Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that data from a Phase 2b clinical trial of CVT-301 in Parkinson’s disease (PD) will be featured during the Movement Disorders Invited Science Session at the upcoming 68th Annual Meeting of the American Academy of Neurology, being held in Vancouver, Canada. Invited Science Sessions are intended to highlight cutting-edge research in selected therapeutic categories.
“Approximately 350,000 people with PD in the U.S. experience OFF periods, which can be very disruptive. There is a great need for additional treatment options that improve motor function when an OFF period occurs,” said Burkhard Blank, M.D., interim Chief Medical Officer of Acorda. “Based on the results of the CVT-301 Phase 2b study, we initiated a Phase 3 trial to continue evaluating the safety and efficacy of CVT-301. Inhaled levodopa, or CVT-301, is being studied as a novel approach to treating OFF periods, which can be one of the most challenging aspects of PD.”
Peter LeWitt, M.D., M.Med.Sc., Professor of Neurology, Wayne State University School of Medicine, Director of the PD and Movement Disorders Program at Henry Ford Hospital in West Bloomfield, MI, will present, “Inhaled Levodopa (CVT-301) Provides Rapid Improvement of OFF States in Parkinson’s Disease” as one of six platform presentations selected for the Movement Disorders Invited Science Session on April 19th. The data will be presented at 4:50 p.m. Pacific time. A poster reporting on this study was previously presented at the 19th International Congress of Parkinson's Disease and Movement Disorders.
CVT-301 is an inhaled levodopa (L-dopa) under development for the treatment of OFF periods in Parkinson’s disease. OFF periods are characterized by a re-emergence of PD symptoms, including motor symptoms such as the impaired ability to move, muscle stiffness and tremor. This re-emergence can occur even when treatment regimens, including oral L-dopa and other PD medications, have been optimized.
In addition to the Invited Science Session, the Company is presenting two posters on the CVT-301 Phase 2b trial at the meeting:
- “Patients’ experience of Parkinson’s disease following treatment with inhaled levodopa: results from a phase 2b study,” (Poster #351) will be presented on April 20th from 8:30am to 7:00pm.
- “Effect of patient characteristics on motor function in response to 35-50 mg of inhaled levodopa (CVT-301) in patients with Parkinson's disease: results from a phase 2b study,” (Poster #372) will be presented on April 20th from 8:30am to 7:00pm.
More detailed information on the meeting can be found on the conference website: https://www.aan.com/conferences/2016-annual-meeting
About CVT-301/Phase 3 Program
CVT-301 is an investigational agent being developed as a self-administered, inhaled levodopa (L-dopa) therapy for the as needed treatment of OFF periods in Parkinson’s disease. It is intended for use as an adjunctive therapy to a patient’s individually optimized oral L-dopa/carbidopa regimen.
CVT-301 utilizes Acorda’s ARCUS® platform for inhaled therapeutics, which delivers a precise dose of a dry powder formulation of levodopa to the lung. Oral medication can be associated with slow onset of action, as the medicine is absorbed through the gastrointestinal (digestive) tract before reaching the brain. Inhaled treatments, such as those that utilize our ARCUS technology, enter the body through the lungs and reach the brain shortly thereafter, bypassing the digestive system.
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 Unified Parkinson’s Disease Rating Scale Part 3 (UPDRS III) after administration of CVT-301 in patients experiencing an OFF period (30 minutes post dose). UPDRS III is an established scale to monitor PD motor impairment, and is considered a standard in the field.
More details about the study, including enrollment criteria, can be found at https://cvt301.acordatrials.com/en/patient/ or http://clinicaltrials.gov/ct2/show/NCT02240030?term=CVT-301&rank=2
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, epilepsy, post-stroke walking deficits, migraine, and multiple sclerosis. Acorda markets three FDA-approved therapies, including AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.
For more information, please visit www.acorda.com.
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 or at all; 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 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 (diazepam) Nasal Spray, 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, any other products under development, or the products that we would acquire if 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 release 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 release.
Jeff Macdonald, 914-326-5232