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 statistically significant, dose-related changes in blood flow in regions of the brain known to be relevant to Parkinson’s. Activity in these regions is known to be modulated by established Parkinson’s treatments such as dopamine agonists and levodopa.
Further positive results on multiple clinical endpoints of motor and non-motor symptoms of Parkinson’s disease will be announced in the coming months.
Principal investigator Dr Kevin Black, 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.”
“The innovative, imaging techniques used have given us a great deal of information to help plan future clinical trials of SYN-115,” said Dr Steve Bandak, Synosia’s Chief Medical Officer. “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.”