AGI Announces top-line results of Phase III study of Rezular™ in IBS-D
Dublin, Ireland, 15 May 2009: 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™, 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™) 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™ 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."
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