Acorda Therapeutics (ACOR) Announces Presentation of Significant CVT-301 Phase 2b Data in PD

April 20, 2016

Data from the Phase 2b clinical trial of CVT-301, published this week in the peer-reviewed journal Movement Disorders, showed that people with Parkinson’s disease (PD) experiencing OFF periods and who were treated with CVT-301 had significantly greater improvements in motor function than those treated with placebo. A treatment effect was evident at 10 minutes after dosing and was sustained for at least one hour, the longest time point at which patients were assessed.

Acorda Therapeutics, Inc. (Nasdaq: ACOR) is developing CVT-301 for the treatment of OFF periods in people with PD.

“Oral levodopa is a cornerstone of Parkinson’s disease treatment, but after chronic therapy, approximately half of people with PD who are treated with oral L-dopa experience OFF periods,” said Peter LeWitt, M.D., M.Med.Sc., Director of the PD and Movement Disorders Program at Henry Ford Hospital and lead author of the study. “OFF periods tend to increase in frequency, severity and duration during the course of the disease, and are among the most challenging experiences for people with this disorder. Based on the data from this Phase 2b clinical study, CVT-301 has the potential to restore motor function to people with Parkinson’s disease when they experience OFF periods, and this is now being studied in a Phase 3 clinical trial.”

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 of oral levodopa (L-dopa) and other standard of care medications have been optimized.

The Phase 2b trial was a randomized, double blind, placebo-controlled, multicenter study in 86 people with PD for the treatment of OFF periods. Participants were randomized to self-administer CVT-301 or placebo to the lung via an inhaler, as an adjunct to their established oral PD medications. Participants received 35mg of CVT-301 or placebo in study weeks 1 and 2, and 50mg of drug or placebo in weeks 3 and 4.

The primary endpoint was defined as the mean change from baseline OFF state in Unified Parkinson’s Disease Rating Scale motor function (UPDRS Part III) score, (measured at 10-60 minutes post dose) after 4 weeks of treatment. The UPDRS is an established assessment method to monitor PD motor impairment that has been used extensively in clinical research.

In this study, participants receiving CVT-301 showed a statistically significant and clinically important reduction in average UPDRS III score compared to placebo (p<0.01) and across all measured time points beginning at 10 and up to 60 minutes post-administration (p<0.05). There were no concerning safety signals observed in either CVT-301 dose group, with no increase relative to placebo in troublesome or non-troublesome dyskinesias during ON periods. There were no serious adverse events reported in the drug group, and the incidence of drug-related adverse events was similar between treatment groups (23% drug group; 21% placebo group). The most common adverse events were dizziness (7% drug group; 5% placebo), cough (7% drug group; 2% placebo) and nausea (7% drug group; 0% placebo); there were no adverse events related to cardiovascular or lung function. PD patients were able to self-administer treatment while in an OFF state.

Earlier this week, data included in this paper were featured at the 68th Annual Meeting of the American Academy of Neurology (AAN) during the Movement Disorders Invited Science Session. Data from the Phase 2b study were also previously presented at the International Congress of Parkinson’s Disease and Movement Disorders (MDS) annual meetings in 2014 and 2015. The 2015 presentation was recognized in the meeting’s Blue Ribbon Highlights Session.

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