BIIB Biogen Inc

Biogen Inc. (Nasdaq: BIIB) announced it will present new data from its Alzheimer’s disease (AD) portfolio at the upcoming International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™ 2024), taking place March 5-9 in Lisbon, Portugal and virtually. The presentations include new data for its oral small molecule inhibitor of tau aggregation (BIIB113), as well as presentations providing insights into the underlying mechanisms of Alzheimer’s disease.

“These data reflect our approach of exploring multiple pathologies and modalities in Alzheimer’s disease to create a leading portfolio that can transform the course of Alzheimer’s care,” said Priya Singhal, M.D., M.P.H., Executive Vice President, Head of Development at Biogen. “Our ongoing investments in areas of Alzheimer’s research reinforce our commitment to push the boundaries of innovation and make a real difference in the lives of those affected by this complex disease.”

Biogen presentations will provide new data on brain target engagement and the safety profile in healthy volunteers of an oral small molecule O-GlcNAcase (OGA) enzyme inhibitor intended to reduce tau aggregation (BIIB113). In addition to BIIB113, Biogen is researching the potential of tau reduction in AD with its investigational antisense oligonucleotide targeting the microtubule associated protein tau (MAPT) gene (BIIB080). Other presentations will discuss the long-term efficacy of lecanemab as well as the presence of alpha-synuclein pathology in AD which could inform future research on its role in AD clinical progression.

Key presentations include:

• Oral presentation: Results of the first in-human, randomized, blinded, placebo-controlled, single- and multiple-ascending dose study of BIIB113 in healthy volunteers. Friday, March 8, 9:55-10:10 AM GMT / 4:55-5:10 AM ET.
• Oral presentation: Distribution of Alpha-Synuclein co-pathology in MCI, mild Alzheimer’s disease and progressive supranuclear palsy clinical trial cohorts. Friday, March 8, 6:55-7:10 PM GMT / 1:55-2:10 PM ET.
• Oral presentation: Treatment with lecanemab disrupts tau accumulation across brain regions in early Alzheimer’s disease. Presented by Eisai. Thursday, March 7, 1:50-2:05 PM GMT / 8:50-9:05 AM ET.
• Oral presentation: Lecanemab for the treatment of early Alzheimer’s disease; the extension of efficacy results from Clarity AD. Presented by Eisai. Saturday, March 9, 9:10-9:25 AM GMT / 4:10-4:25 AM ET.
• On-demand oral presentation: A Neuro-Dynamic Quantitative Systems Pharmacology (QSP) Model for Alzheimer’s disease Incorporating Amyloid and Tau Pathophysiology, online.
• Poster presentation: Minimum Inclusion Criteria and Relation to Subsequent Cognitive Decline, P#0250, Wednesday, March 6, 9:00 AM GMT.
• E-poster presentation: Occupancy of BIIB113, an inhibitor of the enzyme O-GlcNAcase (OGA) in the human brain.

BIIB080 is licensed from Ionis.

About BiogenFounded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.

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Biogen Safe Harbor 

This news release contains forward-looking statements, the potential clinical effects of lecenamab, BIIB113 and BIIB080; the potential benefits, safety and efficacy of lecenamab, BIIB113 and BIIB080; the clinical development program for lecenamab, BIIB113 and BIIB080; the identification and treatment of Alzheimer’s and Parkinson’s Diseases; our research and development program for the treatment of ALS; the potential of our commercial business and pipeline programs, including lecenamab, BIIB113 and BIIB080; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on our forward-looking statements.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, uncertainty of success in the development and potential commercialization of lecenamab, BIIB113 and BIIB080; the risk that we may not fully enroll our clinical trials or enrollment will take longer than expected; unexpected concerns may arise from additional data, analysis or results obtained during our clinical trials; 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 BIIB113 and BIIB080; the occurrence of adverse safety events; the risks of unexpected hurdles, costs or delays; 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; 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 U.S. Securities and Exchange Commission. These statements speak only as of the date of this news release.

We do not undertake any obligation to publicly update any forward-looking statements.

MEDIA CONTACT:BiogenJack Cox+ 1 781 464 3260public.affairs@biogen.com	INVESTOR CONTACT:BiogenChuck Triano+1 781 464 2442IR@biogen.com