Cynapsus confirms Parkinson’s treatment in drug trial
Cynapsus Therapeutics (TSX-V:CTH) has released positive top-line data from a human volunteer proof-of-concept trial for APL-130277, a sublingual thin film strip formulation of apomorphine, for the treatment of motor fluctuations or “off episodes” in Parkinson’s disease.
The study showed a pharmacokinetic profile that compares favorably to injected apomorphine, with a mean T-max, or the time to maximum drug load in the bloodstream, of 25 minutes and good tolerability, confirming the potential of APL-130277.
“The successful completion of this first-in-man study is 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,” CEO Anthony Giovinazzo said in a statement.
“This significant achievement, combined with the recent announcement of our 500-neurologist survey that confirmed a potentially expanded market for this acute rescue treatment of the debilitating daily freezing episodes, sets a firm foundation of credibility and potential value,” he added.
Cynapsus CMO Dr. Albert Agro said the results “confirm our 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.”
He said the T-max of less than 25 minutes confirms that the sublingual delivery system is well equipped to provide therapeutic benefit to patients suffering from Parkinson’s disease who have “off episodes.”
A detailed analysis of the data is expected to be available within the next 30 days. 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, he added.
Apomorphine, a potent dopamine agonist, is currently the only drug approved specifically for the treatment of acute motor fluctuations or freezing in patients with advanced Parkinson’s disease. It is administered by injection and can lead to numerous side-effects.
APL-130277 is a solid dosage form of apomorphine hydrochloride that dissolves rapidly under the tongue, is absorbed directly into the blood stream from the mouth and reproduces the blood levels typically obtained by injection. APL-130277 allows for easy self-administration without the injection site side effects.