Biotie will receive US$2m, while Cynapsus grant is $500,000
Biotie Therapies, a Finnish biotechnology and pharmaceutics company, has signed a US$2m research contract with The Michael J. Fox Foundation (MJFF) to investigate SYN120 in Parkinson's disease patients with dementia.
Meanwhile, MJFF has awarded Cynapsus Therapeutics, a specialist pharmaceutical company based in Toronto, Canada, $500,000 to support clinical studies to develop APL-130277, a sublingual thin film strip reformulation of apomorphine for treating Parkinson's disease. This is the company's second MJFF grant and will be used to fund Cynapsus Therapeutics' CTH-105 clinical study.
For Biotie Therapies, MJFF will fund an 80 patient, Phase IIa, randomised, double-blind, placebo-controlled SYN120 trial of 16 weeks duration in patients with Parkinson's disease dementia.
SYN120 is a dual antagonist of 5-HT6 and 5-HT2a receptors and these two modes of action could result in a unique therapeutic profile for SYN120 combining pro-cognitive and antipsychotic activities.
In addition to assessing safety and tolerability, the main focus of the trial will be to establish efficacy of SYN120 on cognition using the Cognitive Drug Research (CDR) Computerised Cognition Battery as the primary efficacy endpoint.
This trial, which should start in the second half of this year, will be conducted by the Parkinson Study Group (PSG) at approximately 10 US sites specialising in cognitive dysfunction in Parkinson's disease. Biotie and the PSG will share responsibility to design and execute this study.
Biotie retains the rights to SYN120 and will be able to use data from the MJFF-funded study for any future regulatory submission.
Cynapsus' APL-130277 is a fast-acting and proprietary reformulation of apomorphine for sublingual delivery. Injectable apomorphine is the only approved drug in the US, Europe, Japan and other countries for the acute rescue of 'off' motor symptoms of Parkinson's disease.
CTH-105 is a pilot study in patients with Parkinson's disease who are naïve to the use of apomorphine and who experience at least one daily 'off' episode with a total duration of 'off' in any 24-hour period of at least two hours.
The MJFF previously awarded Cynapsus a grant of almost $948,000 to complete a comparative study of APL-130277.
As part of the MJFF grant agreement, Cynapsus has made a commitment to support further Parkinson's research by making up to $1m in contributions to MJFF based on future potential sales of APL-130277.