AGI Therapeutics plc, a speciality pharmaceutical company focused on gastrointestinal drug products, today announces the key pharmacology and clinical findings related to Rezular (arverapamil, AGI-003), which is being developed by the Company as a gastrointestinal-selective agent for the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D), recently presented at Digestive Disease Week (DDW) on Tuesday 20 May, 2008.
The key findings were:
(1) Rezular has a unique profile of receptor binding indicating a first-in-class mechanism involving melatonin and serotonin (5-HT2b), with a lesser contribution from L-type calcium channel blockade. This unique profile of receptor interaction may explain the breath of the efficacy profile of Rezular on the full range of IBS-D symptoms and its excellent safety profile seen to date.
(2) The post-hoc analysis of the Phase II clinical trial data for Rezular points to a higher response rate in mild to moderately severe (as measured by baseline pain) IBS patients than the already impressive response rates reported for all IBS patients reported previously. As most IBS patients are diagnosed as mild to moderately severe, the data suggests the potential for even greater efficacy of Rezular in these patients.
(3) The further post-hoc analysis indicated a poor level of correlation of different baseline symptom scores to a severity of illness score which further emphasizes the value of the traditional global response as a key measure of efficacy. This measure of global response was used as a primary endpoint in AGI's completed Phase II study and is also the primary endpoint in AGI's ongoing ARDIS 1 study.
For further information please see
www.agitherapeutics.com
Subscribe via RSS
