FDA accepts IND filing for AGI's arverapamil

Dublin, Ireland-based AGI Therapeutics, a specialist developer of pharmaceutical products for gastrointestinal disorders, says that the US Food and Drug Administration has accepted its Investigational New Drug filing for arverapamil (AGI-003), AGI's treatment for diarrhea-predominant irritable bowel syndrome. Based on the FDA's review and comments on the IND, no significant changes are required to the pivotal Phase III study designs and AGI remains on track to initiate two of these studies this year.

In April, the company reported on its pre-IND meeting with FDA. Subsequently, AGI prepared and filed the IND in June which contained details of the planned Phase III program design, encompassing three pivotal Phase III studies in total. The IND also included the full protocols for two of these studies; ARDIS-1, a pivotal Phase III efficacy/safety trial, and ARDIS-3, an open-label safety study, to evaluate arverapamil in IBS-D, both of which will now begin. The agent is a single enantiomer moiety of the racemic drug verapamil. Unlike the currently-available commercial forms of the drug, which contain both enantiomers, arverapamil shows a dominant activity in treating the symptoms of IBS-D without the traditional cardiovascular actions of the racemic drug.