Sosei Drug Misses Goal in Fibromyalgia Trial
TOKYO, September 18 -- Sosei Group Corporation , 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."
Notes to Editors:
Sosei Group Corporation is a leading international biopharmaceutical company with significant expertise in product discovery and development. It has established a reduced risk business model primarily upon identifying new uses for established drugs and exploiting its unique position within Japanese, European and North American pharmaceutical markets by acquiring compounds from, and bringing compounds into, Japan.
For further information about Sosei, please visit http://www.sosei.com.
Fibromyalgia syndrome predominantly affects women between the ages of 35 and 60 with an estimated prevalence of 2% in the USA. The disease is characterised by widespread musculoskeletal pain that presents with a number of co-morbidities including fatigue, sleep disturbance and depression. The aetiology of the syndrome is not well understood but serotonin (5-HT) and noradrenalin (NA) dysfunction is believed to be a contributory factor. To date only one drug, Lyrica (pregabalin) is specifically indicated for FMS and approval in the USA was only granted in June 2007. Accordingly, therapy continues to be based on a variety of treatments used to deal with various fibromyalgia symptoms.
The global market for such treatments is currently worth some $350m and is expected to grow to around $1.7 billion in the next 10 years as further new therapeutic options specifically indicated for fibromyalgia become available.