Kamada Completes Pivotal Phase II/III Trial In Europe & Canada Of Inhaled AAT

(RTTNews) - Kamada Ltd. (KMDA), a plasma-derived protein therapeutics company focused on orphan indications, has completed the pivotal Phase II/III study in Europe and Canada of its proprietary inhaled Alpha-1 Antitrypsin or AAT therapy for the treatment of Alpha-1 Antitrypsin Deficiency or AATD. The top-line results of this study are expected to be reported in the first quarter of 2014.

The multicenter randomized, double-blind, placebo-controlled study is assessing the safety and efficacy of Kamada's inhaled formulation of human AAT to treat AATD in >160 patients. The trial involved the inhalation of 160 mg of human AAT or placebo twice daily through the eFlow device for 50 weeks, and eligible patients were given the choice of participating in a 50-week open-label extension study. The primary endpoint is the difference in exacerbation events between the two groups at one year and is 80% powered to show a 20% difference. Secondary endpoints include additional parameters of exacerbation events, pulmonary function tests and safety.

Kamada received approval of its Investigational New Drug application from the U.S. Food and Drug Administration or FDA for a Phase II trial with inhaled AAT for AATD, and expects to begin that study in the coming months. The company's flagship product is Glassia, the first and only liquid, ready-to-use, intravenous plasma-derived AAT product approved by the FDA. Glassia is marketed in the U.S. via. a strategic partnership with Baxter International.