DUBLIN, IRELAND--(Marketwire - January 20, 2009) -
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AGI Therapeutics
AGI completes patient enrolment in first RezularTM pivotal Phase III
study
- On target to report top-line results by end Q2 -
Dublin, Ireland, 20 January 2009 - AGI Therapeutics plc ("AGI" or
the"Company") (AIM, IEX: AGI), a speciality pharmaceutical development
company focused on gastrointestinal drug products, today announces the
completion of patient enrolment for ARDIS 1, the first pivotal Phase
III efficacy study of RezularTM. RezularTM is AGI's lead product for the
treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D), a
chronic, debilitating condition that affects millions of people.
A total of 711 patients have been randomised in 123 clinical centres in
the United States, Europe and South America for ARDIS 1. This study is
the first of two ongoing Phase III studies which will be included in a
future New Drug Application (NDA) submission to the Food and Drug
Administration (FDA) for approval of RezularTM in the U.S. Of the
total patients randomised, 63% are in the United States. The gender
breakdown of enrolled patients is 69% female and 31% male, which
closely reflects the gender ratio in the general IBS population.
Top-line results of this study are on track to be reported by the end
of the second quarter of 2009. The primary endpoint is patient global
relief of IBS symptoms, as agreed with the FDA.
Dr John Devane, CEO of AGI, commented:"The completion of enrolment in this
pivotal Phase III efficacy study
is a significant milestone for AGI. Recruitment for a further Phase III
study designed to assess extended safety of RezularTM in IBS-D patients
is also on track. The treatment of IBS-D is a major unmet medical need
with no significant safe and effective therapy generally available.
RezularTM is the most advanced programme in development for the
treatment of IBS-D, and is well positioned to become a significant new
therapy in the US market. 2009 promises to be a momentous year for our
company and we look forward to delivering on our objective of
progressing RezularTM to approval."
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 (AGI-003) is an orally administered multiple mechanism
intestinal regulator, a first-in-class mechanism for the treatment of
IBS-D. 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 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 RezularTM in IBS patients has already been
established in a Phase II trial, the preliminary results of which were
reported by the Company in 2006.
ARDIS is the Phase III programme agreed with FDA for RezularTM in the
treatment of IBS-D. 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 RezularTM) and patients will be treated for 12 weeks of
double-blind therapy. In July 2008, the Company announced that the US
FDA agreed the statistical approach to be used to analyse the ARDIS 1
study data, and also re-affirmed the previously agreed key parameters
of the RezularTM Phase III programme, and in particular the
acceptability of the current primary endpoint of patient-reported
global relief of IBS symptoms.
ARDIS 3 is an ongoing open-label safety study designed to capture 1
year extended safety in 100 IBS-D patients on continuous
RezularTM therapy
-- Ends --
Contact Information:
AGI Therapeutics plc. Tel: +353 1 449 3254
David Kelly, Chief Financial Officer
Financial Dynamics - UK Tel: +44 (0) 20 7269 7182
Jonathan Birt/John Dineen
Financial Dynamics - Ireland Tel: +353 1 663 3602
Niamh Lyons
Piper Jaffray Limited Tel: +44 (0) 20 3142 8700
Neil Mackison
Will Carnwath
Davy Tel: +353 1 614 8761
John Frain
For further information please see www.agitherapeutics.com.
Notes to Editors:
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 (KMETM) 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
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'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.
This information is provided by RNS
The company news service from the London Stock Exchange
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