Acorda's experimental Parkinson's disease drug CVT-301 hits main goal of late-stage trial

Acorda Therapeutics' experimental drug CVT-301 demonstrated a significant improvement in motor function versus placebo in people with Parkinson's disease experiencing OFF periods in a Phase III study, the company reported Thursday. The drugmaker indicated that it plans to seek FDA approval of the therapy, which is an inhalable formulation of levodopa, by the end of the second quarter, with an application in Europe targeted by the end of the year.

The SPAN-PD trial randomised 339 people with Parkinson's disease who experience motor fluctuations to receive one of two doses of CVT-301 or placebo. Acorda noted that all participants were on a stable regimen of oral carbidopa and levodopa, and were also maintained on their other existing Parkinson's disease therapies.

The study's main goal was the change at week 12 in Unified Parkinson's Disease Rating Scale-Part 3 (UPDRS III) score relative to placebo at 30 minutes post-treatment for the higher dose of CVT-301. Results showed that the UPDRS III change for the higher dose of CVT-301 was -9.83 compared to -5.91 for placebo. Meanwhile, key secondary endpoints, measured at week 12, include the proportion of participants achieving an ON state within 60 minutes of treatment and maintained at 60 minutes, as well as change in UPDRS III score at 10 and 20 minutes following treatment.

Acorda indicated that detailed results will be presented at a future medical meeting. The drugmaker is also conducting two studies to assess the long-term safety profile of CVT-301, with up to 12-month data expected by the end of the first quarter. Acorda gained CVT-301 via its purchase of Civitas Therapeutics in 2014.