Cynapsus wins Michael J. Fox grant for study
Cynapsus Therapeutics (TSX-V:CTH) has been awarded a grant of $947,925 from the Michael J. Fox Foundation for Parkinson’s Research to support clinical studies to develop APL-130277, an oral thin film strip reformulation of apomorphine.
Apomorphine is an approved drug in the US, Europe and several other countries as a subcutaneous injection or infusion for Parkinson’s patients experiencing daily “off” or motor fluctuation episodes. APL-130277 is potentially the only oral formulation of apomorphine, and as such will provide patients with a convenient and more tolerable alternative to multiple daily injections.
“Improved methods of delivery for apomorphine, which has been shown to effectively treat ‘off-episodes’ in motor fluctuation, have been a goal of pharmaceutical research for at least a decade,” Dr. Maurizio Facheris, associate director of research programs at MJFF, said in a statement.
“Preliminary data around Cynapsus’ novel formulation (APL-130277) show promise for a more frequent and effective use of this dopaminergic drug. We are hopeful that these clinical studies will support this promise, and drive APL-130277 further along the pipeline of therapeutic development,” he added.
Cynapsus CEO Anthony Giovinazzo said the company is grateful to The Michael J. Fox Foundation, as well as their internal and external reviewers, for having judged the APL-130277 project to be worthy of support.
“We are optimistic that APL-130277 has the potential to help many of the existing Parkinson’s patients manage their daily quality of life, the use of caregivers and the use of their Levodopa treatments,” he added.
Dr. Albert Agro, CMO of Cynapsus, said the foundation’s support with this pre-bioequivalence clinical study will be instrumental in helping the company complete the requirements recommended by the FDA in a pre-IND meeting.
“We have confidence that our sublingual film strip will succeed in achieving a pharmacokinetic profile that will satisfy requirements of the FDA’s 505(b)2 approval process and lead to a timely NDA submission sometime in 2014,” he added.