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The trial, a multi-centre, randomised, double-blind, placebo controlled,parallel group exploratory study, investigated the efficacy, safety andtolerability of AD 337 in the treatment of fibromyalgia in female subjects.In total, the trial enrolled 103 patients across 18 centres in the UK andAustralia with the primary study endpoint being the difference in theFibromyalgia Impact Questionnaire (FIQ) score, between active and placebo,after 4 weeks of treatment.
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Results show that the study did not achieve a statistically significantoutcome in its primary endpoint at 4 weeks. However statistical significancein FIQ was achieved at the 1 week time point and positive trends were seenthroughout the study. In addition statistically significant measures in otherefficacy assessments such as the Short Form McGill Pain Questionnaire and theFibromyalgia Health Assessment Questionnaire (FHAQ) were seen at early timepoints. On balance it is concluded that AD 337 has some potential in thetreatment of fibromyalgia syndrome.
AD 337 was well tolerated and there were no clinically significantchanges in vital signs, biochemistry, haematology and cardiovascularparameters.
Commenting on these results Shinichi Tamura, CEO, said "This proof ofprinciple study with an unoptimised formulation and dosing schedule andlimited to four weeks in duration has demonstrated a degree of activity.Sosei will be evaluating these results to determine its approach to thepossible further development of AD 337 in FMS and other potentialindications."
Notes to Editors:
About Sosei
Sosei Group Corporation is a leading international biopharmaceuticalcompany with significant expertise in product discovery and development. Ithas established a reduced risk business model primarily upon identifying newuses for established drugs and exploiting its unique position withinJapanese, European and North American pharmaceutical markets by acquiringcompounds from, and bringing compounds into, Japan.
For further information about Sosei, please visit http://www.sosei.com.
About Fibromyalgia
Fibromyalgia syndrome predominantly affects women between the ages of 35and 60 with an estimated prevalence of 2% in the USA. The disease ischaracterised by widespread musculoskeletal pain that presents with a numberof co-morbidities including fatigue, sleep disturbance and depression. Theaetiology of the syndrome is not well understood but serotonin (5-HT) andnoradrenalin (NA) dysfunction is believed to be a contributory factor. Todate only one drug, Lyrica (pregabalin) is specifically indicated for FMS andapproval in the USA was only granted in June 2007. Accordingly, therapycontinues to be based on a variety of treatments used to deal with variousfibromyalgia symptoms.
The global market for such treatments is currently worth some $350m andis expected to grow to around $1.7 billion in the next 10 years as furthernew therapeutic options specifically indicated for fibromyalgia becomeavailable.
SOURCE Sosei Group Corporation
