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.
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?