Cynapsus Therapeutics, a Canada-based speciality pharmaceutical company, has reported positive top-line data from its human volunteer pilot proof-of-concept Phase I study of APL 130277 to treat the symptoms of Parkinson’s disease.
APL-130277 is a solid dosage form of apomorphine hydrochloride. It dissolves rapidly when placed under the tongue, and is absorbed directly into the bloodstream from the mouth at levels typically obtained by injection.
The Phase I pilot study involved 15 healthy volunteers. Twelve were given APL-130277, while the remaining three received a placebo. The trial demonstrated that a sublingual APL-130277 formulation (3mg dose) had a good pharmacokinetic and safety / tolerability profile, with a mean T-max of 25 minutes.
In the placebo treated subjects, 33% had at least one adverse event during the treatment period, while 17% of subjects having at least one adverse event in the APL-130277 treatment group.
Cynapsus president and CEO Anthony Giovinazzo said the successful completion of the first-in-man study was an important de-risking event for APL-130277, and sets the stage for completing the clinical requirements over the next two years to qualify for an accelerated new drug application (NDA).
Cynapsus chief medical officer Albert Agro said the results confirm the hypothesis that a sublingual thin-film strip delivery of apomorphine is safe, well-tolerated and produces a rapid absorption profile that, after dose adjustment, mirrors that of a subcutaneous injection of apomorphine.
”Planning is now underway for the final configuration of the film strip system, for the full bioequivalence study and a subsequent safety study in patients, with Parkinson’s disease as vetted by the US Food and Drug Administration," Agro added.
The company intends to submit NDA for APL-130277 in 2013 or 2014 and expects out-licensing to an appropriate pharmaceutical partner before such an application is submitted.