Biogen Highlights New Data at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD™) 2024 Annual Meeting
- Biogen to present new data on its Alzheimer's disease portfolio at the AD/PD™ 2024 conference.
- Presentations will cover insights into the underlying mechanisms of Alzheimer's disease.
- Focus on new data for oral small molecule inhibitor of tau aggregation (BIIB113) and potential tau reduction with investigational antisense oligonucleotide (BIIB080).
- Biogen emphasizes exploring multiple pathologies and modalities in Alzheimer's disease for innovative care.
- Key presentations include results of BIIB113 study in healthy volunteers, alpha-synuclein co-pathology distribution, lecanemab's efficacy in disrupting tau accumulation, and more.
- Research aims to push boundaries of innovation and make a real difference in Alzheimer's care.
- None.
Insights
From a neuroscientific perspective, the new data presented by Biogen on its Alzheimer's disease portfolio represents a significant advancement in the understanding of AD pathologies. The development of BIIB113, an oral small molecule inhibitor of tau aggregation, is particularly noteworthy. Tau proteins are integral to the stability of neuronal microtubules; their aggregation is a hallmark of AD and is associated with neurodegeneration. The safety profile and brain target engagement data in healthy volunteers provide a foundational understanding for the potential translational impact of BIIB113. Furthermore, the investigation into alpha-synuclein co-pathology addresses another protein aggregation commonly associated with Parkinson's disease but also present in AD, suggesting a more integrated approach to neurodegenerative disease research and potential cross-applicability of treatments.
The clinical trial design for BIIB113, as highlighted in the upcoming presentations, is crucial for assessing the drug's safety and efficacy. The randomized, blinded, placebo-controlled design of the first in-human study is the gold standard for determining causality in clinical outcomes. The ascending dose methodology allows for careful monitoring of the drug's effects at various levels, which is essential for establishing a safe and effective dosing regimen. Additionally, the long-term efficacy data of lecanemab will be of great interest to the medical community, as it may offer insights into the sustainability of treatment benefits over time and inform future trial designs for AD therapeutics.
In the pharmaceutical industry, the progression of drugs like BIIB113 and lecanemab through the clinical trial phases can have substantial implications for market dynamics. Biogen's focus on novel treatments for Alzheimer's disease taps into a high-need, high-value market, given the lack of curative treatments for this debilitating condition. The safety and target engagement data are early indicators of a drug's potential market viability. Positive results can lead to increased investor confidence and stock valuation, whereas any adverse findings could have the opposite effect. The presentations at AD/PD™ 2024 will likely be scrutinized by investors for signals on Biogen's future revenue streams and competitive positioning within the neurodegenerative treatment landscape.
- New data advances understanding of new approaches to treating Alzheimer’s disease
- Research on disease progression could help inform future clinical trials
CAMBRIDGE, Mass., March 04, 2024 (GLOBE NEWSWIRE) -- 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 Biogen
Founded 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.
We routinely post information that may be important to investors on our website at www.biogen.com. Follow us on social media - Twitter, LinkedIn, Facebook, YouTube.
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: Biogen Jack Cox + 1 781 464 3260 public.affairs@biogen.com | INVESTOR CONTACT: Biogen Chuck Triano +1 781 464 2442 IR@biogen.com |
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