Biogen Announces Topline Results From Phase 2 Study of Gosuranemab, an Anti-Tau Antibody, for Alzheimer’s Disease
June 16 2021 - 4:30PM
Biogen Announces Topline Results From Phase 2 Study of Gosuranemab,
an Anti-Tau Antibody, for Alzheimer’s Disease
Biogen Inc. (Nasdaq: BIIB) today announced topline results
from its Phase 2 TANGO study of gosuranemab (BIIB092), an
investigational anti-tau antibody that was being evaluated as a
potential treatment for Alzheimer’s disease.
Gosuranemab did not meet its primary efficacy endpoint of change
from baseline at week 78 on the Clinical Dementia Rating Scale-Sum
of Boxes (CDR-SB) compared to placebo in patients with mild
cognitive impairment (MCI) due to Alzheimer’s disease and mild
Alzheimer’s disease dementia. No treatment benefit was seen on
exploratory efficacy endpoints, including the Alzheimer’s Disease
Assessment Scale–Cognitive Subscale (ADAS-Cog 13), the Alzheimer
Disease Cooperative Study Activity of Daily Living (ADCS-ADL), the
Mini-Mental State Examination (MMSE) and the Functional Assessment
Questionnaire (FAQ). Gosuranemab was well-tolerated overall, and
safety outcomes were consistent with previous studies of the
molecule.
Gosuranemab is an antibody directed against the N-terminus of
tau. Target engagement was demonstrated with lowering of N-terminal
tau in cerebrospinal fluid (CSF), consistent with prior studies.
However, in the TANGO Study, no statistically significant treatment
effect was observed on tau-PET at week 78 for any of the dose
groups.
“While we are disappointed by the results of the Phase 2 study
of gosuranemab, we know that the path to innovation is not a
straight line, and that we always learn from each trial. We are
investing in a broad neuroscience pipeline, including other tau
approaches for Alzheimer’s disease,” said Alfred Sandrock, Jr.,
M.D., Ph.D., Head of Research and Development at Biogen. “We extend
our deepest gratitude to the participants, site staff and the
broader Alzheimer’s disease community who contributed to the TANGO
study.”
Based on these results, the TANGO study has been terminated.
Biogen will discontinue clinical development of gosuranemab.
Analyses of additional data, including CSF biomarkers, are ongoing,
and Biogen plans to present these TANGO results at an upcoming
medical congress.
About the Phase 2 TANGO Study The Phase 2 TANGO
(NCT03352557) study of gosuranemab was a 78-week double-blind,
placebo-controlled, parallel-group trial to evaluate both safety
and efficacy on slowing rates of clinical progression in subjects
with mild cognitive impairment (MCI) due to Alzheimer’s disease
(AD) or with mild AD, followed by a dose-blind long term extension
period. The study enrolled 654 participants across 97 sites.
Participants aged 50–80 years with gradual and progressive change
in memory function over more than 6 months, who met all of the
clinical criteria for MCI due to AD or mild AD, had a CDR-SB of 0.5
for MCI due to AD or 0.5 or 1 for mild AD, a MMSE score of 22 to 30
(inclusive), a CDR Memory Box score of ≥0.5 and demonstrating
amyloid-positivity by CSF or amyloid-PET were randomized to receive
IV low, medium or high dose gosuranemab or placebo, once every 4
weeks. The primary endpoint of the study was safety.
About BiogenAt 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 Charles
Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners
Walter Gilbert and Phillip Sharp. Today Biogen has the leading
portfolio of medicines to treat multiple sclerosis, has introduced
the first approved treatment for spinal muscular atrophy,
commercializes biosimilars of advanced biologics and is focused on
advancing research programs in multiple sclerosis and
neuroimmunology, Alzheimer’s disease and dementia, neuromuscular
disorders, movement disorders, ophthalmology, neuropsychiatry,
immunology, acute neurology and neuropathic pain.
We routinely post information that may be important to investors
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Biogen Safe Harbor StatementThis 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 results from the TANGO study;
the potential clinical effects of gosuranemab; data readouts and
presentations for gosuranemab; the identification and treatment of
Alzheimer’s disease; our research and development program for the
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