AGI-003 is in
Phase II development for the treatment of diarrhoea-predominant
Irritable Bowel Syndrome (d-IBS)
AGI-003 is an oral dosage form of arverapamil (the
R-isomer of verapamil) which is being developed
by AGI for the treatment of diarrhoea-predominant
irritable bowel syndrome ("d-IBS") in
both men and women.
IBS is a functional disorder (i.e. an abnormality or disturbance of normal function
which cannot be directly attributed to anatomical or biochemical defects) that
comprises a cluster of gastrointestinal symptoms which are likely to be life
long and can include diarrhoea, constipation, abdominal pain and distension,
which vary in intensity. Altered intestinal motility is a major component of
IBS and patients are diagnosed and sub-typed according to their predominant symptom
of bowel disturbance as either "d-IBS", constipation-predominant ("c-IBS")
or mixed/alternating symptoms of diarrhoea and constipation ("m-IBS").
The prevalence of IBS has been estimated in US population-based studies at between
10 and 20 per cent and surveys conducted in Europe estimate a similar range of
IBS prevalence there. It is estimated that there is an approximate equal prevalence
of each of the d-IBS, c-IBS and m-IBS sub-types. IBS is reported to be about
twice as prevalent in women as in men. While an estimated 75 per cent or more
of current sufferers remain undiagnosed and untreated, IBS remains the most common
diagnosis made by gastroenterologists and leads to a substantial reduction in
quality of life, accompanied by considerable socio-economic and psychological
consequences.
AGI-003 is being targeted to compete in the diarrhoea-predominant segment of
the IBS market, which is estimated to account for approximately one third of
all IBS patients. The annual market for prescription therapeutic drug products
for IBS in the US was estimated at more than US$350 million in 2003 and is predicted
to grow rapidly to more than US$1 billion by 2010. These sales are currently
largely for products treating the c-IBS component, and whose use is currently
restricted to women only and we believe that there are significant market opportunities
for new d-IBS therapeutic drug products.
A solid oral dosage form of AGI-003 has been developed and a Phase II clinical
trial evaluating the efficacy of AGI-003 in the treatment of non-constipation
predominant irritable bowel syndrome is currently ongoing.
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