Acorda Therapeutics, Inc. presented data from its Phase III SPAN-PD clinical trial of CVT-301, which showed a statistically significant improvement in motor function in people with Parkinson’s experiencing OFF periods.
The findings, along with interim results from a long-term safety study, were presented at the International Congress of Parkinson’s Disease and Movement Disorders (MDS), in Vancouver, British Columbia.
CVT-301 is an inhaled formula of levodopa (L-dopa). The inhaled formula is designed to reach the brain faster by bypassing the digestive system. It is an investigational drug in development for symptoms of OFF periods in people with Parkinson’s taking a carbidopa/levodopa regimen. OFF periods—when Parkinson’s symptoms reemerge—usually occur just prior to taking the next dose of levodopa, but may occur unpredictably as well.
Key findings from SPAN-PD study
The 12-week, placebo controlled trial enrolled 339 participants taking a stable regimen of oral carbidopa/levodopa. All patients maintained any other existing therapies.
Patients were randomized into receiving either a high dose (84 mg) of CVT-301, low dose (60 mg) of CVT-301, or placebo. Medication was self-administered up to five times daily.
Patients on the high dose showed a 9.83 score on the Unified Parkinson’s Disease Rating Scale-Part 3 (UPDRS III) versus a 3.91 score for placebo.
Multiple secondary endpoints, including achievement of an ON state with maintenance through 60 minutes and Patient Global Impression of Change, were supportive of the primary endpoint result, according to a company statement.
The most commonly reported adverse events in the CVT-301 84 mg group compared to the placebo group were cough, upper respiratory tract infection, nausea, sputum discoloration, and dyskinesia. When cough was reported, it was typically characterized as mild. Two of 114 participants receiving CVT-301 84 mg discontinued the study due to cough.
Key findings from long-term safety study
Acorda also announced interim data from an ongoing long-term safety study (CVT-301-005) at MDS. The 52-week open-label study compares treatment with CVT-301 84 mg with an observational control group. Participants were randomized to receive either the CVT-301 84 mg or control.
The primary objective of this study is to assess pulmonary function. Measures include Forced Expiratory Volume in 1 second (FEV1) and diffusing capacity of the lung for carbon monoxide (DLco).
There were no statistical differences in the mean changes in FEV1 and DLco from baseline to week 52 between the CVT-301 84 mg and observational control groups.
Acorda plans to file a New Drug Application for CVT-301 with the U.S. Food and Drug Administration by the end of the second quarter of 2017, and a Marketing Authorization Application with the European Medicines Agency (EMA) by the end of the year.
Filed Under: Drug Discovery