Ground breaking data on Synosia’s investigational new Parkinson’s drug published in The Journal of Neuroscience

BASEL, SWITZERLAND, December 1, 2010 – New data on Synosia Therapeutics’ investigational drug SYN-115 were published today in The Journal of Neuroscience1.

The data obtained using perfusion magnetic resonance imaging (MRI) in patients with Parkinson’s disease show that SYN-115 crosses the blood-brain barrier to affect areas of the brain linked to the disease in a dose-dependent manner.

Specifically, SYN-115 inhibits the indirect pathway that is over-activated in Parkinson’s patients. SYN-115 was also shown to inhibit cortical activity in a manner consistent with improving alertness and attention. Significant improvement in measures of motor and non-motor function in patients who participated in this study has been previously presented at the annual meetings of the Society for Neuroscience and the American Academy of Neurology.2,3

The results are believed to be the first time that perfusion MRI has been applied to an investigational new drug in humans to successfully measure pharmacodynamic response.

“These results are significant for two reasons,” said Dr Stephen Bandak, Synosia’s Chief Medical Officer. “Firstly, they show that SYN-115 enters the brain and exerts dose-dependent effects in regions that we know are important to Parkinson’s and, secondly, that perfusion MRI can provide rapid, quantitative and clinically relevant dose-finding pharmacodynamic information for pharmaceutical development.”

The phase IIa trial was a randomized, double-blind, placebo-controlled, crossover study in 21 patients with mild to moderate Parkinson’s disease on levodopa. The study was conducted at the Center for Clinical Imaging Research and the NeuroClinical Research Unit of Washington University School of Medicine, St Louis, Missouri.

Patients participating in the study received SYN-115 and placebo twice daily each for one week with a one-week washout period in between. Perfusion MRI and clinical assessment was performed at the end of each treatment period.

The findings will inform a phase IIb trial of SYN-115 in Parkinson’s patients, due to begin in 2011.

About SYN-115

SYN-115 is an orally-bioavailable potent and selective adenosine 2A (A2a) antagonist, which enters the brain and activates regions associated with motor and non-motor function. Synosia obtained rights to SYN-115 from Roche (SIX: RO, ROG; OTCQX: RHHBY) in 2007 for development and commercialisation in selected indications of the central nervous system and has an option to rights for development in all indications. SYN-115 is currently in phase II.

In October this year, Synosia granted exclusive worldwide rights for development and commercialisation of SYN-115 to UCB. UCB will be responsible for phase III development and commercialisation.

About Parkinson’s disease

Parkinson’s disease is the second most common neurodegenerative disorder, after Alzheimer’s disease. It affects about one percent of people ages 65-69, rising to up to three percent of people who are 80 years and older.4 Parkinson’s disease manifestations result from decreased dopamine production in the brain. Dopamine is a neurotransmitter that plays an important role in muscle control.

About Synosia

Synosia Therapeutics is a privately owned company, which develops and intends to commercialise innovative, first or best-in-class products for unmet medical needs in neurology and psychiatry. Synosia utilises cutting-edge technologies and creative clinical study designs to de-risk its compounds before moving into larger, more extensive phase II and phase III programmes.

Synosia has six clinical-stage compounds in its pipeline for neurological and psychiatric diseases with high unmet medical need, including Parkinson’s and Alzheimer’s disease. Synosia is headquartered in Basel, Switzerland.  For more information visit www.synosia.com

References

1. Black et al. Quantification of Indirect Pathway Inhibition by the Adenosine A2a Antagonist SYN115 in Parkinson Disease. The Journal of Neuroscience (2010); 48; 16284
2. Dickerson et al. The Adenosine 2a antagonist SYN115 decreases thalamic rCBF in Parkinson’s disease. Soc Neurosci Abstr 35:504.2. (2009)
3. Black et al. A randomized double-blind, placebo-controlled cross-over trial of the adenosine 2a antagonist SYN115 in Parkinson’s disease. Neurology 74 [Suppl 2]:A317 (2010)
4. Guttmacher et al. Alzheimer’s Disease and Parkinson’s Disease. New England Journal of Medicine (2003); 348; 1356-64

Disclaimer

This communication, and oral statements made with respect to information contained in this communication, expressly or implicitly contains certain forward-looking statements concerning Synosia Therapeutics and its business. Such forward-looking statements include those which express plans, anticipation, intent, contingency, goals, targets or future development and/or otherwise are not statements of historical fact including, but not limited to our plans for our regulatory filings, enrolment and future plans for our clinical trials, progress of and reports of results from clinical studies, clinical development plans and product development activities. The words “potential”, “could” and similar expressions also identify forward-looking statements. These statements are based upon management's current expectations and are subject to risks and uncertainties, known and unknown, which could cause actual results and developments to differ materially from those expressed or implied in such statements. Factors that could affect actual results include risks associated with the possibility that the respective regulatory agencies refuse approval of our applications, the outcome of any discussions with such regulatory agencies and unexpected delays in preparation of materials for submission to such respective regulatory agencies as a part of our filings.

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. Actual events could differ materially from those anticipated in the forward-looking statements.

Rachel Penniston
Account Executive
Tudor Reilly
 
Tel: +44 (0) 20 7034 7074
Dir: +44 (0) 20 7034 7607
Fax: +44 (0) 20 7034 7100
E-mail: rachel.penniston@tudor-reilly.com

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