Synosia Announces Encouraging Results of Proof-of-Concept Clinical Trial for Epilepsy Drug rufinamide as a Treatment for Mood Disorders

Tuesday, January 22, 2008 General News
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SAN FRANCISCO, January 22 Synosia Therapeutics todayannounced the successful completion of its first clinical trial, aproof-of-concept study that evaluated new therapeutic options for SYN-111(rufinamide), a sodium channel blocker. Rufinamide was discovered anddeveloped by Novartis and is currently marketed by Eisai in Europe as a drugto treat a form of epilepsy. This first trial was completed in less thanseven months from design to final dosing and less than a year after therights to rufinamide in mood disorders were obtained from Novartis in anexclusive licensing agreement.

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

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

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

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

About Rufinamide

The drug was originally discovered and developed by Novartis, whichgranted 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 hasalso submitted an NDA for rufinamide to the US Food and Drug Administration(FDA) for adjunctive therapy in adults and adolescents. The extensiveclinical development program for rufinamide in epilepsy has generated over2500 patient-years of exposure to the drug.

About Synosia Therapeutics

Synosia Therapeutics develops and intends to commercialise innovative andclinically differentiated products for unmet medical needs in psychiatry andneurology. The privately-owned company is developing six clinical-stagecompounds acquired through key partnerships with Novartis, Roche andSyngenta, including two marketed drugs that will be tested in newindications, extending their reach into new therapeutic areas with combinedsales 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 VersantVentures (Menlo Park, CA), Abingworth Management (London), 5AM Ventures(Menlo Park, CA) and Novo A/S (Copenhagen, Denmark). For more information,visit http

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