Acorda Therapeutics, Inc. (NASDAQ:ACOR) Files An 8-K

Results from Phase 1, Phase 2a and preclinical studies of CVT-301, an inhaled form of levodopa, have been featured in the current edition of Science Translational Medicine. Acorda Therapeutics, Inc. (NASDAQ:ACOR) is developing CVT-301 for the treatment of OFF periods in people with Parkinson’s disease (PD).

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As PD progresses, people with Parkinson’s experience OFF periods, which are characterized by the re-emergence of PD symptoms. These include motor symptoms such as impaired movement, muscle stiffness, and tremor, as well as non-motor symptoms. This re-emergence can occur even when an individual’s treatment regimen has been optimized. OFF periods typically increase in frequency during the course of the disease.

“OFF periods can be hugely disruptive to the lives of people with Parkinson’s and their families, and are considered one of the greatest unmet medical needs in the treatment of Parkinson’s,” said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. “CVT-301 is an inhaled powder form of levodopa that is being studied in combination with standard of care Parkinson’s disease regimens. Following two successful Phase 2 clinical trials1,2, our Phase 3 program is assessing the extent to which CVT-301, used when people with Parkinson’s begin to experience OFF periods, can restore motor function. If approved, CVT-301 may provide a valuable new treatment option for these individuals.”

Acorda’s Phase 3 clinical program comprises a Phase 3 safety and efficacy study as well as general and special population safety studies. The program is designed to confirm the efficacy and safety profile of CVT-301 and support global regulatory marketing authorization applications. The Company expects to announce results from its randomized, placebo-controlled Phase 3 trial in Q1 2017.

About Parkinson’s Disease and OFF Periods

There are approximately one million people in the U.S. and 1.2 million people in Europe diagnosed with Parkinson’s disease (PD). PD is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine, which causes impairment of motor function

including impaired movement, muscle stiffness and tremors. Non-motor symptoms are also common; they include anxiety, depression, sleep difficulties and gastrointestinal (GI) disorders among others.

In the United States, approximately 350,000 people with Parkinson’s experience OFF periods.

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 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 L-dopa to the lung. Oral medication can be associated with slow and variable 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 successful results of two Phase 2 trials, Acorda initiated a Phase 3 clinical program that includes a safety and efficacy study as well as general and special population safety studies. The efficacy trial has enrolled 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. The Company expects to announce results from this study in Q1 2017.

Early CVT-301 clinical studies were funded in part by grants from The Michael J. Fox Foundation for Parkinson’s Research.

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