Dublin, Ireland, 21st May 2008
AGI Therapeutics reports key pharmacological and
clinical findings for Rezular™ presented at DDW in San Diego
The key findings were:
(1) Rezular has a unique profile of receptor binding indicating a first-in-class
mechanism involving melatonin and serotonin (5-HT2b), with a lesser contribution
from L-type calcium channel blockade. This unique profile of receptor
interaction may explain the breath of the efficacy profile of Rezular
on the full range of IBS-D symptoms and its excellent safety profile seen
to date.
(2) The post-hoc analysis of the Phase II clinical trial data for Rezular points to a higher response rate in mild to moderately severe (as measured by baseline pain) IBS patients than the already impressive response rates reported for all IBS patients reported previously. As most IBS patients are diagnosed as mild to moderately severe, the data suggests the potential for even greater efficacy of Rezular in these patients.
(3) The further post-hoc analysis indicated a poor level of correlation of different baseline symptom scores to a severity of illness score which further emphasizes the value of the traditional global response as a key measure of efficacy. This measure of global response was used as a primary endpoint in AGI's completed Phase II study and is also the primary endpoint in AGI's ongoing ARDIS 1 study.
Commenting on the results, Dr. John Devane, CEO of AGI, said:
"The results presented at DDW have significantly extended our understanding of the mechanisms by which Rezular acts in the intestine. The unique profile of receptor interaction in addition to the potential for greater efficacy of Rezular in mild to moderately severe IBS patients further supports our belief that Rezular offers important safety benefits in the treatment of gastrointestinal-related disorders.
Contact Information
AGI Therapeutics
David Kelly, Chief Financial Officer
Tel: +353 1 449 3254
Financial Dynamics - UK
Deborah Scott/Lara Mott
Tel: +44 (0) 20 7269 7182
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™
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 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 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.