A total of 711 patients have been randomized in 123 clinical centers in the US, 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 submission to the FDA for approval of Rezular in the US.
Of the total patients randomized, 63% are in the US. The gender breakdown of enrolled patients is 69% female and 31% male, which closely reflects the gender ratio in the general irritable bowel syndrome (IBS) population, the company said.
Top-line results of this study are on track to be reported by the end of the second quarter of 2009, the company added. The primary endpoint is patient global relief of IBS symptoms, as agreed with the FDA.
Rezular is AGI’s lead product for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), a chronic, debilitating condition.
John Devane, CEO of AGI, said: The completion of enrollment 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 Rezular 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. Rezular is the most advanced program in development for the treatment of IBS-D, and is well positioned to become a significant new therapy in the US market.