AGI Therapeutics plc: Top-line results of Phase III study of Rezular

DUBLIN, IRELAND--(Marketwire - May 15, 2009) -

 AGI Therapeutics Announces top-line results of Phase III study of RezularTM in IBS-D Dublin, Ireland, 15 May 2009 - AGI Therapeutics plc (“AGI” or the"Company”) (AIM, IEX: AGI), a speciality pharmaceutical development company focused on gastrointestinal drug products, today announces top-line results from it’s Phase III clinical study, ARDIS 1, of RezularTM, in diarrhoea-predominant Irritable Bowel Syndrome (IBS-D). - The study did not show statistically significant differences between treatments in the primary endpoint of patient reported adequate relief of IBS symptoms - Statistically significant evidence favouring Rezular treatment was achieved in a number of secondary endpoints, particularly those relating to aspects of diarrhoea (e.g. stool form as assessed by the Bristol Stool Scale), stool frequency and in the majority of sub-categories of quality-of-life (IBS-QOL) scores and in the overall IBS-QOL score - There were no statistically significant differences between treatments in adequate relief of pain/discomfort or change in severity of pain - Based on this preliminary data analysis, AGI does not believe that Rezular will meet the regulatory requirements for an effective therapy for the broad IBS-D population and plans to cease its development in this indication. ARDIS 1 was a randomised, double-blind, placebo-controlled, parallel group, Phase III study in IBS-D patients (both men and women). There were four treatment arms (placebo and three dose levels of RezularTM) and patients were treated for 12 weeks of double-blind therapy. A total of 711 patients were randomised in 123 clinical centres in the United States, Europe and South America. Of the total patients randomised, 63% were in the United States. Dr John Devane, CEO of AGI, commented:"A safe and effective therapy for patients with IBS-D remains elusive. We are very disappointed that this study did not achieve its primary clinical endpoint. While we saw evidence that RezularTM has activity in many aspects of this multi-symptom disease, as in our earlier study, our experience in bringing products to market suggests to us that the pursuit of this product as a therapy for IBS-D would not be a prudent use of our resources. AGI has a promising portfolio of other products. Recently we announced positive proof-of-concept Phase II results for AGI004 in the treatment of chemotherapy-induced diarrhoea (CID) in cancer patients. We will now focus our efforts on prioritising our pipeline and plan how best to move these forward. We will keep our shareholders apprised of these plans.” Conference Call: Please note that AGI will hold a conference call to discuss these results today, beginning at 09:30 BST. To participate, please call +353 1 486 0922 (Ireland) or +44 (0) 20 7806 1951 (UK) quoting the confirmation code 7142383. A slide presentation accompanying this call will be available in the Investors/ Publications section of the AGI website 15 minutes before the call commences, or by following this link: http://phx.corporate-ir.net/ phoenix.zhtml?c=196905&p=irol-reports -- Ends -- Contact Information: AGI Therapeutics plc. Tel: +353 1 449 3254 David Kelly, Chief Financial Officer Financial Dynamics - UK Tel: +44 (0) 20 7269 7205 Jonathan Birt/John Dineen Financial Dynamics - Ireland Tel: +353 1 663 3602 Niamh Lyons Piper Jaffray Limited Tel: +44 (0) 20 3142 8700 Neil Mackison Will Carnwath Davy Tel: +353 1 614 8761 John Frain For further information please see www.agitherapeutics.com. Notes to Editors: About IBS-D and RezularTM Irritable bowel syndrome comprises a cluster of gastrointestinal symptoms which are likely to be life-long and which affect between 10% and 20% of the population in developed markets. IBS remains one of the most common diagnoses made by gastroenterologists and can lead to a substantial reduction in patients’ quality of life, accompanied by considerable socio-economic and psychological consequences. Altered intestinal motility is a major component of IBS and patients are diagnosed and sub-typed according to their predominant symptom of bowel disturbance. IBS-D is estimated to occur in one-third of all IBS patients, and represents a significant unmet medical need, as there are currently few safe and effective therapeutic options available to these patients. RezularTM contains arverapamil, a single enantiomer moiety of the racemic drug verapamil. Unlike the currently available commercial forms of racemic verapamil (a mixture of two enantiomers), RezularTM has shown dominant activity in the gut without the traditional cardiovascular actions of the racemic drug. The efficacy and safety of RezularTM in IBS patients was established in a Phase II trial, the preliminary results of which were reported by the Company in 2006. About AGI Therapeutics plc AGI is a speciality pharmaceutical company which is focused on the development and commercialisation of differentiated drug products for gastro-intestinal (GI) diseases and disorders. AGI’s common shares are listed on the Alternative Investment Market of the London Stock Exchange (AIM) and on the Irish Enterprise Exchange of the Irish Stock Market (IEX) as AGI. AGI is developing a range of product candidates to treat a variety of prevalent GI diseases and disorders, including irritable bowel syndrome, dyspeptic symptoms, gastroparesis, ulcerative colitis, gastro-esophageal reflux disease (GERD) and diarrhoea-related conditions such as chemotherapy-induced diarrhoea (CID). The Company is targeting areas of the GI therapeutic drug products market for its product candidates where there are currently unmet medical needs or where the effectiveness of existing drug therapies can be further improved. The Company currently has five active clinical stage product candidates which are either isomers or novel drug delivery formulations of existing approved drugs and which have established safety and tolerability profiles in their currently approved clinical indications. For further information please see www.agitherapeutics.com. Statements contained within this press release may contain forward-looking comments which involve risks and uncertainties that may cause actual results to vary from those contained in the forward-looking statements. In some cases, you can identify such forward-looking statements by terminology such as ‘may’, ‘will’,'could’, ‘forecasts’, ‘expects’, ‘plans’, ‘anticipates’, ‘believes’,'estimates’, ‘predicts’, ‘potential’, or ‘continue’. Predictions and forward-looking references in this press release are subject to the satisfactory progress of research which is, by nature, unpredictable. Forward projections reflect management’s best estimates based on information available at the time of issue. This information is provided by RNS The company news service from the London Stock Exchange END