Dublin, Ireland, 18 July, 2008 - AGI Therapeutics plc ("AGI" or the "Company") (AIM, IEX: AGI), a speciality pharmaceutical company focused on gastrointestinal drug products, today reports on the outcome of a recent meeting with the US Food and Drug Administration (FDA) in relation to its ARDIS Phase III programme for Rezular™ in diarrhoea-predominant irritable bowel syndrome (IBS-D) and provides an update on the overall progress of the ARDIS program.
AGI met the FDA’s Division of Gastroenterology Products, at the Company’s request, to finalise a number of aspects of the Rezular development programme, including the specific statistical approach to the analysis of efficacy data for ARDIS 1, the ongoing Phase III efficacy study which began in late 2007. As a result of its discussions with the FDA, AGI now intends to enrol a total of 680 patients in this study. The last patient is expected to be enrolled in Q4 2008 or Q1 2009, with preliminary data anticipated in H1 2009.
The FDA and AGI agreed the statistical plan to be used to analyse the ARDIS 1 data, allowing AGI to revise the target enrolment in ARDIS 1 to 170 patients in each of the four study arms. The FDA also re-affirmed the previously agreed key parameters of the ARDIS programme, and in particular the acceptability of the current primary endpoint of patient global relief.
Dr. John Devane, CEO of AGI, commented:
“This was a positive meeting for AGI which confirms our strategy for the ARDIS Phase III clinical trial. The agreement on the statistical plan allows us to finalise the target enrolment for ARDIS 1 and ensure that the study has sufficient power to meet our goals. We believe that this development, along with other positive outcomes from the meeting, including the FDA’s confirmation of the design and primary endpoint of the ARDIS programme, underpins the promise and value of our lead product, Rezular.”
ARDIS 1 now has more than 100 sites enrolling patients in the US, Europe and South America. The majority of these sites are in the US. After a slower than expected pace of site initiation and enrolment, enrolment rates have steadily improved and more than 400 patients have been randomised to date. Based on current enrolment rates, AGI expects to complete enrolment in late 2008 or early 2009. Approximately 80% of ARDIS 1 patients are continuing to roll over into ARDIS 3, the one-year open-label safety extension study. This should enable AGI to meet the target for ARDIS 3 of 300 patients treated with Rezular for six months and 100 patients treated for one year, as agreed with the FDA. ARDIS 3 data is therefore expected to be available in the first half of 2010. ARDIS 2, the third and final Phase III study of the ARDIS programme, is expected to commence as soon as results of ARDIS 1 are available next year.
The ARDIS Phase III clinical programme, including the primary study endpoint, was originally agreed with the FDA under an Investigational New Drug (IND) application submitted in June 2007. The IND included the design of the ARDIS clinical programme, which incorporates three pivotal Phase III clinical studies, of which two studies, ARDIS 1, the first of two pivotal efficacy studies, and ARDIS 3, a safety study, are currently underway. A number of items, most notably the statistical approach to the analysis of efficacy data, were deferred at that time for future discussion and agreement.
AGI submitted a request in January 2008 for a Type C meeting with the FDA to obtain feedback and agreement on various aspects of the programme. A key goal was to agree the statistical plan, with resulting sample size parameters, for ARDIS 1 and to re-affirm the acceptability of the ARDIS development programme given recent initiatives on patient reported outcome endpoints.
Contact Information:
AGI Therapeutics plc. Tel: +353 1 449 3254
David Kelly, Chief Financial Officer
Financial Dynamics – UK Tel: +44 (0) 20 7269 7182
Deborah Scott/Jonathan Birt/Lara Mott
Financial Dynamics - Ireland Tel: +353 1 663 3607
Aisling Garvey
Piper Jaffray Limited Tel: +44 (0) 20 3142 8700
Neil Mackison
Will Carnwath
Davy Tel: +353 1 614 8761
John Frain
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.
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 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 (KME) approach to drug re-profiling and development. The Company’s lead product candidate, RezularTM, is an orally administered triple-action 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 (IBS), 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 new 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.
