AGI Therapeutics plc Announces Research Update

DUBLIN, IRELAND--(Marketwire - January 20, 2009) -

 AGI Therapeutics AGI completes patient enrolment in first RezularTM pivotal Phase III study - On target to report top-line results by end Q2 - Dublin, Ireland, 20 January 2009 - AGI Therapeutics plc (“AGI” or the"Company”) (AIM, IEX: AGI), a speciality pharmaceutical development company focused on gastrointestinal drug products, today announces the completion of patient enrolment for ARDIS 1, the first pivotal Phase III efficacy study of RezularTM. RezularTM is AGI’s lead product for the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D), a chronic, debilitating condition that affects millions of people. A total of 711 patients have been randomised in 123 clinical centres in the United States, Europe and South America for ARDIS 1. This study is the first of two ongoing Phase III studies which will be included in a future New Drug Application (NDA) submission to the Food and Drug Administration (FDA) for approval of RezularTM in the U.S. Of the total patients randomised, 63% are in the United States. The gender breakdown of enrolled patients is 69% female and 31% male, which closely reflects the gender ratio in the general IBS population. Top-line results of this study are on track to be reported by the end of the second quarter of 2009. The primary endpoint is patient global relief of IBS symptoms, as agreed with the FDA. Dr John Devane, CEO of AGI, commented:"The completion of enrolment in this pivotal Phase III efficacy study is a significant milestone for AGI. Recruitment for a further Phase III study designed to assess extended safety of RezularTM in IBS-D patients is also on track. The treatment of IBS-D is a major unmet medical need with no significant safe and effective therapy generally available. RezularTM is the most advanced programme in development for the treatment of IBS-D, and is well positioned to become a significant new therapy in the US market. 2009 promises to be a momentous year for our company and we look forward to delivering on our objective of progressing RezularTM to approval.” 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 (AGI-003) is an orally administered multiple mechanism intestinal regulator, a first-in-class mechanism for the treatment of IBS-D. 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 shows a dominant activity in treating the symptoms of IBS-D without the traditional cardiovascular actions of the racemic drug. The efficacy and safety of RezularTM in IBS patients has already been established in a Phase II trial, the preliminary results of which were reported by the Company in 2006. ARDIS is the Phase III programme agreed with FDA for RezularTM in the treatment of IBS-D. ARDIS 1 is a randomised, double-blind, placebo-controlled, parallel group, Phase III study in IBS-D patients (both men and women). There are four treatment arms (placebo and three dose levels of RezularTM) and patients will be treated for 12 weeks of double-blind therapy. In July 2008, the Company announced that the US FDA agreed the statistical approach to be used to analyse the ARDIS 1 study data, and also re-affirmed the previously agreed key parameters of the RezularTM Phase III programme, and in particular the acceptability of the current primary endpoint of patient-reported global relief of IBS symptoms. ARDIS 3 is an ongoing open-label safety study designed to capture 1 year extended safety in 100 IBS-D patients on continuous RezularTM therapy -- Ends -- Contact Information: AGI Therapeutics plc. Tel: +353 1 449 3254 David Kelly, Chief Financial Officer Financial Dynamics - UK Tel: +44 (0) 20 7269 7182 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 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. The Company has a portfolio of product candidates derived from its Known Molecular Entity (KMETM) approach to drug re-profiling and development. The Company’s lead product candidate, RezularTM, is an orally administered multiple mechanism intestinal regulator, a first-in-class mechanism for the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D). KME is a re-profiling methodology used by the Company to identify existing therapeutic drugs which typically have been marketed for a number of years, have established safety profiles and can be developed for new clinical indications or with improved profiles in their existing clinical indications. In this way, the Company seeks to reduce the risk, time and cost of new product development as compared to the development of new chemical entities. 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 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