Kamada Phase II/III for Inhaled AAT

Kamada has obtained FDA approval for a Phase II/III clinical trial of AAT-IH, the inhalable version of its AAT drug for treatment of Alpha-1 antitrypsin deficiency for the treatment of congenital emphysema. The company believes that if its Phase II/III clinical trial currently underway in Europe is successful, the FDA may recognize the data, due in late 2013, for the purpose of the FDA study, together with the data due from the Phase II study.

Recognition of these data should shorten the obtaining of marketing approval of AAT-IH from the FDA. If approved, the drug will be the first inhalable treatment for congenital emphysema, caused by deficiency of the Alpha-1 antitrypsin protein.

AAT-IH offers topical delivery to the affected lung tissue, is non invasive, and has lower dose requirement potential to treat 3-4 times the number of patients, compared to AAT IV.