Press Releases

Synosia Begins Phase IIa Trial For Potential First-in-Class
Treatment for Parkinson’s Disease

Basel, Switzerland, June 3rd, 2008 – Synosia Therapeutics today announced the start of a Phase IIa clinical trial to evaluate the efficacy and safety of an A2a antagonist (SYN-115) as a
new approach to the treatment of Parkinson’s disease.

SYN-115 is a potent and selective third-generation inhibitor of the A2a receptor, which modulates dopaminergic and glutamatergic transmission in specific regions of the brain. SYN-115 has demonstrated robust activity in preclinical models of Parkinson’s disease and also shows potential to improve non-motor symptoms of Parkinson’s such as cognition, anxiety and mood.

The clinical trial, being conducted at Washington University School of Medicine in St. Louis, Missouri, is a randomized, double-blind, placebo-controlled study in up to 32 Parkinson’s patients at doses up to 120mg/day for one week and is being led by principal investigator Kevin J. Black, M.D., Associate Professor of Psychiatry, Neurology, Radiology and Neurobiology.

The effects of SYN-115 as an add-on therapy to a stable dose of levodopa will be assessed using a number of techniques including functional Magnetic Resonance Imaging, clinical ratings such as the Unified Parkinson’s Disease Rating Scale and various cognitive tests. Results will form the basis of a larger Phase IIb study planned for early 2009.

“This is a proof-of-mechanism trial using traditional clinical ratings but also innovative imaging techniques, which will give us crucial information about how the drug is working,” said Stephen Bandak, Synosia’s chief medical officer. “We already know a great deal about SYN-115, thanks to previous preclinical and clinical studies conducted by Roche, and we believe it has real potential to offer therapeutic benefits for patients over and above current leading treatments.”

Parkinson’s disease is a chronic and progressive, degenerative disease attributed to loss of dopamine-producing neurons. It is the second most common neurodegenerative disorder, after Alzheimer’s disease and affects about one per cent of people aged 65-69 years, rising to about three per cent for those aged 80 or over.1

About SYN-115

Rights to SYN-115 were obtained by Synosia from Roche in 2007 for development in selected indications of the central nervous system. Early clinical development by Roche, including single and multiple ascending dose and toxicology studies, indicated that SYN-115 has a good safety profile and is well tolerated.

About Synosia Therapeutics

Synosia Therapeutics develops and intends to commercialise innovative and clinically differentiated products for unmet medical needs in psychiatry and neurology. The privatelyowned company has six clinical-stage compounds in its pipeline acquired through key partnerships with Novartis, Roche and Syngenta. Two of the compounds are marketed drugs that will be tested in new indications, extending their reach into neurological and psychiatric diseases with high unmet medical need, including anxiety and Parkinson’s disease. Synosia’s headquarters is in Basel, Switzerland. For more information visit www.synosia.com

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements concerning Synosia Therapeutics and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Synosia Therapeutics to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.

Synosia Therapeutics is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

References

  1. Guttmacher et al. Alzheimer’s Disease and Parkinson’s Disease. New England Journal of Medicine (2003); 348; 1356-64


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