12th Sep 2007 07:02
AGI Therapeutics plc12 September 2007 FDA accepts IND filing for arverapamil (AGI-003) Phase III programme Dublin, Ireland, Wednesday 12th September 2007 - AGI Therapeutics plc ("AGI" orthe "Company") (AIM, IEX: AGI), a speciality pharmaceutical company focused ongastrointestinal drug products, today announces that the US Food and DrugAdministration (FDA) has accepted its Investigational New Drug (IND) filing forarverapamil (AGI-003), AGI's treatment for diarrhoea-predominant irritable bowelsyndrome (IBS-D). Based on the FDA's review and comments on the IND, nosignificant changes are required to the pivotal Phase III study designs and AGIremains on track to initiate two of these studies this year. In April, the Company reported on its pre-IND meeting with FDA. Subsequently AGIprepared and filed the IND in June which contained details of the planned PhaseIII programme design, encompassing three pivotal Phase III studies in total. TheIND also included the full protocols for two of these studies; ARDIS-1 (apivotal Phase III efficacy/safety study) and ARDIS-3 (an open-label safetystudy) to evaluate arverapamil in IBS-D, both of which will now be initiated byAGI. Details of the design of both these trials are set out in the Notes toEditors. Commenting, Dr. John Devane, CEO, said "Advancing a product into Phase III is a major milestone for any pharmaceuticalcompany and we are very pleased to have now progressed arverapamil to thisstage. ARDIS represents an extensive clinical programme, in terms of patientnumbers and duration of treatment, required to establish the efficacy and safetyof this product in IBS-D patients, a large patient population for whom noefficacious and well-tolerated treatment exists today. We are already well-advanced in managing and co-ordinating all the activitiesrequired to initiate patient enrolment and dosing in ARDIS-1 and in preparingfor ARDIS-3 which will follow-on. In the coming months, we expect to providefurther updates on the progress of the ARDIS programme. " Contact Information: AGI Therapeutics plc. Tel: +353 1 449 3254David Kelly, Chief Financial Officer Financial Dynamics - UK Tel: +44 (0) 20 7269 7182Deborah Scott/Lara Mott Financial Dynamics - Ireland Tel: +353 1 663 3607Aisling Garvey Notes to Editors: About Arverapamil (AGI-003) Arverapamil (AGI-003) is an orally administered triple-action intestinalregulator, a first-in-class mechanism for the treatment of IBS-D. Arverapamil isa single enantiomer moiety of the racemic drug verapamil. Unlike the currentlyavailable commercial forms of racemic verapamil (a mixture of two enantiomers),arverapamil shows a dominant activity in treating the symptoms of IBS-D withoutthe traditional cardiovascular actions of the racemic drug. The efficacy andsafety of arverapamil in IBS patients has already been established in a Phase IItrial, the preliminary results of which were reported by the Company in 2006.The final results of this study will be presented by the Principal Investigator,Professor Eamonn Quigley on October 17th, 2007 at the American College ofGastroenterology's 72nd Annual Scientific Meeting to be held in Philadelphia,PA, USA. About ARDIS ARDIS represents AGI's Phase III programme for arverapamil (AGI-003) in thetreatment of IBS-D and consists of three pivotal studies. ARDIS-1 is a randomised, double-blind, placebo-controlled, parallel group, PhaseIII study in IBS-D patients (both men and women). There are four treatment arms(placebo and three dose levels of arverapamil) and patients will be treated for12 weeks of double-blind therapy. At the end of double-blind therapy in ARDIS-1,patients will become eligible to enrol into ARDIS-3. It is planned to randomise1,200 patients into ARDIS-1. ARDIS-2 is a confirmatory Phase III efficacy/safety study to be conducted inIBS-D patients upon completion of ARDIS-1. ARDIS-3 is an open-label safety study designed to capture 1 year extended safetyin approximately 100 patients on continuous arverapamil therapy. About IBS-D Irritable bowel syndrome (IBS) is a functional disorder that comprises a clusterof gastrointestinal symptoms which are likely to be life long and which affectbetween 10% and 20% of the population in developed markets. IBS remains themost common diagnosis made by gastroenterologists and can lead to a substantialreduction in patients' quality of life, accompanied by considerablesocio-economic and psychological consequences. Altered intestinal motility is amajor component of IBS and patients are diagnosed and sub-typed according totheir predominant symptom of bowel disturbance. Diarrhoea-predominant irritablebowel syndrome (IBS-D) is estimated to occur in one-third of all IBS patients.IBS-D represents a significant unmet medical need as there are currently few orno safe and effective therapeutic options available to these patients. About AGI Therapeutics plc AGI is a speciality pharmaceutical company which is focused on the developmentand commercialisation of differentiated drug products for gastrointestinal (GI)diseases and disorders. AGI's common shares are listed on the AlternativeInvestment Market of the London Stock Exchange (AIM) and on the Irish EnterpriseExchange of the Irish Stock Market (IEX) as AGI. The Company has a portfolio of product candidates derived from its KnownMolecular Entity (KME) approach to drug re-profiling and development. KME is are-profiling methodology used by the Company to identify existing therapeuticdrugs which typically have been marketed for a number of years, have establishedsafety profiles and can be developed for new clinical indications or withimproved profiles in their existing clinical indications. In this way, theCompany seeks to reduce the risk, time and cost of new product development ascompared to the development of new chemical entities. AGI is developing a range of product candidates to treat a variety of prevalentGI diseases and disorders, including irritable bowel syndrome (IBS), dyspepsia,gastroparesis, ulcerative colitis, gastro-esophageal reflux disease (GERD) anddiarrhoea-related conditions such as chemotherapy-induced diarrhoea (CID). TheCompany is targeting areas of the GI therapeutic drug products market for itsproduct candidates where there are currently unmet medical needs or where theeffectiveness of existing drug therapies can be further improved. The Company has five active clinical stage product candidates which are eitherisomers or new drug delivery formulations of existing approved drugs, and whichhave established safety and tolerability profiles in their currently approvedclinical indications. For further information please see www.agitherapeutics.com Statements contained within this press release may contain forward-lookingcomments which involve risks and uncertainties that may cause actual results tovary from those contained in the forward-looking statements. In some cases, youcan identify such forward-looking statements by terminology such as 'may', 'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes', 'estimates', 'predicts', 'potential', or 'continue'. Predictions andforward-looking references in this press release are subject to the satisfactoryprogress of research which is, by nature, unpredictable. Forward projectionsreflect management's best estimates based on information available at the timeof issue. This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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