Dublin, Ireland, 3rd October 2007
AGI announces first patient dosed in Phase III
trial of AGI-003, branded as Rezular™, in IBS-D
AGI Therapeutics plc ("AGI" or the "Company") (AIM,
IEX: AGI), a speciality pharmaceutical company focused on gastrointestinal
drug products, today announces that the first patient in its pivotal Phase
III study of AGI-003 (ARDIS) has been dosed. In conjunction with this
important milestone, AGI has branded AGI-003 as 'Rezular™' as it
continues to advance this product into the next phase of its development.
As reported previously, ARDIS-1 is a Phase III trial in 1,200 patients (men and women) which is being conducted under an IND with the FDA. The study design has been agreed with the FDA and if successful will be the first of 2 pivotal efficacy trials required for approval. ARDIS-1 is being conducted in over 130 sites, with a majority of these in the USA.
Patient enrolment is expected to continue into Q1 2008 and preliminary indications of efficacy are expected in the second half of 2008.
Patients who complete the 12 weeks of double blind treatment in ARDIS-1 are eligible to enrol into ARDIS-3, an open label safety study designed to provide one year safety data on up to 100 patients.
Commenting, Dr. John Devane, CEO, said
"Today's announcement of dosing the first patient in our pivotal
Phase III trial is another major milestone for AGI. We believe ARDIS will
confirm the therapeutic benefit of Rezular in IBS-D, a major unmet medical
need. We look forward to keeping both our shareholders and the medical
community informed on the continuing success of this important product
as it progresses towards regulatory approval.
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
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.