BioCentury
ARTICLE | Clinical News

APL-130277: Pilot trial data

January 20, 2014 8:00 AM UTC

Top-line data from the placebo-controlled, crossover pilot CTH103 trial in 29 healthy volunteers showed that sublingual APL-130277 was better tolerated than subcutaneous apomorphine. Patients received 10 or 15 mg APL-130277 and were crossed over to 2 and 3 mg subcutaneous apomorphine, respectively. Cynapsus said the pharmacokinetic profile of APL-130277 was proportional between doses and that exposures above the minimum expected efficacious level were similar to or longer than exposures seen following treatment with subcutaneous apomorphine. The company also said there were dose-limiting adverse events at the 3 mg subcutaneous apomorphine dose that prevented dosing of a third cohort to compare a 25 mg dose of APL-130277 to a 4 mg dose of subcutaneous apomorphine.

This quarter, Cynapsus plans to complete a single-arm pharmacokinetic trial in healthy volunteers to evaluate the 25 mg dose of APL-130277. By year end, the company also plans to complete small efficacy trials with APL-130277 in apomorphine-naïve and apomorphine-experienced PD patients. A safety trial in apomorphine-naïve PD patients is slated to be completed by year end 2015. ...