Kamada completes final analysis of Phase III AAT deficiency trial

The trial, conducted in accordance with FDA requirements, was a controlled, randomized, double-blind, partial cross-over study that compared Kamada’s intravenous alpha-1 antitrypsin (AAT) with a comparator product.

Approximately 48 AAT-deficient patients were randomized 2:1 for the first 12-weeks to weekly infusion of Kamada’s AAT or weekly infusion of comparator drug; all patients then received Kamada’s AAT for a further 12 weeks. The efficacy endpoints of the study were determined by serum concentration of AAT and levels of AAT and other biomarkers in epithelial lung fluid. Safety parameters were explored and determined.

The results indicate the high quality of the Kamada product and its ability to reach the required trough levels in AAT patients, said Kamada. With regards to safety, no safety concerns were demonstrated. The safety profile was comparable to that of the comparator product, the company added.

David Tsur, CEO of Kamada, said: “This is a major achievement for Kamada and it marks another significant step in our strategy to enter the US market with this product. Our intravenous AAT is the only ready-to-use AAT product that does not require reconstitution before use, offering patients and care-givers a much more convenient treatment option.

“Additionally, the high purity of the product and the fact that it does not consist of any added substances increases its future acceptance in the medical community.”