Israel-based Kamada Ltd. (KMDA) reports preliminary top-line results from its 168-patient Phase 2/3 clinical trial for inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD).
The study failed to achieve its primary endpoint of time to the first moderate or severe exacerbation event at one year. There was no difference between the control and placebo groups.
A secondary endpoint, frequency of severe exacerbation, was 50% lower in the AAT group versus placebo.
Another secondary endpoint, Forced Expiration Volume in one second (FEV1), showed positive trends.
The data showed efficacy in certain subsets of patient populations.
The company expects to release a more extensive analysis of the results in Q3.