The phase IIa trial was a randomised, double-blind, placebo-controlled, cross-over study in 24 parkinson’s patients using doses up to 120mg/day for one week. The effects of SYN-115 as an add-on therapy to a stable dose of levodopa was assessed using a number of techniques, including functional magnetic resonance imaging (fMRI), clinical ratings such as the Unified Parkinson’s Disease Rating Scale and various cognitive tests.
The data from fMRI using arterial spin labelling showed that SYN-115 produced dose-related changes in blood flow in regions of the brain, known to be relevant to parkinson’s.
The company said that further positive results on multiple clinical endpoints of motor and non-motor symptoms of parkinson’s disease will be announced in the coming months.
Dr Kevin Black, principal investigator and associate professor of psychiatry, neurology, radiology and neurobiology at the Washington University School of Medicine in St Louis, Missouri, said: “These encouraging results suggest that SYN-115 is able to cross the blood-brain barrier and have an effect that could be beneficial to patients with parkinson’s.”
Steve Bandak, chief medical officer of Synosia, said: “The innovative, imaging techniques used have given us a great deal of information to help plan future clinical trials of SYN-115. We have successfully established that SYN115 is getting into the brain, changing the activity of relevant regions of the brain, and we now have a better understanding of the doses that are likely to be therapeutically useful. Those were our objectives in undertaking the study.”