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Synosia Announces Encouraging Results of Proof-of-Concept Clinical Trial for Epilepsy Drug rufinamide as a Treatment for Mood Disorders
Date:1/22/2008

Speed in Reaching First Clinical Milestone Validates Approach

SAN FRANCISCO, January 22 /PRNewswire/ -- Synosia Therapeutics today announced the successful completion of its first clinical trial, a proof-of-concept study that evaluated new therapeutic options for SYN-111 (rufinamide), a sodium channel blocker. Rufinamide was discovered and developed by Novartis and is currently marketed by Eisai in Europe as a drug to treat a form of epilepsy. This first trial was completed in less than seven months from design to final dosing and less than a year after the rights to rufinamide in mood disorders were obtained from Novartis in an exclusive licensing agreement.

The placebo-controlled, double-blind, three-dose study measured drug effect and pattern of response using quantitative electroencephalography (EEG) in healthy volunteers, who all received each dose plus placebo. After each dose, the subject's brain waves were evaluated over the course of 24 hours, noting quantitative change in each wave and the pattern of the change as an indication of rufinamide activity. The study was conducted in France.

"The data from this study lend support to observations in animal behaviour models and further justify investigation of the effect of rufinamide for mood disorders," said Stephen Bandak, Synosia's Chief Medical Officer. "The study has also helped us select a dose for our Phase 2 trial in general anxiety disorder scheduled to start in the United States later this year."

Rights to SYN111 were obtained by Synosia from Novartis in 2007 in an exclusive worldwide (outside of Japan) licensing agreement to develop and commercialise rufinamide for the treatment of anxiety and other mood disorders. It is estimated that over 62 million people in the United States and the five major European pharmaceutical markets suffer from a form of anxiety. Of those, over nine million suffer from general anxiety disorder.(1, 2)

"Our development approach of identifying and licensing clinically enabled compounds like rufinamide allows Synosia to quickly move into smart, efficient clinical trials designed to rapidly establish proof of concept in new therapeutic areas," said Synosia Chief Executive Officer and President Ian Massey. "Rufinamide, a structurally novel compound with proven efficacy in epilepsy and with an extensive safety database, was a perfect candidate to demonstrate the soundness of our strategy. The impressive speed in which this trial was designed, executed and completed is a real highlight for us."

About Rufinamide

The drug was originally discovered and developed by Novartis, which granted certain licensing rights to Eisai of Japan in 2004. In January 2007, Eisai received marketing authorisation in the European Union for Inovelon(R) (rufinamide) as adjunctive anti-epileptic therapy in Lennox-Gastaut Syndrome (LGS), a severe form of epilepsy that develops in early childhood. Eisai has also submitted an NDA for rufinamide to the US Food and Drug Administration (FDA) for adjunctive therapy in adults and adolescents. The extensive clinical development program for rufinamide in epilepsy has generated over 2500 patient-years of exposure to the drug.

About Synosia Therapeutics

Synosia Therapeutics develops and intends to commercialise innovative and clinically differentiated products for unmet medical needs in psychiatry and neurology. The privately-owned company is developing six clinical-stage compounds acquired through key partnerships with Novartis, Roche and Syngenta, including two marketed drugs that will be tested in new indications, extending their reach into new therapeutic areas with combined sales potential in excess of US$2.5 billion. Synosia has offices in Basel, Switzerland, and South San Francisco, CA.

Synosia Therapeutics has raised US$32.5 million funding from Versant Ventures (Menlo Park, CA), Abingworth Management (London), 5AM Ventures (Menlo Park, CA) and Novo A/S (Copenhagen, Denmark). For more information, visit http://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. Demyttenaere et al. Prevalence, Severity, and unmet needs for treatment of mental disorders in the WHO World Mental Surveys. JAMA (2004) vol. 291 (21) pp. 2581-90.

2. Kessler et al. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry (2005) vol. 62 (6) pp. 593-602.


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