rHIgM22 well-tolerated at all tested doses
Antibody detected in cerebrospinal fluid
Beginning second Phase 1 clinical trial in
2Q15
Acorda Therapeutics, Inc. (Nasdaq:ACOR) today presented data
from a Phase 1 clinical trial of rHIgM22, a remyelinating antibody
being studied for the treatment of multiple sclerosis (MS). Safety
data showed rHIgM22 was well-tolerated in each of the five tested
doses, supporting additional clinical development. In addition,
testing detected rHIgM22 in cerebrospinal fluid (CSF), indicating
the drug’s access to the central nervous system. These data were
presented at the 67th American Academy of Neurology Annual
Meeting in Washington, DC.
“In this study, rHIgM22 was well-tolerated over the full range
of dose levels tested. Furthermore, we were able to verify that
rHIgM22 is present in the CSF, showing that the antibody is
available to the brain,” said Anthony Caggiano, M.D., Ph.D.,
Acorda’s Senior Vice President of Research and Development. “We
plan to advance our clinical program based on these data; the next
study will include patients experiencing acute relapses. The
combined results of these two studies will inform subsequent
trials, which we anticipate will enroll both stable patients and
those experiencing active relapses.”
This was a placebo-controlled, single-dose, escalating study in
72 patients with clinically stable MS to explore dose tolerability
for six months after treatment. rHIgM22 was well-tolerated at all
doses tested, with no safety signals identified. There were no
dose-limiting toxicities and no serious adverse events in any of
the five rHIgM22 dose levels in the study. The data presented
included the concentration of rHIgM22 in the CSF at two days and
four weeks after IV infusion. The antibody was measured at levels
expected for antibodies of this class. There were no significant
changes from baseline in clinical measures including MRI, magnetic
resonance spectroscopy, Expanded Disability Status Scale, Timed
25-Foot Walk, and low contrast visual acuity.
The most commonly observed adverse events (>5% in the
combined rHIgM22 treatment groups) reported in the study were:
headache, contact dermatitis, multiple sclerosis relapse,
infusion site hematoma, fatigue, arthralgia,
back pain, muscular weakness, neck pain,
pain in an extremity, pruritus, contusion, and flushing.
No participants withdrew due to adverse events. No safety signals
were identified by standard clinical MRI evaluations, or standard
clinical, laboratory or ECG assessments.
The data were presented in a poster, “Safety and Tolerability of
the Remyelinating Therapeutic Antibody rHIgM22 in Patients with
Stable Multiple Sclerosis” (poster presentation number P4.339).
Top-line safety and tolerability data were previously announced by
the Company in February 2015.
About MS and rHIgM22
Multiple sclerosis (MS) is a chronic, usually progressive
disease in which the immune system attacks and degrades the
function of nerve fibers in the brain and spinal cord by destroying
myelin (a process known as demyelination) and eventually the nerve
fibers themselves. Myelin is a fatty layer of membranes that
insulates nerves, facilitating the transmission of electrical
impulses through nerve pathways that control all neurological
functions. In people with MS, disruption in neurological function
often leads to impairments in movement, bowel/bladder function,
vision and sexual function.
The cells that make myelin, called oligodendrocytes, can
initially repair myelin damage. As MS progresses, the ability of
oligodendrocytes to repair areas of demyelination is not sufficient
to prevent permanent neurological injury. Currently, there are no
therapies that repair or restore myelin in demyelinating diseases
such as MS. If myelin is able to be repaired, it may restore
electrical conduction and may serve to protect the exposed nerve
fiber from further damage.
rHIgM22 is a recombinant human monoclonal antibody identified in
the laboratory of Moses Rodriguez, M.D. at Mayo Clinic.
In preclinical studies, rHIgM22 has been found to protect
oligodendrocytes and stimulate them to repair areas of
demyelination. rHIgM22 treatment also resulted in sustained
improvements in motor activity in preclinical models.
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, a
treatment to improve walking in patients with multiple sclerosis
(MS), as demonstrated by an increase in walking speed. 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.
AMPYRA (dalfampridine) Important Safety
Information
Do not take AMPYRA if you
- have ever had a seizure,
- have certain types of kidney problems,
or
- are allergic to dalfampridine
(4-aminopyridine), the active ingredient in AMPYRA.
Take AMPYRA exactly as prescribed by your doctor.
Before taking AMPYRA, tell your doctor if you
- have kidney problems or any other
medical conditions
- are taking compounded
4-aminopyridine
- are pregnant or plan to become
pregnant. It is not known if AMPYRA will harm your unborn
baby.
- are breast-feeding or plan to
breast-feed. It is not known if AMPYRA passes into your breast
milk. You and your doctor should decide if you will take AMPYRA or
breast-feed. You should not do both.
- are taking any other medicines
Stop taking AMPYRA and call your doctor right away if you have a
seizure while taking AMPYRA. You could have a seizure even if you
never had a seizure before. Your chance of having a seizure is
higher if you take too much AMPYRA or if your kidneys have a mild
decrease of function, which is common after age 50. Your doctor may
do a blood test to check how well your kidneys are working before
you start AMPYRA.
AMPYRA should not be taken with other forms of 4-aminopyridine
(4-AP, fampridine), since the active ingredient is the same.
AMPYRA may cause serious side effects, including
- severe allergic reactions. Stop taking
AMPYRA and call your doctor right away or get emergency medical
help if you have shortness of breath or trouble breathing, swelling
of your throat or tongue, or hives;
- kidney or bladder infections.
The most common adverse events for AMPYRA in MS patients were
urinary tract infection, trouble sleeping, dizziness, headache,
nausea, weakness, back pain, problems with balance, multiple
sclerosis relapse, burning, tingling, or itching of your skin,
irritation in your nose and throat, constipation, indigestion, and
pain in your throat.
Please see the Patient Medication Guide at
https://ampyra.com/medication-guide.pdf.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
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.
Acorda TherapeuticsJeff Macdonald,
914-326-5232jmacdonald@acorda.com
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