Press release
Sep 18, 2007

Sosei Announces Completion of Phase II Trial of AD 337 in Fibromyalgia Syndrome


Tokyo, Japan – 18 September 2007: Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), the biopharmaceutical company, today announces that AD 337, an enantiomer of an approved, centrally acting, non-opioid, analgesic, has completed a Phase II proof of principle trial for the treatment of fibromyalgia syndrome (FMS).

The trial, a multi-centre, randomised, double-blind, placebo controlled, parallel group exploratory study, investigated the efficacy, safety and tolerability of AD 337 in the treatment of fibromyalgia in female subjects. In total, the trial enrolled 103 patients across 18 centres in the UK and Australia with the primary study endpoint being the difference in the Fibromyalgia Impact Questionnaire (FIQ) score, between active and placebo, after 4 weeks of treatment.

Results show that the study did not achieve a statistically significant outcome in its primary endpoint at 4 weeks. However statistical significance in FIQ was achieved at the 1 week time point and positive trends were seen throughout the study. In addition statistically significant measures in other efficacy assessments such as the Short Form McGill Pain Questionnaire and the Fibromyalgia Health Assessment Questionnaire (FHAQ) were seen at early time points. On balance it is concluded that AD 337 has some potential in the treatment of fibromyalgia syndrome.

AD 337 was well tolerated and there were no clinically significant changes in vital signs, biochemistry, haematology and cardiovascular parameters.

Commenting on these results Shinichi Tamura, CEO, said “This proof of principle study with an unoptimised formulation and dosing schedule and limited to four weeks in duration has demonstrated a degree of activity. Sosei will be evaluating these results to determine its approach to the possible further development of AD 337 in FMS and other potential indications.”


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