Cynapsus Therapeutics (OTCQX:CYNAF; TSX-V:CTH) has released positive data from its recently completed CTH-104 healthy volunteer pilot study of a single, 25-milligram sublingual strip (APL-130277) dose of apomorphine.
APL-130277 is an easy-to-administer, fast-acting reformulation of apomorphine, which is the only approved drug in the U.S., Europe, Japan and other countries for the acute rescue of “off” motor symptoms of Parkinson’s disease.
Anthony Giovinazzo
“Not only have we demonstrated dose proportionality of the doses tested in CTH-103 (10 mg and 15 mg) and CTH-104 (25mg), but we have demonstrated in CTH-104 that the 25 mg dose is sustained over an extended period of time (162 minutes) above the minimal efficacious plasma concentration of apomorphine (approximately 3ng/ml), which is believed to be a level demonstrating symptomatic relief of off symptoms,” president and CEO Anthony Giovinazzo said in a statement.
“Importantly, we believe we are closer to our goal of being able to provide neurologists and movement disorder specialists with a range of doses that are needed to treat their patients experiencing off episodes,” he added.
The company is moving forward to its next clinical study (CTH-105) in patients with Parkinson’s disease, who are naive to the use of apomorphine and who experience at least one daily “off” episode. The study is planned to examine the effect of APL- 130277 on relieving “off” episodes over a single day with a dose- titration used to determine dose strengths necessary for future clinical development.
Following a number of additional efficacy and safety studies, Cynapsus expects to begin preparation of a FDA 505(b)(2) NDA in 2016.
Dr. Albert Agro, CMO, said the pharmacokinetic data gathered to date not only supports delivery of the company’s formulation by the sublingual route, “but also gives us confidence that our formulation may offer several clinically important benefits. We look forward to demonstrating the effectiveness of our drug in Parkinson’s patients.”
