Half of Patients Now Enrolled in SeaStar Medical’s NEUTRALIZE-AKI Trial

SeaStar Medical Holding Corporation has recruited more than half the patients for its NEUTRALIZE-AKI pivotal trial.

Fifty-one of 100 subjects have been enrolled to develop an interim analysis on the trial’s 90-day primary endpoint. The study is evaluating the safety and efficacy of SeaStar Medical’s proprietary therapeutic Selective Cytopheretic Device (SCD) in adults with acute kidney injury (AKI) in an intensive care unit (ICU) receiving continuous kidney replacement therapy (CKRT).

“The pace of enrollment in NEUTRALIZE-AKI has significantly accelerated, with recent momentum driving us past the halfway point toward the planned interim analysis,” said Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. “This current pace is encouraging as we work to activate additional clinical trial sites.”

SeaStar Medical’s SCD previously received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for adults with AKI, which is awarded to a therapy to treat a serious or life-threatening condition with preliminary clinical evidence indicating it may demonstrate substantial improvement over available therapies on clinically significant endpoints. In July 2024, the Centers for Medicare & Medicaid Services granted Category B coverage for certain expenses incurred by medical centers when treating Medicare or Medicaid patients enrolled in NEUTRALIZE-AKI.

In July 2024 SeaStar Medical began shipping the SCD Pediatric, brand named QUELIMMUNE, for pediatric patients with AKI and sepsis indications, having received Humanitarian Device Exemption (HDE) approval from the FDA earlier in the year.

The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) pivotal trial is expected to enroll up to 200 adults at up to 30 clinical sites. The trial’s primary endpoint is a composite of 90-day mortality or dialysis dependency of patients treated with SCD in addition to CKRT 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.

AKI is characterized by a sudden and temporary loss of kidney function and can be caused by various conditions such as COVID-19, sepsis, severe trauma, and surgery. AKI can cause hyperinflammation, which is the overproduction or overactivity of inflammatory effector cells and other molecules that can be toxic. Damage resulting from hyperinflammation in AKI can progress to other organs, such as the heart or liver, and potentially to multi-organ dysfunction or even failure that could result in worse outcomes, including death. Even after resolution, these patients may face chronic kidney disease or end-stage renal disease requiring dialysis, among other complications. Hyperinflammation may also contribute to added healthcare costs, such as prolonged ICU stays and increased reliance on dialysis and mechanical ventilation.

SeaStar Medical’s SCD is a patented cell-directed extracorporeal device that employs immunomodulating technology to selectively target proinflammatory neutrophils and monocytes during CKRT and reduces the hyperinflammatory milieu including the cytokine storm. Unlike pathogen removal and other blood-purification tools, the SCD is integrated with CKRT hemofiltration systems to selectively target and transition proinflammatory monocytes to a reparative state and promote activated neutrophils to be less inflammatory. This immunomodulation approach may promote long-term organ recovery and eliminate the need for future KRT, including dialysis.

The SCD-Pediatric device, brand named QUELIMMUNE, was approved in February under a Humanitarian Device Exemption (HDE) application.

SeaStar Medical is a commercial-stage medical technology company that is redefining how extracorporeal therapies may reduce the consequences of excessive inflammation on vital organs. Its technologies rely on science and innovation to provide life-saving solutions to critically ill patients. The company is developing and commercializing cell-directed extracorporeal therapies that target the effector cells that drive systemic inflammation, causing direct tissue damage and secreting a range of pro-inflammatory cytokines that initiate and propagate imbalanced immune responses.