Dublin, Ireland, 8th October 2007
AGI's Rezular™ Phase II clinical data to be presented
at American College of Gastroenterology Scientific Meeting
-- 8.30a.m., Wednesday October 17, 2007 --
AGI Therapeutics plc ("AGI" or the "Company") (AIM, IEX: AGI), a speciality pharmaceutical company focused on gastrointestinal drug products, today announces the presentation of Phase II clinical results of Rezular, AGI's arverapamil (AGI-003) product, at the American College of Gastroenterology Scientific Meeting being held in Philadelphia.
Professor Eamonn Quigley, the principal investigator for the study will present the data as an oral presentation at 8.30a.m. on Wednesday Oct 17, 2007. Rezular is currently in Phase III clinical development for IBS-D and its first efficacy/safety study (ARDIS-1), which plans to treat 1200 patients, has begun to randomise and dose patients.
Rezular (AGI's arverapamil (AGI-003) product) is a single enantiomer of racemic verapamil, a drug that has been administered to patients for 35 years. Rezular represents a new first-in-class compound for IBS-D. It has a unique triple mechanism of action combining affinity at L-type calcium channels with 5-HT2b and melatonin (MT1) receptor binding.
In the Phase II study Rezular provided a significant therapeutic benefit over placebo in terms of patient global impression of IBS symptoms (19.4%) and relief of pain/discomfort (13.1%). In addition, patients on Rezular had significant improvement and obvious dose-response in various secondary end-points including the Bristol stool scale and an IBS-specific quality of life survey. Patients treated with Rezular tolerated all doses of the compound well with side effects typical of racemic verapamil and no serious adverse effects occurring.
Commenting, Dr. John Devane, CEO of AGI, said
"The presentation of our Phase II data to the wider gastroenterology community is timely given that patient randomisation in ARDIS-1 commenced on October 2nd. It is important that the gastroenterology community has the opportunity to not only see the robust therapeutic profile of Rezular but also to understand the unique mechanism of action that this compound offers. IBS is a complex condition and by harnessing a number of complementary activities into a single agent AGI's compound has significant therapeutic benefit and minimises the potential safety risks from the more traditional highly potent single mechanism drugs."
Contact Information
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
Piper Jaffray Limited
Neil Mackison
Will Carnwath
Tel: +44 (0) 20 3142 8700
Davy
John Frain
Tel: +353 (1) 614 8761
Notes to Editors:
About Rezular™ (AGI-003)
Rezular (AGI-003) is an orally administered triple-action intestinal regulator, a first-in-class mechanism for the treatment of IBS-D. Rezular 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), Rezular 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 Rezular in IBS patients has already been established in a Phase II trial, the preliminary results of which were reported by the Company in 2006.
About ARDIS
ARDIS represents AGI's Phase III programme for Rezular (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 Rezular) 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 Rezular 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 safe and effective therapeutic options available to these patients.
About AGI
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 that 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.