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Clinical study supports the pharmacokinetic and safety profile of RezularTM

Dublin, Ireland, 21 February 2008 - AGI Therapeutics plc ("AGI" or the "Company") (AIM, IEX: AGI), a speciality pharmaceutical company focused on gastrointestinal drug products, today announces the key findings of a clinical study to assess the pharmacokinetic profile of RezularTM (AGI-003), which is in Phase III clinical trials for the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D).

The pharmacokinetic study was conducted in healthy human volunteers and compared the drug exposure profile (in terms of both peak plasma concentration, or "Cmax", and area under the plasma concentration curve, or "AUC") after administration of 80mg of Rezular, under fed and fasting conditions, to 160mg of a marketed form of racemic verapamil. Rezular contains arverapamil, the purified R-isomer form of verapamil, whereas racemic verapamil contains equal amounts of the R- and the S-isomer.

The key findings of the study were:

(1) There were no detectable levels of the S-isomer following Rezular administration under fasting conditions and thus no evidence of any inter-conversion of Rezular to the S-isomer in vivo. Administration of Rezular under fed conditions resulted in some increase in AUC of the R-isomer compared to fasting conditions, while the S-isomer was only detected in the plasma at trace levels matching the trace amounts known to be present in the purified form of Rezular. These data indicate that the gastrointestinally active R-isomer, arverapamil, contained in Rezular can be administered to humans without exposing them to clinically relevant levels of the S-isomer, the form of verapamil which is most potent on cardiac and vascular tissue; and

(2) Under both fed and fasting conditions, both the Cmax and AUC of the R-isomer after Rezular administration were less than those seen after administration of racemic verapamil. This indicates that patients taking clinically relevant doses of Rezular will be exposed to lower systemic levels of the R-isomer compared to currently approved forms of racemic verapamil, and further supports the NDA 505(b)2-based development approach agreed with the US Food and Drug Administration (FDA) for Rezular.

Commenting on the results, Dr John Devane, CEO of AGI, said:

"Verapamil has been on the market in the US for over 20 years, however the presence of the S-isomer does not allow the use of racemic verapamil to safely treat gastrointestinal conditions such as irritable bowel syndrome. We believe that Rezular has important safety benefits in the treatment of gastrointestinal-related disorders. The findings from this pharmacokinetic study further support the safety profile of Rezular and the development strategy being pursued by the Company."

Contact Information:

For further information please see www.agitherapeutics.com

Notes to Editors:

About the study

The pharmacokinetic study was a single-dose, open-label, randomized, three-way crossover study in 16 healthy subjects (8 males, 8 females). The treatments were RezularTM (80mg) administered under fasting and fed conditions and Calan® (160mg) administered under fasting conditions. Calan is an FDA-approved form of racemic verapamil which is used to treat cardiovascular disorders. Blood samples were taken periodically up to 48 hours after each administration. Plasma concentrations of the R- and S-isomers of verapamil were measured using a validated Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS) method. All treatments in the study were well tolerated.

About Rezular™

Rezular is an orally administered triple-action intestinal regulator, a first-in-class mechanism for the treatment of IBS-D. Rezular contains arverapamil, the pure R-isomer form of the racemic drug verapamil. Unlike the currently available commercial forms of verapamil (a racemic mixture of two isomers, R and S), Rezular shows a dominant activity in treating the symptoms of IBS-D without the traditional cardiovascular actions exerted by the S-isomer component 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 and presented at the 2007 Scientific Meeting of the American College of Gastroenterology. Rezular is currently in Phase III clinical trials (ARDIS) for the treatment of IBS-D.

About ARDIS

ARDIS represents AGI's Phase III programme for Rezular 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.

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