Kamada Ltd. provided an update on its pivotal Phase III InnovAATe clinical trial for inhaled Alpha-1 Antitrypsin therapy, announcing a revised enrollment goal of approximately 180 subjects. This revision follows an agreement with the U.S. FDA on a modified p-value of 0.1 for the study's statistical plan, which may allow for the acceleration of the program.
An interim futility analysis for the InnovAATe trial remains on track to be conducted by the end of 2025. This program is considered the most advanced efficacy study in a pivotal stage for inhaled AAT, positioning Kamada as a potential leader in the AATD market.
In parallel, Kamada is expanding its plasma collection operations with the planned opening of its third center in San Antonio, Texas, by the end of March 2025. This expansion supports the company's strategy to enhance its supply chain and generate additional revenue through the sale of normal source plasma.
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