Dr. Kevin Chung, Chief Medical Officer at SeaStar Medical Holding Corporation ICU and Dr. Stuart L. Goldstein, MD, from Cincinnati Children’s Hospital Medical Center, were recently guests on Benzinga’s All-Access.
The two were on hand to discuss QUELIMMUNE, SeaStar Medical’s humanitarian medical device that was granted U.S. FDA approval to treat pediatric patients with acute kidney injury (AKI) due to sepsis or a septic condition. Dr. Goldstein was the chief investigator for the two studies that led to the FDA approval.
Pediatric AKI is a sudden episode of kidney failure that happens within a few hours or days. It can be brought on by several conditions including 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 lead to multi-organ dysfunction or even failure that could result in worse outcomes, including increased risk of death. Even after resolution, patients may face complications including chronic kidney disease or end-stage renal disease requiring dialysis.
Treating The Untreatable
There are about 4,000 cases of pediatric AKI each year in the U.S., Dr. Chung shared, and the mortality rate among those patients is high at 50%. QUELIMMUNE, which was granted approval under a Humanitarian Device Exemption (HDE) by the FDA in February 2024, was developed to treat AKI among children.
“QUELIMMUNE is designed to target the innate immune response. When patients get very sick, it becomes very dysregulated and cells go haywire and trigger something called the cytokine storm,” said Dr. Chung in the interview. “The QUELIMMUNE device is designed specifically to target the cytokine storm at the source of the storm, and it is associated with really good outcomes, especially in the pediatric population where mortality was cut in half from 50% to 25%.”
That reduction in mortality is quite promising given that while there have been medical advances in treating AKI over the years, including targeted medications, nothing has been able to help patients with AKI so severe that it requires dialysis or inflammation so bad that it has increased the chance of death, Dr. Goldstein noted. But QUELIMMUNE proved very effective in trials, surprising even Dr. Goldstein, and that is why it received FDA approval and is being used in hospitals around the country.
“What we saw as we started the initial trial is kids that had a 50% chance of mortality, not only did that go in half, but we saw a dramatic improvement almost in 24 to 48 hours, which was quite shocking to us frankly,” said Dr. Goldstein. What’s more, of the patients who survived, they were off dialysis sixty to ninety days later, something unheard of. Typically, 10-30% of pediatric patients who survive an AKI episode require chronic dialysis, Dr. Goldstein shared. “It’s a dramatic improvement that you see almost within the first one to two days. It is nothing I’ve seen before in clinical medicine in the last quarter century,” he stated further.
Looking Beyond Pediatric AKI
In addition to treating pediatric AKI, SeaStar is currently engaged in a trial evaluating the safety and efficacy of QUELIMMUNE for treating adult AKI. The study has over 100 patients enrolled, and the company is shooting for a total of 200. Beyond that, Dr. Chung said the idea is to use QUELIMMUNE for any condition in which the innate immune system is disturbed.
“The therapy itself is organ- and disease-agnostic,” said Dr. Chung, noting the company has six Breakthrough Device Designations from the FDA. BDD is designed to encourage speedier development of certain medical devices when there is a reasonable chance of providing a better treatment or diagnosis than the current standard of care. The BDD status is reserved for those diseases that are life-threatening or can cause irreversibly debilitating effects on patients.
“Other disease states are definitely going to be next,” Dr. Chung told Benzinga.
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