APL-130277: Phase II data
Top-line data from 16 apomorphine-naive PD patients in the open-label, U.S. Phase II CTH-105 trial showed that 10, 15, 20, 25 and 30 mg APL-130227 converted 14 patients from a severe "off" state in the morning to an "on" state. The company said clinically meaningful improvement in motor control occurred as early as 10 minutes after administration and lasted for >=90 minutes. Additionally, APL-130227 was associated with a 45% improvement in motor function based on the change in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III score from baseline. APL-130227 was well tolerated with no serious adverse events reported. Nausea was reported by 3 patients receiving 10, 15 or 20 mg APL-130227. The trial enrolled 19 patients who experienced >=1 daily “off” episode with a total duration of “off” in any 24-hour period of >=2 hours. ...