Cynapsus Therapeutics, a speciality pharmaceutical company, has announced positive data from its recently completed CTH-104 healthy volunteer pilot study of a single 25mg 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 United States, Europe, Japan and other countries for the acute rescue of ‘off’ motor symptoms of Parkinson's disease.
Anthony Giovinazzo, president and CEO of Cynapsus commented, "The results from the CTH-104 study in human healthy volunteers are very important as we move forward with testing APL-130277 in Parkinson's patients. Not only have we demonstrated dose proportionality of the doses tested in CTH-103 (10mg and 15mg) and CTH-104 (25mg), but we have demonstrated in CTH-104 that the 25mg 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. 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. We look forward to moving on to our next clinical study (CTH-105) in patients with Parkinson's disease who are naïve to the use of apomorphine and who experience at least one daily ‘off’ episode."
Dr Albert Agro, chief Medical Officer at Cynapsus, also commented: "The pharmacokinetic data we have gathered to date not only supports delivery of our 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."
