AGI-004

AGI-004 is a controlled release transdermal patch for the treatment of non-functional diarrhoea conditions, including chemotherapy-induced diarrhoea (CID). AGI-004 contains mecamylamine formulated for once-daily administration. The product provides a new anti-diarrhoeal mechanism via selective blockade of enteric nicotinic acetylcholine receptors (nAChR) and offers a significant advantage to current anti-diarrhoeal therapy via its convenient, once-daily transdermal form.

CID is a prevalent and severe toxicity associated with cancer chemotherapy treatment and can negatively impact a patient's health to the point that they are unable to tolerate their prescribed chemotherapy, commonly leading to delay or reduction in treatment which may diminish the therapeutic effect and overall outcome of treatment. Loperamide is at present the drug of choice for the management of mild to moderate CID, but is limited in terms of its effectiveness, tolerability and dosing flexibility, and there are currently few effective alternative therapies available.

AGI has reported the results of a Phase II clinical study of AGI-004 in the control of CID in cancer patients receiving chemotherapy, the results of which demonstrated a statistically significant benefit for AGI-004 in key measures of the incidence and severity of diarrhoea in these patients. AGI believes that AGI-004 may be a very beneficial and valuable therapy for cancer patients suffering from CID. AGI is seeking to partner AGI-004 for further development and commercial isation.