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



    Speed in Reaching First Clinical Milestone Validates Approach

    SAN FRANCISCO, Jan. 22 /CNW/ - 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.





For further information:

For further information: Synosia Therapeutics: In Europe: Julie Walters
at Tudor Reilly, Tel: +44-207-016-7714, Mobile +44-775-3626967,
julie.walters@tudor-reilly.com; In US: Jane Eckels at Tudor Reilly, Tel: (415)
235-6312, jane.eckels@tudor-reilly.com

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