Positive Phase 3 Trial Results for INTERCEPT Red Blood Cells in Cardiac Surgery

Cerus Corporation has reported successful findings from the ReCePI Phase 3 clinical trial, which evaluated the efficacy and safety of its INTERCEPT Red Blood Cells (RBCs) in patients undergoing complex cardiac surgery. The study showed that INTERCEPT RBCs were non-inferior to standard RBCs in terms of acute kidney injury (AKI) incidence, an important marker for assessing the effectiveness of RBC transfusion.

In the trial, AKI occurred in 29.3% of patients who received INTERCEPT RBCs and 28.0% of those who received conventional RBCs, indicating the non-inferiority of the treated cells with a 95% confidence interval upper limit of 10.4%, which is below the non-inferiority threshold of 14.0%. The safety of INTERCEPT RBCs was also comparable to conventional RBCs, with a slight difference in treatment-emergent adverse events within 28 days of the last transfusion, which was not statistically significant.

Cerus' INTERCEPT Blood System is designed to inactivate pathogens and donor leukocytes in RBCs, using a small molecule compound that forms bonds within nucleic acids to prevent pathogen replication. The system aims to preserve the therapeutic qualities of RBCs without requiring nucleic acid replication for efficacy.

The company plans to submit a modular premarket approval application to the U.S. Food and Drug Administration in 2025, with the final submission expected in 2026, following the completion of the RedeS Phase 3 clinical trial. The ReCePI trial's data will be presented at medical conferences and submitted for peer-reviewed publication.

Cerus is focused on safeguarding the global blood supply and developing pathogen-protected blood components. Its INTERCEPT Blood System for platelets and plasma is already available globally and has received regulatory approval. The company is also developing the INTERCEPT system for RBCs, which is currently under regulatory review in Europe and in late-stage clinical development in the U.S.

The ReCePI trial was a multicenter, randomized, double-blinded study involving 581 patients at high risk of needing RBC transfusion during complex cardiovascular surgery. The primary endpoint was the proportion of patients with AKI, defined by increased serum creatinine levels within 48 hours post-surgery. Safety endpoints included treatment-emergent adverse events and the development of antibodies specific to INTERCEPT RBCs.

Cerus Corporation is headquartered in Concord, California, and is dedicated to becoming a leading global blood products company. It supplies technologies and blood components to blood centers, hospitals, and patients, ensuring the safety and efficacy of blood transfusions. The company's INTERCEPT Blood System for Cryoprecipitation is also approved in the U.S. for the production of a therapeutic product to treat and control bleeding associated with fibrinogen deficiency.