$1.4M grant from Bill & Melinda Gates
Foundation will address challenges to treating premature infants in
developing countries
Company to collaborate with Massachusetts
Institute of Technology
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the
Bill & Melinda Gates Foundation has awarded the Company a $1.4
million grant to support the development of a formulation and
delivery system for a dry powder version of lung surfactant, a drug
used to treat neonatal respiratory distress syndrome (RDS). The
formulation will be based on the Company’s proprietary ARCUS
technology, and will be produced in collaboration with the
Massachusetts Institute of Technology (MIT).
RDS is a condition affecting newborns in which fluid collects in
the lungs' air sacs; it most commonly affects infants born
prematurely. It can be fatal, or lead to severe, chronic health
issues caused by a lack of oxygen getting to the baby’s brain and
other organs. The syndrome is caused by the infants’ inability to
produce enough surfactant, a liquid lining the inside of the lungs.
Delivering liquid surfactant to the lungs via intubation is the
standard of care. Intubation poses problems in the developing world
due to resource and infrastructure limitations, including the need
to refrigerate surfactant, access to sterile medical supplies,
access to potable water and a lack of healthcare professionals
trained in intubation. This grant will support the development of a
portable and easily administered inhaled form of surfactant, which
may present a more practical alternative for use in developing
areas of the world.
“Using the ARCUS technology to develop an inhaled formulation of
surfactant has the potential to expand access to this life-saving
treatment in developing countries. ARCUS-formulated medications
studied to date have been self-administered and stored at room
temperature; these features have the potential to eliminate some of
the barriers that prevent more widespread use of surfactant to
treat infants with RDS,” said Rick Batycky, Chief Technology
Officer of Acorda Therapeutics. “The ARCUS technology has a wide
range of potential applications. With the support of the Gates
Foundation, we’re excited to explore this technology to improve
health outcomes for infants in areas with constrained healthcare
infrastructures. ”
“Some of the early research that led to the ARCUS technology was
conducted at MIT, so it’s very gratifying to see its continued
development,” said Robert Langer, Ph.D., David H. Koch Institute
Professor of the Massachusetts Institute of Technology. “We’re
excited that it has the potential to help newborns with RDS, where
there is a significant unmet medical need.”
ARCUS technology is used in CVT-301, an inhalable form of
levodopa being investigated by Acorda in Phase 3 trials to treat
OFF episodes in people with Parkinson’s disease. It has also been
used in formulating CVT-427, a treatment for migraines in
preclinical testing. The ARCUS technology has been used to
successfully deliver more than one million doses to patients in
clinical trials of various products.
About ARCUS® Technology
Acorda’s proprietary ARCUS technology platform is a dry-powder
pulmonary delivery system that has potential applications in
multiple disease areas. This platform allows consistent and
precise delivery of significantly larger doses of medication than
are possible with conventional pulmonary systems. The ARCUS inhaler
is breath-actuated, operated by the user putting their lips to the
device and simply breathing in.
The ARCUS technology has been used to successfully deliver more
than one million doses to patients in clinical trials of various
products. CVT-301 is the most advanced drug candidate using the
ARCUS technology. Acorda has an extensive patent portfolio relating
to CVT-301 and the ARCUS technology, which covers aspects of the
formulated drug product, the inhaler, the method of drug delivery
and manufacturing processes for CVT-301.
About CVT-301
CVT-301 is being developed as a self-administered, inhaled
levodopa therapy for treatment of OFF episodes in Parkinson’s
disease. This is an adjunctive therapy to a patient’s individually
optimized oral L-dopa regimen. Acorda’s proprietary
ARCUS technology provides a precise dose of a dry powder
formulation of L-dopa to the lung to enable rapid and predictable
absorption. CVT-301 is delivered through a pocket-size,
breath-actuated inhaler designed to be patient-friendly.
Based on the results of the Phase 2b trial, Acorda has initiated
a Phase 3 clinical trial that is expected to enroll approximately
345 participants across three arms: 50mg, 35mg, or placebo. These
are the same doses used in the Phase 2b study. The primary outcome
measure is improvement on the UPDRS III after administration of
CVT-301.
More details about the study, including enrollment criteria, can
be found at www.acorda.com or
http://clinicaltrials.gov/ct2/show/NCT02240030?term=CVT-301&rank=2
About CVT-427
CVT-427 is an inhaled triptan being investigated for the
treatment of acute migraines. The Company anticipates beginning a
Phase 1 clinical program in 2015. CVT-427 utilizes the ARCUS
technology platform.
About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a
biotechnology company focused on developing therapies that restore
function and improve the lives of people with neurological
disorders.
Acorda markets three FDA-approved therapies, including
AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. The
Company has one of the leading pipelines in the industry of novel
neurological therapies. Acorda is currently developing a number of
clinical and preclinical stage therapies. This pipeline addresses a
range of disorders including post-stroke walking deficits,
Parkinson’s disease, epilepsy, neuropathic pain, heart failure, MS
and spinal cord injury.
For more information, please visit the Company’s website
at: www.acorda.com.
Forward Looking Statements
This press release includes forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements, other than statements of historical facts,
regarding management's expectations, beliefs, goals, plans or
prospects should be considered forward-looking. These statements
are subject to risks and uncertainties that could cause actual
results to differ materially, including the ability to realize the
benefits anticipated from the Civitas transaction and to
successfully integrate Civitas' operations into our operations; our
ability to successfully market and sell Ampyra in the U.S.; third
party payers (including governmental agencies) may not reimburse
for the use of Ampyra or our other products at acceptable rates or
at all and may impose restrictive prior authorization requirements
that limit or block prescriptions; the risk of unfavorable results
from future studies of Ampyra or from our other research and
development programs, including CVT-301, Plumiaz, or any other
acquired or in-licensed programs; we may not be able to complete
development of, obtain regulatory approval for, or successfully
market CVT-301, Plumiaz, or any other products under development;
we may need to raise additional funds to finance our expanded
operations and may not be able to do so on acceptable terms; the
occurrence of adverse safety events with our products; delays in
obtaining or failure to obtain regulatory approval of or to
successfully market Fampyra outside of the U.S. and our dependence
on our collaboration partner Biogen in connection therewith;
competition; failure to protect our intellectual property, to
defend against the intellectual property claims of others or to
obtain third party intellectual property licenses needed for the
commercialization of our products; and, failure to comply with
regulatory requirements could result in adverse action by
regulatory agencies.
These and other risks are described in greater detail
in Acorda Therapeutics' filings with the Securities
and Exchange Commission. Acorda may not actually achieve the goals
or plans described in its forward-looking statements, and investors
should not place undue reliance on these statements.
Forward-looking statements made in this release are made only as of
the date hereof, and Acorda disclaims any intent or obligation to
update any forward-looking statements as a result of developments
occurring after the date of this release.
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version on businesswire.com: http://www.businesswire.com/news/home/20150722005107/en/
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
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