Top Page | English | 简体中文 | 繁體中文 | 한국어 | 日本語
Thursday, 21 March 2019, 23:25 HKT/SGT
Share:
    

Source: Eisai
Biogen and Eisai to Discontinue Phase 3 ENGAGE and EMERGE Trials of aducanumab in Alzheimer's Disease
Independent data monitoring committee advises aducanumab unlikely to meet primary endpoints, leading to decision to discontinue the trials

Cambridge, MA, Mar 21, 2019 - (JCN Newswire) - Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) announced the decision to discontinue the global Phase 3 trials, ENGAGE and EMERGE, designed to evaluate the efficacy and safety of aducanumab in patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease dementia. The decision to stop the trials is based on results of a futility analysis conducted by an independent data monitoring committee, which indicated the trials were unlikely to meet their primary endpoint upon completion. The recommendation to stop the studies was not based on safety concerns.

"This disappointing news confirms the complexity of treating Alzheimer's disease and the need to further advance knowledge in neuroscience. We are incredibly grateful to all the Alzheimer's disease patients, their families and the investigators who participated in the trials and contributed greatly to this research," said Michel Vounatsos, chief executive officer at Biogen. "Biogen's history has been based on pioneering innovation, learning from successes and setbacks. Driven by our steadfast commitment to patients and our strong business foundation, we will continue advancing our pipeline of potential therapies in Alzheimer's disease and innovative medicines for patients suffering from diseases of high unmet need."

Detailed data from the ENGAGE and EMERGE studies will be presented at future medical meetings to inform ongoing research. ENGAGE and EMERGE are global Phase 3 multicenter, randomized, double- blind, placebo-controlled, parallel-group studies designed to evaluate the efficacy and safety of aducanumab. The primary objective of the study was to evaluate the efficacy of monthly doses of aducanumab as compared with placebo in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. Secondary objectives were to assess the effect of monthly doses of aducanumab as compared to placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (ADAS-Cog 13), and AD Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL-MCI).

As part of this decision, the EVOLVE Phase 2 safety study and the long-term extension of the PRIME Phase1b study of aducanumab will also be discontinued. Initiation of the aducanumab Phase 3 secondary prevention trial will be assessed while the data from ENGAGE and EMERGE are further evaluated.

About Aducanumab

Aducanumab (BIIB037) is an investigational compound being studied for the treatment of early Alzheimer's disease. Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Aducanumab is a human monoclonal antibody (mAb) derived from a de-identified library of B cells collected from healthy elderly subjects with no signs of cognitive impairment or cognitively impaired elderly subjects with unusually slow cognitive decline using Neurimmune's technology platform called Reverse Translational Medicine (RTM). Since October 2017, Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally. In addition, the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of aducanumab, a process allowing priority reviews by the FDA for drugs deemed as having potential to treat serious conditions and tackle key unmet medical needs.

About Biogen

At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is focused on advancing neuroscience research programs in Alzheimer's disease and dementia, MS and neuroimmunology, movement disorders, neuromuscular disorders, acute neurology, neurocognitive disorders, pain, and ophthalmology. Biogen also manufactures and commercializes biosimilars of advanced biologics.

We routinely post information that may be important to investors on our website at www.biogen.com.


About Eisai

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 approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products in various therapeutic areas with high unmet medical needs, including Neurology and Oncology.

In its medium-term business plan EWAY2025, Eisai is aiming to become a "Medico Societal Innovator" (a company that changes society through creating medicines and providing solutions), and is working on establishment of ecosystem platform business utilizing various data such as a large amount of clinical data, experiences, and know-how.

For more information about Eisai Co., Ltd., please visit https://www.eisai.co.jp.

Contact:
Biogen Inc. David Caouette 
TEL: +1-617-679-4945
E-mail: [email protected]

Eisai Co., Ltd.
Public Relations Department 
TEL: +81-(0)3-3817-5120 

Eisai Inc.
Public Relations Department 
TEL: +1-551-262-2686


Mar 21, 2019 23:25 HKT/SGT
Source: Eisai

Eisai (TSE: 4523)

Topic: Press release summary
Sectors: BioTech
http://www.acnnewswire.com
From the Asia Corporate News Network


Copyright © 2020 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.



Eisai
Feb 25, 2020 08:10 HKT/SGT
Eisai and FUJI YAKUHIN Conclude License Agreement Concerning the Development and Distribution of Dotinurad, a Treatment for Hyperuricemia and Gout, in China
Feb 21, 2020 16:55 HKT/SGT
Eisai Receives the President's Award of the Japan Techno-Economics Society at the 8th Technology Management and Innovation Awards
Jan 29, 2020 07:37 HKT/SGT
Eisai Commences Joint Research and Development of Cancer Gene Panel Test With Personal Genome Diagnostics Inc. Using Liquid Biopsy to Accelerate Next-Generation Drug Discovery and Development
Jan 23, 2020 14:57 HKT/SGT
Eisai: Dayvigo (Lemborexant) Approved for Treatment of Insomnia in Japan
Jan 23, 2020 14:46 HKT/SGT
Eisai: Approval of Antiepileptic Drug Fycompa in Japan for Monotherapy and Pediatric Indications for Partial-Onset Seizures, as well as a New Formulation
Jan 20, 2020 14:21 HKT/SGT
Eisai Rated "A", the Highest Rating in the CDP Climate Change Report 2019
Jan 6, 2020 08:57 HKT/SGT
Eisai's Fycompa for Adjunctive Treatment of Partial Onset Seizures Launched in China
Dec 24, 2019 16:22 HKT/SGT
Gilead and Eisai Enter Into Agreement in Japan for the Co-Promotion of the Investigational Rheumatoid Arthritis Therapy Filgotinib, Pending Regulatory Approval
Dec 23, 2019 08:17 HKT/SGT
U.S. FDA Approves Eisai's Dayvigo (Lemborexant) for Treatment of Insomnia in Adult Patients
Dec 10, 2019 08:02 HKT/SGT
Commencement of Major Renovation of Tsukuba Research Laboratories as Eisai Global Drug Discovery Center Aiming for Connecting Human and Human, and Data, and the World
More news >>
 News Alerts
Copyright © 2020 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Privacy Policy | Terms of Use | RSS
US: +1 800 291 0906 | Beijing: +86 400 879 3881 | Hong Kong: +852 2217 2912 | Singapore: +65 6304 8926 | Tokyo: +81 3 6859 8575

Connect With us: