SeaStar Medical enrolls 21 subjects in NEUTRALIZE-AKI trial, launches Quelimmune

SeaStar Medical Holding provides updates on the acute kidney injury programs it is developing with its patented, first-to-market, cell-directed Selective Cytopheretic Device extracorporeal therapy in critically ill patients with AKI. “We now have 21 subjects enrolled across five clinical sites in our NEUTRALIZE-AKI pivotal clinical trial, which is intended to evaluate the safety and efficacy of our SCD in adult AKI patients. Additional sites are progressing through the site activation and contract completion process,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “We expect the pace of enrollment will accelerate as more medical centers come onboard. We anticipate conducting an interim analysis once we have reached our 90-day primary endpoint in 100 enrolled subjects, which we expect to reach in the second half of 2024.” The NEUTRALIZE-AKI pivotal trial is expected to enroll up to 200 adults. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD in addition to continuous kidney replacement therapy as the standard of care, compared with the control group receiving only CKRT standard of care. Secondary endpoints include mortality at 28 days, 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 subgroup analyses to explore the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome. More information on the trial is available here. In February 2024 the U.S. Food and Drug Administration granted a Humanitarian Device Exemption Approval Order to the Quelimmune pediatric device for use in children weighing 10 kilograms or more with AKI due to sepsis or a septic condition requiring kidney replacement therapy. SeaStar Medical estimates the eligible population for its Quelimmune pediatric device to be approximately 4,000 children annually with AKI. About 20% of the top 50 children’s hospitals already have direct experience with the SCD. Pediatric patients undergoing treatment with the SCD are expected to require, on average, seven SCD units, with the disposable device being changed once every 24 hours. With the Approval Order, SeaStar Medical can build Quelimmune Clinical Kits into inventory in parallel to the hospital approvals process.