SeaStar Medical has successfully reached the halfway enrollment milestone in its NEUTRALIZE-AKI pivotal clinical trial, enabling a prespecified interim analysis by the trial's independent Data Safety Monitoring Review Board (DSMB). The company anticipates receiving the DSMB's findings in the third quarter of 2025.
The NEUTRALIZE-AKI trial is evaluating SeaStar Medical's Selective Cytopheretic Device (SCD) therapy as a treatment for adult patients with Acute Kidney Injury (AKI) requiring continuous renal replacement therapy (CRRT). With 100 patients now enrolled out of a planned 200, the trial has reached a critical juncture for assessing safety and efficacy parameters.
"We are very pleased to reach this important enrollment milestone in the NEUTRALIZE-AKI pivotal trial," stated Eric Schlorff, CEO of SeaStar Medical. "Kevin and his team have done an incredible job activating nationally recognized clinical trial sites, such as Cleveland Clinic, Mayo Clinic, and Stanford Medical Center. These and our other clinical sites are clearly aware of the high unmet need of these patients, and we are grateful for their active participation in the trial."
Trial Design and Endpoints
The NEUTRALIZE-AKI (NEUTRophil and monocyte deActivation via SeLective Cytopheretic Device – a randomIZEd clinical trial in Acute Kidney Injury) study is evaluating the SCD therapy in addition to standard CRRT compared to CRRT alone. The trial's primary endpoint is a composite of 90-day mortality or dialysis dependency.
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 exploring the effectiveness of SCD therapy in AKI patients with sepsis and acute respiratory distress syndrome.
The interim analysis will be blinded to all parties except the DSMB and is designed to evaluate the safety profile and powering assumptions for the trial. Based on the results, the DSMB may recommend proceeding with the trial as planned, adjusting the sample size, or in rare circumstances, stopping the trial for either efficacy or futility.
"Prior interventional studies of the SCD therapy demonstrated improved treatment outcomes in patients treated with SCD when compared to standard of care," stated Kevin Chung, MD, Chief Medical Officer of SeaStar Medical. "The NEUTRALIZE-AKI pivotal trial is rigorously powered to detect a true efficacy signal, and confirming safety remains a top priority. This interim analysis seeks to validate the therapy's safety profile and efficacy potential – critical factors in supporting a DSMB recommendation to proceed to full trial completion."
Understanding AKI and the SCD Therapy
Acute Kidney Injury is characterized by a sudden and temporary loss of kidney function and can be caused by various conditions including COVID-19, sepsis, severe trauma, and surgery. AKI can trigger hyperinflammation, which involves the overproduction or overactivity of inflammatory cells and molecules that can cause widespread damage.
The consequences of AKI-related hyperinflammation can be severe, potentially progressing to multi-organ dysfunction or failure, resulting in worse outcomes including increased risk of death. Even after resolution, patients may face chronic kidney disease or end-stage renal disease requiring long-term dialysis. Currently, over 200,000 adults in the U.S. are affected annually by this life-threatening condition with limited treatment options.
SeaStar Medical's SCD therapy is designed as a disease-modifying device that neutralizes over-active immune cells and stops the cytokine storm that causes destructive hyperinflammation. Unlike other blood-purification approaches, the SCD therapy integrates with existing CRRT systems to selectively target and transition proinflammatory monocytes to a reparative state while reducing neutrophil inflammation.
This immunomodulation approach aims to promote long-term organ recovery, potentially eliminating the need for future renal replacement therapy, including dialysis, and preventing loss of life.
Regulatory Pathway and Commercial Potential
The SCD therapy has been granted FDA Breakthrough Device Designation for its application in treating AKI. This designation is awarded to devices that provide more effective treatment for life-threatening conditions, represent breakthrough technology, address unmet medical needs, or offer significant advantages over existing alternatives.
The Breakthrough Device Designation provides SeaStar Medical with a potentially expedited pathway to regulatory approval and favorable reimbursement dynamics upon commercial launch. The company has already achieved FDA approval for QUELIMMUNE (SCD-PED), its pediatric version of the device for treating life-threatening AKI due to sepsis in critically ill pediatric patients.
If successful in the NEUTRALIZE-AKI trial, the SCD therapy could address a significant unmet need in adult AKI patients requiring CRRT, potentially reducing mortality, dialysis dependency, and healthcare costs associated with prolonged ICU stays and long-term complications.
The company expects the DSMB to report its findings from the interim analysis in Q3 2025, which will provide important insights into the therapy's safety profile and potential efficacy, guiding the remainder of the trial.
