/>\nSleeping 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.<sup>4,6<\/sup><br \/>\nExperimental studies in animals and humans provide evidence of associations between sleep and disease risk factors, diseases and mortality.<sup>7<\/sup>\u00a0Studies suggest an optimal sleep duration between seven and eight hours.<sup>8<\/sup><br \/>\nWomen are 1.4 times more likely than men to suffer from insomnia.<sup>9\u00a0<\/sup>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.<sup>10<\/sup>\u00a0<b><\/p>\n<p>4.\u00a0About Eisai Co., Ltd<\/b><br \/>\nEisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as &#8220;giving first thought to patients and their families and to increasing the benefits health care provides,&#8221; which we call our\u00a0<span class=\"txt-i\">human health care<\/span>\u00a0(<i>hhc<\/i>) philosophy. With approximately 10,000 employees working across our global network of R&amp;D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our\u00a0<span class=\"txt-i\">hhc<\/span>\u00a0philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Neurology and Oncology.<br \/>\nFurthermore, we invest and participate in several partnership-based initiatives to improve access to medicines in developing and emerging countries.<br \/>\nFor more information about Eisai Co., Ltd., please visit\u00a0<a href=\"http:\/\/www.eisai.com\/\">www.eisai.com<\/a>\u00a0<b><\/p>\n<p>5. About Purdue Pharma L.P.<\/b><br \/>\nPurdue Pharma L.P. develops and provides prescription medicines that meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue Pharma is committed to supporting\u00a0national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue Pharma is pursuing a pipeline of new medications and technologies through internal research &amp; development and strategic industry partnerships. For more information, please visit\u00a0<a href=\"http:\/\/www.purduepharma.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">www.purduepharma.com<\/a>.<\/p>\n<p><b>References\u00a0<\/b><br \/>\n<sup>1\u00a0<\/sup>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.<br \/>\n<sup>2<\/sup>\u00a0Ferrie JE, et al. Sleep epidemiology \u2013 a rapidly growing field<i>. Int J Epidemiol.<\/i>2011;40(6):1431\u20131437.<br \/>\n<sup>3<\/sup>\u00a0Roth T. Insomnia: definition, prevalence, etiology and consequences.\u00a0<i>J Clin Sleep Med<\/i>. 2007;3(5 Suppl):S7\u2013S10.<br \/>\n<sup>4\u00a0<\/sup>Institute of Medicine. Sleep disorders and sleep deprivation: An unmet public health problem. Washington, DC: National Academies Press. 2006.<br \/>\n<sup>5<\/sup>\u00a0Ohayon MM, et al. Epidemiology of insomnia: what we know and what we still need to learn.\u00a0<i>Sleep Med Rev.<\/i>\u00a02002;6(2):97-111.<br \/>\n<sup>6<\/sup>\u00a0Pase MP, Himali JJ, Grima NA, et al. Sleep architecture and the risk of incident dementia in the community.\u00a0<i>Neurology<\/i>. 2017;89(12):1244-1250.<br \/>\n<sup>7<\/sup>\u00a0Cappuccio FP et al. Sleep and cardio-metabolic disease<i>. Curr Cardiol Rep<\/i>.\u00a02017;19:110.<br \/>\n<sup>8<\/sup>\u00a0Cappuccio FP et al.<i>\u00a0<\/i>Sleep duration and all-cause mortality: a systematic review and meta-analysis of prospective studies.<i>\u00a0Sleep.\u00a0<\/i>2010;33(5):585-592.<br \/>\n<sup>9\u00a0<\/sup>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<i>. Biol Psychiatry.<\/i>\u00a02011;69:592\u2013600.<br \/>\n<sup>10\u00a0<\/sup>Crowley, K.\u00a0Sleep and sleep disorders in older adults.\u00a0<i>Neuropsychol Rev<\/i>. 2011;21(1):41-53.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>TOKYO and STAMFORD, Conn. \u2013 February 4, 2019 \u2013 Eisai Co., Ltd. (CEO: Haruo Naito, &#8220;Eisai&#8221;) and Purdue Pharma L.P. (President and CEO: Craig Landau, MD, &#8220;Purdue Pharma&#8221;) today announced six-month results from SUNRISE 2, a long-term Phase 3 clinical study evaluating the efficacy and safety of lemborexant, an investigational agent being developed for the treatment of insomnia, a sleep-wake disorder. Data were presented at the Sleep Research Society\u2019s Advances in Sleep and Circadian Science conference, taking place in Clearwater Beach, Florida, Feb. 1-4, 2019.<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[28],"tags":[],"class_list":["post-3106","post","type-post","status-publish","format-standard","hentry","category-news-en"],"_links":{"self":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/3106"}],"collection":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/comments?post=3106"}],"version-history":[{"count":3,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/3106\/revisions"}],"predecessor-version":[{"id":3107,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/posts\/3106\/revisions\/3107"}],"wp:attachment":[{"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/media?parent=3106"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/categories?post=3106"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.eisai.com.cn\/wp-json\/wp\/v2\/tags?post=3106"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}