Tozadenant: Phase IIb data
Top-line data from a double-blind, international Phase IIb trial in 420 patients whose levodopa treatment was insufficient to control PD symptoms until their next dose showed that twice-daily oral tozadenant for 12 weeks met the primary endpoint of reducing mean daily "off" time in which patients experienced symptoms of their PD vs. placebo. Biotie said that tozadenant also met several secondary endpoints, including increasing "on" time in which patients were symptom free, improving UPDRS Part III and Parts I-III combined scores and improving clinician- and patient-assessed global impression scores. Biotie also said that the trial identified the "minimally efficacious and maximum feasible dose levels." Tozadenant was generally well tolerated. Patients received placebo or twice-daily 60, 120, 180 or 240 mg tozadenant for 12 weeks. ...