Cynapsus Therapeutics Inc. has announced that it has been awarded a grant of USD$947,925 from The Michael J. Fox Foundation for Parkinson's Research (MJFF) to support clinical studies to develop APL-130277, a sublingual (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.
The grant was awarded under the Foundation's The Edmond J. Safra Core Programs for Parkinson's Research, Clinical Intervention Award, aimed at supporting human clinical trials testing promising Parkinson's therapies that may significantly and fundamentally improve treatment for people with Parkinson's.
"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," says Maurizio Facheris, MD, MSc, Associate Director of Research Programs at MJFF.
Facheris continued, "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."
"We are grateful to The Michael J. Fox Foundation, as well as their internal and external reviewers, for having judged our APL-130277 project to be worthy of support," said Mr. Anthony Giovinazzo, President and Chief Executive Officer of Cynapsus.
Mr. Giovinazzo "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."
Dr. Albert Agro, the Principal Investigator for the study and the Chief Medical Officer of Cynapsus added: "The Foundation's support with this pre-bioequivalence clinical study will be instrumental in helping us complete the requirements recommended by the US FDA in our Pre-IND meeting. We have confidence that our sublingual film strip will succeed in achieving a pharmacokinetic profile that will satisfy requirements of the US FDA's 505(b)2 approval process and lead to a timely NDA submission sometime in 2014."