AGI-004 is in Phase II development for the treatment of diarrhoea-predominant irritable bowel syndrome (d-IBS)
AGI-004 is a controlled release transdermal patch
containing mecamylamine 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-004 is a controlled release form of mecamylamine
with a lower peak-to-trough drug exposure profile
which, coupled with a reduction in daily dosage,
has demonstrated marked GI effects and a reduction
of the traditional non-GI ganglion blocking effects. A
Phase II clinical trial evaluating the efficacy
of AGI-004 in the treatment of functional diarrhoea
is currently ongoing. In the event that AGI-004
is successful in the current clinical trial, AGI
expects that this product candidate will thereafter
be developed for the treatment of d-IBS.
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