ARTICLE | Clinical News

Aerosolized Alpha-1 antitrypsin: Phase II started

March 31, 2014 7:00 AM UTC

Kamada began a double-blind, placebo-controlled, U.S. Phase II trial to evaluate 80 or 160 mg inhaled AAT twice daily for 12 weeks in 36 patients. Patients will be eligible to enroll in a 12-week, open-label extension study. The product, which uses the eFlow Nebulizer System from Pari, completed a European and Canadian Phase II/III trial to treat AAT deficiency, with top-line data expected by the end of April or the start of May and an MAA submission to EMA expected next half. ...