




Healthcare Industry News: Gastroparesis
News Release - May 15, 2009
AGI Therapeutics: Top-line results of Phase III study of Rezular
AGI Therapeutics Announces top-line results of Phase III study of Rezular(TM) in IBS-DDublin, Ireland, 15 May 2009 - (HSMN NewsFeed) - 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(TM), 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(TM))
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(TM) 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
For further information please see http://www.agitherapeutics.com.
Notes to Editors:
About IBS-D and Rezular(TM)
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.
Rezular(TM) 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(TM) has
shown dominant activity in the gut without the traditional
cardiovascular actions of the racemic drug. The efficacy and safety of
Rezular(TM) 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.
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 currently 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 http://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.
Source: AGI Therapeutics
Issuer of this News Release is solely responsible for its
content.
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