Biogen Reports Top-Line Results from Phase 2 Study in Progressive Supranuclear Palsy
December 13 2019 - 7:30AM
Biogen Reports Top-Line Results from Phase 2 Study in Progressive
Supranuclear Palsy
Today, Biogen Inc. (Nasdaq: BIIB) announced topline results from
the Phase 2 PASSPORT study of gosuranemab (BIIB092) for progressive
supranuclear palsy (PSP). The primary endpoint, as measured by the
PSP rating scale (PSPRS) at week 52, was not statistically
significant. In addition, the study did not demonstrate efficacy on
key clinical secondary endpoints. Based on these results, Biogen
will discontinue development of gosuranemab for PSP and other
primary tauopathies.
“We are disappointed with the efficacy results of the Phase 2
PASSPORT study,” said Alfred Sandrock Jr., M.D., Ph.D., Executive
Vice President, Research and Development and Chief Medical Officer
at Biogen. “We remain unwavering in our commitment to advancing
therapies that have the potential to address the significant unmet
medical needs of people with neurodegenerative diseases who are
faced with limited to no treatment options.”
Safety results of the PASSPORT study were generally consistent
with previous studies of gosuranemab. Detailed results of this
study will be made available in a future scientific forum.
Biogen will continue its ongoing Phase 2 TANGO study of
gosuranemab for mild cognitive impairment due to Alzheimer’s
disease (AD) or mild AD, given differences in disease
pathology.
About GosuranemabGosuranemab (BIIB092) is a
humanized monoclonal antibody that targets N-terminal tau.
Gosuranemab-mediated removal of N-terminal tau is being studied to
evaluate whether it slows the progression of disease in
tauopathies.
TANGO, a Phase 2 study, is designed to evaluate the safety and
tolerability of gosuranemab in participants with mild cognitive
impairment due to Alzheimer’s disease or with mild Alzheimer’s
disease.
Biogen licensed gosuranemab from Bristol-Myers Squibb
Company.
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 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, neuromuscular disorders, movement disorders,
Alzheimer’s disease and dementia, ophthalmology, immunology,
neurocognitive disorders, acute neurology and pain.
We routinely post information that may be important to investors
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Biogen Safe Harbor Statement 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, including statements about results
from the Phase 2 PASSPORT study; the potential clinical effects of
gosuranemab; the potential benefits, safety and efficacy of
gosuranemab; the clinical development program, clinical trials,
data readouts and presentations related to gosuranemab; the
potential of our commercial business and pipeline programs,
including gosuranemab; 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 these statements
or the scientific data presented.
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
gosuranemab; 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 gosuranemab; the occurrence of adverse safety events; the
risks of other 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; and third
party collaboration risks. 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 are based on our current beliefs and
expectations and speak only as of the date of this news
release.
We do not undertake any obligation to publicly update any
forward-looking statements, whether as a result of new information,
future developments or otherwise.
MEDIA CONTACT: David Caouette +1 617 679
4945public.affairs@biogen.com |
INVESTOR CONTACT: Joe Mara+1 781 464
4471IR@biogen.com |
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