SeaStar Medical announced details of its pivotal NEUTRALIZE-AKI study evaluating the safety and efficacy of its Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) requiring continuous kidney replacement therapy (CKRT). The recently approved study will be initiated in March and is expected to enroll up to 200 patients at up to 30 U.S. clinical trial sites. This randomized, controlled study, called NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via seLective cytopheretIc device - a randomiZEd clinical trial in Acute Kidney Injury), will evaluate the safety and efficacy of the SCD to quell the hyperinflammatory process and cytokine storm by targeting and neutralizing activated effector cells in critically ill adults with AKI requiring CKRT, a condition with a high mortality rate.

The study's primary endpoint is a composite of 90-day mortality or dialysis dependency among patients treated with SCD in addition to CKRT standard of care, compared with the control group receiving CKRT standard of care alone. Secondary endpoints include mortality at Day 28, ICU-free days in the first 28 days, major adverse kidney events at Day 90 and dialysis dependency at one year. The study will also include subgroups to explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome (ARDS).

The SCD is a patented, cell-directed extracorporeal therapy that selectively targets the most highly activated proinflammatory neutrophils and monocytes to stop the cytokine storm that can cause organ failure and death. SCD therapy is currently delivered through continuous CKRT to target and neutralize proinflammatory neutrophils and monocytes, allowing the body to return to homeostasis. The SCD received FDA Breakthrough Device Designation in 2022.

The SCD has demonstrated success in critically ill patients with AKI requiring CKRT in previous clinical studies. In the Company's SCD 005 pilot study evaluating the safety and feasibility of the SCD in COVID-19 patients with AKI and/or ARDS, patients experienced reductions in activated neutrophils and monocytes, which led to a reduction in proinflammatory cytokines and improved clinical outcomes. Based on the per-protocol minimum of 96 hours of SCD treatment, Day 60 mortality of treated patients was significantly lower at 31% compared with the control population treated under standard of care at 81%.

All patients in the study were treated in the ICU and received CKRT as the SCD delivery vehicle. In four additional non-COVID AKI studies in adults and children, patients treated with the SCD showed Day 60 reductions in mortality of up to 50% and no dialysis dependency, compared with 15% to 25% dialysis dependency in historical controls.