CAMBRIDGE -
The company's contributions to AAIC showcase its work to build a broad AD franchise across multiple targets and modalities, as well as to advance knowledge about early diagnosis, unmet patient needs and health system capacity to diagnose and treat people living with AD.
Biogen's AD portfolio of investigational assets includes aducanumab, an investigational treatment that, if approved, could meaningfully change the course of the disease. At the conference, Biogen will share an encore platform presentation of the previously reported topline results from the aducanumab Phase 3 EMERGE and ENGAGE studies. No new data from the studies are included in the encore presentation, which will be pre-recorded and followed by a live, virtual question and answer (Q&A) session. This presentation and Q&A session will be held on
In addition, Biogen's drug candidates and research will be featured in a platform presentation about the Phase 2 TANGO study to evaluate gosuranemab (BIIB092) in patients with early AD; a poster about the feasibility of clinical research studies reported by patients with behavioral variant frontotemporal dementia and their caregivers and a poster on tau protein interactions. Conference activities also include a virtual satellite symposium about early diagnosis and readying the health system for the potential entry of a disease-modifying treatment for AD.
About Aducanumab
Aducanumab (BIIB037) is an investigational human monoclonal antibody studied for the treatment of Alzheimer's disease. Based on clinical data, aducanumab has the potential to impact underlying disease pathophysiology, slow cognitive and functional decline and provide benefits on patients' ability to perform activities of daily living, including conducting personal finances, performing household chores, such as cleaning, shopping and doing laundry, and independently traveling out of the home. If approved, aducanumab would be the first treatment to meaningfully change the course of the disease for individuals living with Alzheimer's.
Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since
EMERGE and ENGAGE were 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 studies was to evaluate the efficacy of monthly doses of aducanumab as compared with placebo in reducing 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 decline as measured by the Mini-Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 Items (ADAS-Cog 13) and Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory Mild Cognitive Impairment Version (ADCS-ADL-MCI).
About BAN2401
BAN2401 is a humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between
About Gosuranemab
Gosuranemab (BIIB092) is a humanized monoclonal antibody that targets N-terminal tau. Gosuranemab is currently being evaluated in the Phase 2 TANGO study in participants with mild cognitive impairment due to Alzheimer's disease or with mild Alzheimer's disease. Biogen licensed gosuranemab from
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 as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by
Biogen Safe Harbor
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential clinical effects of aducanumab, BAN2401 and gosuranemab; the potential benefits, safety and efficacy of aducanumab, BAN2401 and gosuranemab; the results of the Phase 3 studies and Phase 1b study of aducanumab and the Phase 2 study of gosuranemab; the identification and treatment of Alzheimer's disease; potential regulatory approvals and the timing thereof; the anticipated benefits and potential of our collaboration arrangements with
These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; actual timing and content of submissions to and decisions made by the regulatory authorities regarding aducanumab; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of our drug candidates, including aducanumab, BAN2401 and gosuranemab; uncertainty of success in the development and potential commercialization of aducanumab; risks relating to the potential launch of aducanumab, including preparedness of healthcare providers to treat patients, the ability to obtain and maintain adequate reimbursement for aducanumab and other unexpected difficulties or hurdles; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the
Contact:
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Email: public.affairs@biogen.com
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