Biogen Enrolls First Patient in Global Phase 3 Study of BIIB093 (IV Glibenclamide) for Large Hemispheric Infarction
September 04 2018 - 6:30AM
Biogen Enrolls First Patient in Global Phase 3 Study of BIIB093 (IV
Glibenclamide) for Large Hemispheric Infarction
Biogen (Nasdaq: BIIB) announced today the enrollment of the first
patient in the global Phase 3 clinical study CHARM, designed to
evaluate BIIB093 (intravenous (IV) glibenclamide) for the
prevention and treatment of severe cerebral edema in large
hemispheric infarction (LHI), one of the most severe types of
ischemic stroke where brain swelling (cerebral edema) often leads
to high morbidity and mortality.
“As pioneers in neuroscience, Biogen is dedicated to advancing
innovative approaches for investigational drugs in acute
neurological conditions with limited or no treatments by leveraging
our core expertise,” said Michael Ehlers, M.D., Ph.D., executive
vice president, research and development at Biogen. “We believe IV
glibenclamide could represent a first-in-class therapy with the aim
of giving physicians an effective option to improve patient
outcomes and reduce mortality risk. LHI is a severe type of
ischemic stroke with high mortality (40 percent to 80 percent) and
no currently available therapy. BIIB093 has the potential to be the
first major innovation in stroke in over 20 years, and we believe
the advancement to Phase 3 represents a significant milestone in
our stroke clinical program.”
The CHARM study is an international, multicenter, randomized,
double-blind, placebo-controlled, Phase 3 study that aims to enroll
680 patients with LHI in approximately 20 countries. It will
evaluate the efficacy and safety of IV glibenclamide treatment
within 10 hours following stroke onset. The primary endpoint is the
modified Rankin Scale (mRS), a functional outcome, assessed at 90
days.
Each year approximately 1.7 million ischemic strokes occur in
the U.S., Europe and Japan, and approximately 15 percent of these
are classified as LHI. In preclinical studies, IV glibenclamide has
been shown to inhibit SUR1-TRPM4 channels that mediate
stroke-related brain swelling. Phase 2 proof-of-concept studies
have demonstrated the potential of IV glibenclamide to reduce brain
swelling associated with disability and mortality in individuals
with LHI. IV glibenclamide was granted Orphan Drug Designation by
the U.S. Food and Drug Administration (FDA) for the treatment of
severe cerebral edema in patients with acute ischemic stroke. The
FDA has also granted the CHARM study Special Protocol Assessment
and IV glibenclamide Fast Track Designation.
For more information about the Phase 3 study, visit
www.clinicaltrials.gov (NCT02864953).
About BIIB093 (IV Glibenclamide)IV
glibenclamide is an investigational compound in development for the
prevention and treatment of severe cerebral edema due to large
hemispheric infarctions (LHI). IV glibenclamide is a high affinity
inhibitor of SUR1-TRPM4 channels, which are upregulated following
ischemia and trauma. Opening of these channels can lead to cerebral
edema, midline shift, increased intracranial pressure and brain
herniation, resulting in permanent disability or death. Biogen
acquired the IV glibenclamide asset from Remedy Pharmaceuticals
following completion of the Phase 2 GAMES-RP study.
IV glibenclamide was previously evaluated in the Phase 2
GAMES-RP study with a primary endpoint measuring the proportion of
patients who achieved an mRS score of 0–4 at 90 days without
undergoing decompressive craniectomy. Although this study did not
meet the primary endpoint, IV glibenclamide demonstrated potential
positive effects on functional outcomes and mortality, supported by
biomarkers and imaging measures of brain swelling. Mortality at 30
days was reduced from 36 percent in the placebo group to 15 percent
in IV glibenclamide-treated patients (p=0.03). In addition, in
patients 70 years of age and younger, 90-day functional outcomes
were statistically significantly improved (p=0.048) in the IV
glibenclamide group versus placebo. These clinical effects
correlated with a significant decrease in the concentration of
metalloproteinase-9 (MMP-9), a biomarker associated with
extracellular matrix breakdown following stroke, in the IV
glibenclamide-treated group. The IV glibenclamide-treated group at
approximately 72 hours showed a significant reduction in midline
shift (p=0.0006), an imaging marker of neurological deterioration
and poor outcomes including death.
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. 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, and today has the
leading portfolio of medicines to treat multiple sclerosis; has
introduced the first and only approved treatment for spinal
muscular atrophy; and is focused on advancing neuroscience research
programs in Alzheimer’s disease and dementia, multiple sclerosis
and neuroimmunology, movement disorders, neuromuscular disorders,
pain, ophthalmology, neuropsychiatry and acute neurology. Biogen
also manufactures and commercializes biosimilars of advanced
biologics.
We routinely post information that may be important to investors
on our website at www.biogen.com. To learn more, please visit
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Biogen Safe Harbor StatementThis press 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 relating to the
potential clinical effects of IV glibenclamide, the potential of
Biogen’s commercial business and pipeline programs, including IV
glibenclamide 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” 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 IV
glibenclamide; 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 IV glibenclamide; the occurrence of adverse safety
events; unexpected costs or delays; failure to protect and enforce
Biogen’s data, intellectual property and other proprietary rights
and uncertainties relating to intellectual property claims and
challenges; or we may encounter other unexpected hurdles. The
foregoing sets forth many, but not all, of the factors that could
cause actual results to differ from Biogen’s expectations in any
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and expectations and speak only as of the date of this press
release. Biogen does 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
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