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Kamada Provides Update on Recent Progress Achieved in Ongoing Pivotal Phase 3 Clinical Trial of Inhaled AAT
Trial Recruitment Beginning to Accelerate; 30 Patients Enrolled and Treated to DateIndependent Data Safety Monitoring Board (DSMB) Recommends Study
About this update from Kamada Ltd.
[{"type":"text","content":"Trial Recruitment Beginning to Accelerate; 30 Patients Enrolled and Treated to DateIndependent Data Safety Monitoring Board (DSMB) Recommends Study Continuation Without Modification for Fourth Time Since Study InitiationBased on Encouraging Safety Observed to Date, Trial Inclusion Criteria Revised to Also Include Patients with Severe Airflow Limitation, Thereby Expanding Potential Patient Treatment PopulationCompany Intends to Meet with U.S. Food and Drug Administration and European Medicines Agency During First Half of 2023 to Discuss Study Progress and Potential Opportunities to Shorten the Regulatory Pathway REHOVOT, Israel and HOBOKEN, N.J., Nov. 07, 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). Earlier this year, following the moderation of the COVID-19 pandemic, the study was expanded to additional sites across Europe and enrollment has recently begun to accelerate. To date, 30 patients have been enrolled for treatment, including 14 patients who have already completed the two-year study treatment period at the initial trial site in Leiden, the Netherlands. Importantly, none of these patients discontinued treatment prematurely and no drug-related serious adverse events were reported. Additionally, as part of routine and planned monitoring processes, and for the fourth time since study initiation, the independent Data Safety Monitoring Board (DSMB) recently recommended that the trial continue without modification. Moreover, based on the encouraging safety observed to date, the DSMB supported an expansion to the inclusion criteria to also include subjects with severe airflow limitation (40%","length":2970,"tagName":"div"}]