Acorda Presents Phase 1 Data on CVT-427 for Acute Treatment of Migraine at 58th
Annual Scientific Meeting of the American Headache Society
Increased bioavailability, faster absorption, and less variability in plasma concentrations of inhaled
zolmitriptan CVT-427, compared to oral and nasal delivery in healthy adults
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 10th, 2016, at the 58th 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 Tmax of 1.5 hours and 3.0 hours, respectively; all four dose
levels of CVT-427 had a median Tmax of 0.17 hours.
The mean Cmax for the oral formulation was 8.7 ng/mL, and the nasal spray formulation was 8.1 ng/mL. The mean
Cmax 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 AUC0-24 (ng·hr/mL) values for the reference formulations were 49.0 for the oral, and 50.8 for the nasal
spray, whereas the mean AUC0-24 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 AUC0-24 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 10th 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.
Acorda Therapeutics
Jeff Macdonald, 914-326-5232
jmacdonald@acorda.com
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