Dublin, Ireland, 15th May 2009
Announces top-line results of Phase III study of
Rezular™ in IBS-D
AGI Therapeutics plc ("AGI" or the "Company") (AIM, IEX: AGI), a speciality pharmaceutical development company focused on gastrointestinal drug products, today announces top-line results from it's Phase III clinical study, ARDIS 1, of Rezular™, in diarrhoea-predominant Irritable Bowel Syndrome (IBS-D).
•The study did not show statistically significant differences between
treatments in the primary endpoint of patient reported adequate relief
of IBS symptoms
•Statistically significant evidence favouring Rezular treatment was
achieved in a number of secondary endpoints, particularly those relating
to aspects of diarrhoea (e.g. stool form as assessed by the Bristol Stool
Scale), stool frequency and in the majority of sub-categories of quality-of-life
(IBS-QOL) scores and in the overall IBS-QOL score
•There were no statistically significant differences between treatments
in adequate relief of pain/discomfort or change in severity of pain
•Based on this preliminary data analysis, AGI does not believe that
Rezular will meet the regulatory requirements for an effective therapy
for the broad IBS-D population and plans to cease its development in this
indication.
ARDIS 1 was a randomised, double-blind, placebo-controlled, parallel group, Phase III study in IBS-D patients (both men and women). There were four treatment arms (placebo and three dose levels of Rezular™) and patients were treated for 12 weeks of double-blind therapy. A total of 711 patients were randomised in 123 clinical centres in the United States, Europe and South America. Of the total patients randomised, 63% were in the United States.
Dr John Devane, CEO of AGI, commented:
"A safe and effective therapy for patients with IBS-D remains elusive. We are very disappointed that this study did not achieve its primary clinical endpoint. While we saw evidence that Rezular™ has activity in many aspects of this multi-symptom disease, as in our earlier study, our experience in bringing products to market suggests to us that the pursuit of this product as a therapy for IBS-D would not be a prudent use of our resources. AGI has a promising portfolio of other products. Recently we announced positive proof-of-concept Phase II results for AGI004 in the treatment of chemotherapy-induced diarrhoea (CID) in cancer patients. We will now focus our efforts on prioritising our pipeline and plan how best to move these forward. We will keep our shareholders apprised of these plans."
Conference Call:
Please note that AGI will hold a conference call to discuss these results
today, beginning at 09:30 BST.
To participate, please call +353 1 486 0922 (Ireland) or +44 (0) 20 7806
1951 (UK) quoting the confirmation code 7142383. A slide presentation
accompanying this call will be available in the Investors/Publications
section of the AGI website 15 minutes before the call commences, or by
following this link: http://phx.corporate-ir.net/phoenix.zhtml?c=196905&p=irol-reports
Contact Information
AGI Therapeutics
David Kelly, Chief Financial Officer
Tel: +353 1 449 3254
Financial Dynamics - UK
Jonathan Birt/John Dineen
Tel: +44 (0) 20 7269 7182
Financial Dynamics - Ireland
Niamh Lyons
Tel: +353 1 663 3602
Piper Jaffray Limited
Neil Mackison
Will Carnwath
Tel: +44 (0) 20 3142 8700
Davy
John Frain
Tel: +353 (1) 614 8761
For further information please see www.agitherapeutics.com.
Notes to Editors:
About IBS-D and Rezular™
Irritable bowel syndrome 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 one of the most common diagnoses 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. IBS-D is estimated to occur in one-third of all IBS patients, and represents a significant unmet medical need, as there are currently few safe and effective therapeutic options available to these patients.
RezularTM 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), RezularTM has shown dominant activity in the gut without the traditional cardiovascular actions of the racemic drug. The efficacy and safety of RezularTM in IBS patients was established in a Phase II trial, the preliminary results of which were reported by the Company in 2006.
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
multiple mechanism 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, 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 novel 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.