FDA accepts IND filing for arverapamil (AGI-003) Phase III programme
Dublin, Ireland, 12th September 2007: AGI Therapeutics plc ("AGI" or the "Company") (AIM, IEX: AGI), a speciality pharmaceutical company focused on gastrointestinal drug products, today announces that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) filing for arverapamil (AGI-003), AGI's treatment for diarrhoea-predominant irritable bowel syndrome (IBS-D). Based on the FDA's review and comments on the IND, no significant changes are required to the pivotal Phase III study designs and AGI remains on track to initiate two of these studies this year.
In April, the Company reported on its pre-IND meeting with FDA. Subsequently AGI prepared and filed the IND in June which contained details of the planned Phase III programme design, encompassing three pivotal Phase III studies in total. The IND also included the full protocols for two of these studies; ARDIS-1 (a pivotal Phase III efficacy/safety study) and ARDIS-3 (an open-label safety study) to evaluate arverapamil in IBS-D, both of which will now be initiated by AGI. Details of the design of both these trials are set out in the Notes to Editors.
Commenting, Dr. John Devane, CEO, said
"Advancing a product into Phase III is a major milestone for any pharmaceutical company and we are very pleased to have now progressed arverapamil to this stage. ARDIS represents an extensive clinical programme, in terms of patient numbers and duration of treatment, required to establish the efficacy and safety of this product in IBS-D patients, a large patient population for whom no efficacious and well-tolerated treatment exists today.
We are already well-advanced in managing and co-ordinating all the activities required to initiate patient enrolment and dosing in ARDIS-1 and in preparing for ARDIS-3 which will follow-on. In the coming months, we expect to provide further updates on the progress of the ARDIS programme."
For further information please contact:
AGI Therapeutics
David Kelly, Chief Financial Officer
Tel: +353 1 449 3254
Financial Dynamics - UK
Sarah MacLeod
Tel: +44 (0) 20 7831 3113
Financial Dynamics - Ireland
Aisling Garvey
Tel: +353 1 663 3607
Notes to Editors:
About Arverapamil (AGI-003)
Arverapamil (AGI-003) is an orally administered triple-action intestinal regulator, a first-in-class mechanism for the treatment of IBS-D. Arverapamil is a single enantiomer moiety of the racemic drug verapamil. Unlike the currently available commercial forms of racemic verapamil (a mixture of two enantiomers), arverapamil 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 arverapamil in IBS patients has already been established in a Phase II trial, 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 of Gastroenterology's 72nd Annual Scientific Meeting to be held in Philadelphia, PA, USA.
About ARDIS<br />
ARDIS represents AGI's Phase III programme for arverapamil (AGI-003) in the treatment of IBS-D and consists of three pivotal studies.
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 arverapamil) and patients will be treated for 12 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 randomise 1,200 patients into ARDIS-1.
ARDIS-2 is a confirmatory Phase III efficacy/safety study to be conducted in IBS-D patients upon completion of ARDIS-1.
ARDIS-3 is an open-label safety study designed to capture 1 year extended safety in approximately 100 patients on continuous arverapamil therapy.
About IBS-D
Irritable bowel syndrome (IBS) is a functional disorder that 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 the most common diagnosis 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. Diarrhoea-predominant irritable bowel 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 or no safe and effective therapeutic options available to these patients.
About AGI<br />
AGI is a speciality pharmaceutical company which is focused on the development and commercialisation of differentiated drug products for gastrointestinal ("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 the Known Molecular Entity ("KME") approach to drug re-profiling and development. 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, functional dyspepsia, ulcerative colitis and gastro-esophageal reflux disease. 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 six clinical stage product candidates which are either isomers or new drug delivery formulations of existing approved drugs, and which have established safety and tolerability profiles in their currently approved clinical indications. These product candidates are all in clinical development, including five Phase II trials.
AGI intends to complete its ongoing clinical trials and, dependent on the results of these trials, the Company will initiate late stage development of a lead product candidate and will also seek to enter into licensing and development agreements with pharmaceutical companies so as to enhance the global market reach for its products and achieve optimal revenue and value opportunities for the Company.
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.
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