Synosia Therapeutics today announced the presentation of data from a phase 2a clinical study of the company's adenosine 2a (A2a) receptor antagonist (SYN-115) in Parkinson's disease. The data demonstrate that SYN-115 significantly improves measures of motor and non-motor function in patients with Parkinson's disease (PD) either alone or in combination with levodopa. The results also clearly illustrate the value of perfusion magnetic resonance imaging (MRI) as a tool to rapidly evaluate the pharmacodynamic effects of new drugs in the brain. Findings will be presented today at the American Academy of Neurology 62nd Annual Meeting in Toronto, Ontario, Canada.
“The results for this study give us confidence that SYN-115 is having the anticipated and desired effects in the brain and has high potential to become an innovative medicine for the treatment of the motor and non-motor symptoms of Parkinson's disease”
"These data provide clear evidence that SYN-115 penetrates the brain and produces changes in the activity of regions known to be sensitive to drugs used to treat Parkinson's. These changes accompany significant improvements in selected measures of motor and non-motor functions in these patients," said Dr Kevin J. Black, associate professor of psychiatry, neurology, radiology and neurobiology at the Washington University School of Medicine in St. Louis, Missouri, and principal investigator for the phase 2a study. "Additionally, through the successful utilization of perfusion MRI to assess the impact of SYN-115 in specific regions of the brain, this study clearly demonstrates the utility of this technique to provide rapid, useful and clinically relevant information for the evaluation of new drugs for the treatment of CNS disorders."
The phase 2a trial was a randomized, double-blind, placebo-controlled, cross-over study in patients with mild-to-moderate Parkinson's disease. Patients were randomized to one week each of SYN-115, washout, and then matching placebo, or the reverse. Effects of 60 mg BIDs Disease Rating Scale (UPDRS), tapping speed, and cognitive tests.
The data presented today demonstrate that, after correction for whole-brain CBF effects and for multiple comparisons, SYN-115 produced highly significant, dose-responsive decreases in cerebral blood flow in regions of the brain known to be relevant to Parkinson's. These decreases are entirely consistent with the expected mechanism of action of SYN-115.
In the 60 mg cohort, tapping speed was improved (faster) by SYN-115 as compared to placebo, both before (5 percent,>
Total UPDRS motor score was 20 percent lower (improved) with SYN-115 as compared to placebo when administered with levodopa>
"The results for this study give us confidence that SYN-115 is having the anticipated and desired effects in the brain and has high potential to become an innovative medicine for the treatment of the motor and non-motor symptoms of Parkinson's disease," said Dr. Ian Massey, Synosia's chief executive officer and president. "Based on these important and exciting findings, we plan to initiate additional clinical studies to further evaluate the efficacy and safety of SYN-115."
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