Acorda Therapeutics, which recently announced a corporate restructuring, will focus on the late-stage development of its two therapies for Parkinson’s disease, CVT-301 and tozadenant. The news comes after a March 31 ruling by the U.S. District Court in Wilmington, Delaware, invalidated four Acorda patents related to multiple sclerosis therapy Ampyra.
Acorda, based in Ardsley, New York, plans to file a New Drug Application with the U.S. Food and Drug Administration (FDA) for the use of CVT-301 in patients with Parkinson’s. This application will be supported by the positive results obtained in a Phase 3 efficacy study (Study 004) and two long-term safety studies. The proposed brand name for this therapy is Inbrija.
Study 004 (NCT02240030) evaluated the efficacy and safety of inhaled CVT-301 compared to placebo in patients experiencing “off” episodes. Acorda will present results of this study at the International Congress of Parkinson’s Disease and Movement Disorders to be held June 4-8 in Vancouver.
CVT-301 is an inhaled formulation of levodopa (L-dopa) under development for Parkinson’s patients taking oral carbidopa/levodopa. It delivers a precise amount of the medication into the lungs and reaches the brain shortly after.
The two studies investigating the long-term safety of CVT-301 were known as CVT-301-005 (NCT02352363) and CVT-301-004E (NCT02242487). CVT-301-005 enrolled 271 Parkinson’s patients with no history of asthma or other chronic lung disease to assess pulmonary function after one year of treatment.
These patients received CVT-301 (84 mg) up to five times a day and standard of care. Results were compared to a control group of 127 patients who were only given standard of care. No difference was found between the two groups, showing that CVT-301 treatment does not change pulmonary function in patients with Parkinson’s. Common side effects included mild to non-severe cough, nasopharyngitis, dyskinesia and falls.
The CVT-301-004E study, still recruiting participants, has so far included 149 patients who were given 84 mg of CVT-301 and 146 patients who were treated with 60 mg. Safety findings were similar to those reported in the CVT-301-005 study.
This month, Acorda also launched the Phase 3 TOZ-CL-06 (NCT03051607) trial. This international, multicenter, open-label 12-month study will investigate the long-term safety of tozadenant in Parkinson’s patients experiencing off episodes. The first patient has already been dosed. A separate ongoing Phase 3 TOZ-CL-05 trial (NCT02453386) — on the safety and efficacy of tozadenant in treating off episodes in Parkinson’s patients using levodopa. The results of this study should be known by early 2018.