Sep 29 2010
Synosia Therapeutics today announced the first clinical study results showing that SYN-118 provides clinically meaningful benefits to Parkinson's patients, has a good safety profile and is well tolerated. Results from an open-label, proof-of-mechanism study of SYN-118 (CL02) were presented at the World Parkinson Congress in Glasgow, Scotland.
“As we anticipated, the clinical results of this study confirm that SYN-118 produces stable increases in dopamine in the areas of the brain relevant to Parkinson's and results in an improvement in motor symptoms”
The trial at the Karolinska University Hospital in Stockholm tested safety, efficacy and pharmacodynamic effects by giving SYN-118 as an add-on therapy to advanced PD patients' current medications.
At the end of the 28-day trial, patients treated with SYN-118 showed a statistically significant improvement in motor symptoms compared with baseline scores, as measured by the Unified Parkinson's Disease Rating Scale (UPDRS) item III (motor function). In addition, SYN-118 generated a statistically significant signal by positron emission tomography (PET) imaging in brain regions relevant to PD.
"As we anticipated, the clinical results of this study confirm that SYN-118 produces stable increases in dopamine in the areas of the brain relevant to Parkinson's and results in an improvement in motor symptoms," said Stephen Bandak, Synosia's Chief Medical Officer.
"These encouraging efficacy and safety results provide a strong rationale to move forward our clinical programme for SYN-118," said Ian Massey, Synosia's Chief Executive Officer. "In addition, the successful completion of this innovative study, including imaging techniques, reinforces the value of Synosia's approach of using smart, efficient proof-of-concept studies to inform the start of extensive Phase II trials of promising compounds."
Based on these proof-of-mechanism results, Synosia started a randomised, placebo-controlled Phase II study using SYN-118 in Parkinson's disease patients in the final quarter of 2009.
SOURCE Synosia Therapeutics