Rezular™

Rezular (AGI-003) is an orally administered multiple-mechanism intestinal regulator, a first-in-class mechanism for the treatment of chronic diarrhoea symptoms, particularly those associated with altered gut motility. Rezular contains arverapamil, a single enantiomer moiety of the racemic drug verapamil. Unlike the currently available commercial forms of racemic verapamil (a mixture of two enantiomers), Rezular shows a dominant activity in treating intestinal symptoms without the traditional cardiovascular actions of the racemic drug.

The efficacy and safety of Rezular has been evaluated in Phase II and Phase III efficacy trials and in a long-term safety study in patients with diarrhoea-predominant irritable bowel syndrome (IBS-D). The results of these trials has confirmed that Rezular offers a potential treatment for chronic diarrhoea symptoms in a variety of conditions associated with altered gut motility, while the trials also confirmed the excellent safety profile of the drug.

AGI has identified a number of diarrhoea-associated indications for the further clinical development of Rezular which represent areas of unmet medical need. In addition, based on the unique pharmacology of Rezular, AGI has identified a new indication that is unrelated to the treatment of diarrhea symptoms and is not in the GI therapeutic area, but is an established Orphan indication where Rezular may have a valuable and unique benefit. AGI will pursue the further development of Rezular in these indications, either itself or in collaboration with partners. .