APL-130277: Interim pilot trial data

Interim data from 9 healthy volunteers in the single-arm, placebo-controlled pilot CTH-104 trial showed that a single dose of 25 mg sublingual APL-130277 was well tolerated. Cynapsus said the 25 mg dose of APL-130277 did result in more adverse events with a greater severity than that seen with the 15 mg dose of APL-130277 in a previous trial, but the side effects were mild to moderate and were not dose limiting. The company also said the 25 mg dose of APL-130277 produced a concentration of apomorphine in the blood associated with an expected minimum efficacious concentration - about 3 ng/mL - for over 2 hours.

Cynapsus previously reported data from the placebo-controlled, crossover pilot CTH-103 trial in 29 healthy volunteers showing that 10 and 15 mg doses of sublingual APL-130277 were better tolerated than subcutaneous apomorphine. Additionally, the company 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 (see BioCentury, Jan. 20). ...