Santersus is advancing NUC‑CAP, a multicentre, randomised pivotal study of NucleoCapture, its investigational extracorporeal blood‑purification technology, in critically ill patients with sepsis and respiratory failure.
The trial is expected to enrol up to 350 patients across clinical sites in the United States and Europe, with Axcellant appointed as global CRO to support international execution.
Participants will be randomized 1:1 to receive either standard of care alone or standard of care plus NucleoCapture. The study will assess device‑related safety and a primary effectiveness endpoint combining all‑cause mortality through day 28 with organ support‑free days through day 28, analysed using win‑ratio methodology.
The aim is to determine whether selectively removing circulating neutrophil extracellular traps can improve outcomes for patients requiring intensive care.
NucleoCapture is designed to remove NETs from the bloodstream through selective extracorporeal adsorption. NETs contribute to innate immune defence but have also been associated with inflammatory and thrombotic processes and organ injury when excessive or dysregulated.
The clinical significance of targeting NETs remains to be established. According to World Health Organization estimates for 2017, ~48.9 million people developed sepsis worldwide and 11 million deaths were associated with the condition.
The pivotal programme follows earlier development, including completion of a first‑in‑human exploratory study. In 2022, NucleoCapture received FDA Breakthrough Device Designation as an adjunctive treatment to antibiotics in sepsis.
James Ladtkow, Chief Executive Officer of Santersus, said: “The advancement of NUC-CAP into pivotal development is a significant milestone for Santersus because it moves NucleoCapture into a rigorous, multinational clinical program designed to evaluate endpoints that matter in the treatment of critically ill patients.”
He added: “Our objective is to build a robust body of clinical evidence around a differentiated therapeutic approach: directly removing circulating NETs that are associated with inflammatory, thrombotic and organ-damaging processes.”
Wojciech Kula, CEO of Axcellant, said: “We are pleased to support Santersus in the global execution of NUC-CAP.”
He continued: “The study represents an important clinical undertaking in a critically ill patient population, and our team will bring integrated clinical-development capabilities to support disciplined execution across participating regions.”
Santersus is targeting an interim analysis in Q4 2027, followed by potential CE certification and an EU launch in Q2 2028. PMA submission is planned for Q2 2029, with potential FDA approval and a US launch in Q4 2029.
