Kamada: Inhaled Alpha-1 Antitrypsin Phase 2/3 Trial Fails To Meet Endpoints

(RTTNews) - Kamada Ltd. (KMDA) announced the results from the complete analysis of the European Phase 2/3 clinical study of its inhaled Alpha-1 antitrypsin, or AAT, therapy for the treatment of Alpha-1 antitrypsin deficiency. The company confirmed that the study's primary endpoint of "Time to the first moderate or severe exacerbation event" did not show a statistically significant difference between inhaled AAT and placebo in the Intent-to-Treat population, as reported in May 2014. The study did not show statistically significant differences between inhaled AAT and placebo in the secondary exacerbation endpoints measured in the Intent-to-Treat population.

The company said its inhaled AAT therapy showed clinically relevant changes in various lung function measurements for the entire Intent-to-Treat population, as well as for the Most Frequent Exacerbators population, a few of which were statistically significant. The company noted that this suggests evidence of therapeutic activity resulting in a clinically relevant and meaningful effect for the first time in studies of any AAT treatment.

Kamada said it remains steadfast in conducting continued clinical work in support of inhaled AAT, including ongoing open-label extension study in Europe and Phase 2 U.S. study, as well as other future studies.