“Thank you to the Alpha-1 patients that participated in this important clinical trial, InnovAATe. It is because of the dedication of patients and companies, like Kamada, that we learn more about Alpha-1 through trials and can get more answers. We are grateful for this investment in the Alpha-1 space and look forward to working with Kamada in the future, it is because of this commitment to the Alpha-1 community that research continues to move forward toward new therapies for patients worldwide,” said Scott Santarella, A1F President & CEO.
Important update on Kamada’s InnovAATe Phase 3 clinical trial of inhaled AAT for AATD:
Following a pre-specified interim futility analysis, the independent Data and Safety Monitoring Board (DSMB) has advised the company that the study is unlikely to demonstrate a statistically significant benefit in its primary endpoint (lung function measured by FEV1).
As a result, Kamada has decided to discontinue the study and is taking the appropriate steps to inform all participating clinical sites and other stakeholders of its decision. The study will be discontinued in an organized and efficient manner. The decision to discontinue the trial is solely related to the limited likelihood of a successful efficacy outcome should the trial continue to conclusion and is not reflective of any safety concerns related to the Inhaled AAT treatment. Kamada intends to collect the data, analyze it, and report it as appropriate.
We are grateful to the patients who participated in the trial, the AATD community, advocacy groups, physicians, clinical site teams, regulators, and all stakeholders who contributed to the trial. We remain committed to supporting the AATD community through the advancement and supply of our leading AAT-IV treatment, GLASSIA®, marketed internationally.
