New Data Presented at AD/PD™ 2023 Show Biogen’s BIIB080 (MAPT ASO) Substantially Reduced Tau Protein Levels in Patients with Early-stage Alzheimer’s Disease
29 March 2023 - 11:45PM
New Data Presented at AD/PD™ 2023 Show Biogen’s BIIB080 (MAPT ASO)
Substantially Reduced Tau Protein Levels in Patients with
Early-stage Alzheimer’s Disease
Biogen Inc. (Nasdaq: BIIB) reported new promising Phase 1b clinical
data showing that the investigational antisense oligonucleotide
(ASO) therapy, BIIB080, reduced soluble tau protein in
cerebrospinal fluid (CSF) in a dose-dependent and sustained manner
in patients with early-stage Alzheimer’s disease (AD). BIIB080 also
reduced aggregated tau pathology, as measured by positron emission
tomography (PET) in all brain composites assessed. The primary
endpoint of the Phase 1b trial (week 25) and open-label long-term
extension study (through week 100) was safety and tolerability,
with biomarker data as an exploratory endpoint. The results were
presented at the International Conference on Alzheimer’s and
Parkinson’s Diseases (AD/PD™ 2023) held in Gothenburg, Sweden from
March 28 – April 1.
“The BIIB080 Phase 1b clinical study is the first to demonstrate
this magnitude of a reduction of tau PET across brain regions,”
said Priya Singhal, M.D., M.P.H., Executive Vice President, Head of
Development at Biogen. “Given the complexity and urgent unmet need
in Alzheimer’s disease, Biogen continues to evaluate multiple
modalities and targets including tau, which is believed to play a
critical role in cognitive decline.”
In patients with Alzheimer’s disease, tau protein can form
“tangles” which progressively accumulate in brain regions involved
in cognition.2 The accumulation of pathological tau tangles has
been shown to promote brain cell damage and death. BIIB080 is
designed to target microtubule-associated protein tau (MAPT) mRNA
and prevent production of tau protein.
The Phase 1b trial and its open-label long-term extension study
was designed to evaluate the safety and tolerability of multiple
dose levels of BIIB080 in patients with mild AD (n=46). In this
study, the majority of adverse events were mild or moderate in
severity, of which the most common were headache, back pain, and
post-lumbar puncture syndrome (PLPS). The results showed that
BIIB080 reduced biomarkers of soluble tau in CSF (t-tau and
p-tau181) in a dose-dependent and sustained manner, with all dose
groups showing approximately a 60% reduction from baseline CSF tau
levels by the end of the long-term extension (LTE). BIIB080
impacted aggregated tau pathology as measured by PET as early as
week 25 and up to the end of the LTE at week 100, including in
patients who began on placebo and received BIIB080 treatment
starting at week 25 in the long-term extension. By the end of the
LTE, BIIB080 reduced tau pathology in all dose groups across all
brain composites assessed.
The Phase 2 CELIA study of BIIB080 (NCT05399888) is in progress
and currently recruiting participants in the United States.
In December 2019, Biogen exercised a license option with Ionis
and obtained a worldwide, exclusive, royalty-bearing license to
develop and commercialize BIIB080 (tau ASO).
About BiogenFounded in 1978, Biogen is a
leading global biotechnology company that has pioneered multiple
breakthrough innovations including a broad portfolio of medicines
to treat multiple sclerosis, the first approved treatment for
spinal muscular atrophy, and two co-developed treatments to address
a defining pathology of Alzheimer’s disease. Biogen is advancing a
pipeline of potential novel therapies across neurology,
neuropsychiatry, specialized immunology and rare diseases and
remains acutely focused on its purpose of serving humanity through
science while advancing a healthier, more sustainable and equitable
world.
We routinely post information that may be important to investors
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Biogen Safe Harbor This news release
contains forward-looking statements, about the potential clinical
effects of BIIB080; the potential benefits, safety and efficacy of
BIIB080; potential regulatory discussions, submissions and
approvals and the timing thereof; the treatment of Alzheimer's
disease; the potential of Biogen's commercial business and pipeline
programs, including BIIB080; and risks and uncertainties associated
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Results in early-stage clinical studies may not be indicative of
full results or results from later stage or larger scale clinical
studies and do not ensure regulatory approval. You should not place
undue reliance on these statements.
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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 studies; the occurrence of adverse safety events;
risks of unexpected costs or delays; the risk of other unexpected
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________________________1 BrightFocus. Foundation. Tau Protein
and Alzheimer’s Disease: What’s the Connection?
https://www.brightfocus.org/alzheimers/article/tau-protein-and-alzheimers-disease-whats-connection.
Accessed March 2023.2 Alzheimer’s Association. Tau Topic Sheet.
https://www.alz.org/media/Documents/alzheimers-dementia-tau-ts.pdf.
Accessed February 2023.
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