Acorda Presents Phase 1 Data on CVT-427 for Acute Treatment of Migraine at 58th Annual Scientific Meeting of the American Headache Society

ARDSLEY, N.Y.–(BUSINESS WIRE)– Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced pharmacokinetic
(PK) data from a Phase 1 study of CVT-427, an inhaled formulation of
zolmitriptan, resulting in increased bioavailability and faster
absorption compared to oral and nasal administration of the same active
ingredient in healthy adults. The data on CVT-427, an investigational
agent under development for the acute treatment of migraines, will be
presented on June 10^th, 2016, at the 58^th Annual
Scientific Meeting of the American Headache Society, in San Diego, CA.

“When surveyed, the majority of migraine sufferers said rapid pain
relief is one of the most important factors influencing their medication
preference,” said Rick Batycky, Ph.D., Acorda Therapeutics’ Chief
Technology Officer. “We’re encouraged by the findings of this PK study,
which support advancing development of CVT-427 for the acute treatment
of migraine.”

This Phase 1, open-label, intra-patient, single ascending dose trial
enrolled 21 healthy adults; 17 completed all treatments. Each subject
first received successively, single doses of the zolmitriptan reference
formulations, a 5 mg oral tablet and a 5 mg nasal spray. Subjects then
received four individual pre-metered doses of CVT-427 (0.825 mg (0.6 mg
delivered to the lung), 1.65 mg (1.2 mg), 3.0 mg (2.4 mg), and 6.0 mg
(4.8 mg) zolmitriptan). There was a one or two day washout period
between each administration.

The oral and nasal spray formulations had a median T_max of
1.5 hours and 3.0 hours, respectively; all four dose levels of CVT-427
had a median T_max of 0.17 hours.

The mean C_max for the oral formulation was 8.7 ng/mL, and the
nasal spray formulation was 8.1 ng/mL. The mean C_max values
for CVT-427 were 6.0 ng/mL (0.825 mg dose), 11.8 ng/mL (1.65 mg), 17.8
ng/mL (3.0 mg), and 35.0 ng/mL (6.0 mg).

The mean AUC_0-24 (ng·hr/mL) values for the reference
formulations were 49.0 for the oral, and 50.8 for the nasal spray,
whereas the mean AUC_0-24 values for CVT-427 were 14.7 (0.825
mg dose), 27.3 (1.65 mg), 47.1 (3.0 mg), and 91.0 (6.0 mg). Coefficient
of variation for AUC_0-24 with reference products ranged from
37.6%-38.4% compared with 26.7%-29.9% for CVT-427, showing less
variability.

PK parameters (including bioavailability) of the reference formulations
observed in the trial matched published reports. The study found that
CVT-427 had better bioavailability than the reference formulations with
less variability in plasma concentration.

There were no serious adverse events, dose limiting toxicities, or study
discontinuations due to adverse events (AEs) reported for CVT-427. The
most commonly reported treatment-emergent AEs for CVT-427 (≥10%) were
cough (0.825 mg – 11%, 1.65 mg – 11%, 3.0 mg – 22%, 6.0 mg – 18%), chest
discomfort (0.825 mg – 11%), headache (1.65 mg – 11%) and feeling hot
(3.0 mg – 11%, 6.0 mg – 24%). Other than cough, single dose CVT-427
tolerability was generally consistent with the known safety profile of
zolmitriptan.

“Tolerability and Pharmacokinetics of Zolmitriptan Administered via
CVT-427, a Novel Pulmonary Delivery System,” (Poster #PF72LB) will be
presented on Friday, June 10^th from 1:15pm – 2:30pm Pacific
Time. Herbert R. Henney III, PharmD, Vice President, Clinical
Pharmacology for Acorda, will present the poster. This study was
supported by Acorda Therapeutics, Inc.

More detailed information on the meeting can be found on the conference
website: http://www.americanheadachesociety.org/58th_annual_scientific_meeting/

About CVT-427

CVT-427 is an inhaled formulation of zolmitriptan that uses the
Company’s proprietary ARCUS^® technology. Zolmitriptan belongs
to a class of drugs known as triptans, which are a leading therapy for
acute treatment of migraines. An estimated 36 million people in the
United States, and over 40 million people in Europe, suffer from
migraines.

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 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. There
are currently two clinical-stage programs using the ARCUS technology:
CVT-301 (Phase 3) is in development as a treatment for symptoms of OFF
periods in Parkinson’s disease; CVT-427 (Phase 1) is in development for
the acute treatment of migraines. Acorda has an extensive patent
portfolio relating to CVT-301, CVT-427 and the ARCUS technology, which
covers aspects of the formulated drug product, the inhaler, the method
of drug delivery and manufacturing processes.

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 has an industry leading pipeline of novel neurological therapies
addressing a range of disorders, including Parkinson’s disease,
post-stroke walking difficulties, migraine, and multiple sclerosis.
Acorda markets three FDA-approved therapies, including AMPYRA^® (dalfampridine)
Extended Release Tablets, 10 mg.

For more information, please visit the Company’s website at: www.acorda.com.

Forward-Looking Statement

This press release includes forward-looking statements. 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 complete the Biotie transaction on a timely basis; the
ability to realize the benefits anticipated from the Biotie and Civitas
transactions, among other reasons because acquired development programs
are generally subject to all the risks inherent in the drug development
process and our knowledge of the risks specifically relevant to acquired
programs generally improves over time; the ability to successfully
integrate Biotie’s operations and Civitas’ operations, respectively,
into our operations; we may need to raise additional funds to finance
our expanded operations and may not be able to do so on acceptable
terms; our ability to successfully market and sell
Ampyra (dalfampridine) Extended Release Tablets, 10 mg 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 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, any other
products under development, or the products that we will acquire when we
complete the Biotie transaction; the occurrence of adverse safety events
with our products; delays in obtaining or failure to obtain and maintain
regulatory approval of or to successfully market Fampyra outside of the
U.S. and our dependence on our collaborator 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 our filings
with the Securities and Exchange Commission. We may not actually achieve
the goals or plans described in our forward-looking statements, and
investors should not place undue reliance on these statements.
Forward-looking statements made in this presentation are made only as of
the date hereof, and we disclaim any intent or obligation to update any
forward-looking statements as a result of developments occurring after
the date of this presentation.

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