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Kamada Announces Expansion of Pivotal Phase 3 Clinical Trial of Inhaled AAT to Additional Six Clinical Sites Across Europe; and Positive Recommendation by DSMB to Continue the Trial Without Modification
REHOVOT, Israel, May 17, 2022 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a vertically integrated global biopharmaceutical company, focused
About this update from Kamada Ltd.
[{"type":"text","content":"REHOVOT, Israel, May 17, 2022 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a vertically integrated global biopharmaceutical company, focused on specialty plasma-derived therapeutics, today provided an update on recent progress achieved in its ongoing pivotal Phase 3 InnovAATe clinical trial evaluating the safety and efficacy of the Company’s proprietary inhaled Alpha-1 Antitrypsin (AAT) therapy for the treatment of Alpha-1 Antitrypsin Deficiency (AATD). Following the recent moderation of the global COVID-19 pandemic, the Company is expanding the study to new European sites. Clinical sites were recently opened in Belgium, Finland and Sweden, and patient enrollment has started. In the coming weeks, three additional sites in the UK, Ireland and the Netherlands are expected to open for patients’ enrollment. These six sites are in addition to the existing site in Leiden, the Netherlands, which has been active and recruited patients since study initiation in November 2019. Moreover, as part of routine and planned monitoring processes, the Independent Data Safety Monitoring Board (DSMB) recently recommended that the trial continue without modification. To date, no patients have discontinued treatment prematurely and no drug-related serious adverse events have been reported. Additionally, nine patients, treated at the Leiden site, have already completed the full two-year treatment period and are now under follow up. “With the global COVID-19 pandemic now moderating, we are excited to be in a position to expand this promising pivotal study, open new sites and expedite enrollment,” said Amir London, Kamada’s Chief Executive Officer. “Importantly, this is a unified trial, as the study’s data are expected to qualify for regulatory submissions with both the FDA and the EMA. A substantial opportunity exists for inhaled AAT to be a transformational next-generation augmentation therapy with the potential to improve patients’ convenience and quality of life compared to existing available IV treatments. The AAT market is already over $1 billion in annual sales in the U.S. and EU and growing steadily. We look forward to further expanding this trial, which is the most advanced investigational product for AAT deficiency.\" InnovAATe is a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial designed to assess the effi...