Cerus Corporation announced positive topline results from its Phase 3 RedeS trial, demonstrating that red blood cells treated with its INTERCEPT Blood System achieved non-inferior efficacy compared to conventional red blood cells based on adjusted hemoglobin increments. The trial showed no statistically significant difference in treatment-related adverse events (3.4% vs 2.5%). While 2.2% of INTERCEPT patients developed transient antibodies, no hemolysis or clinical impact was observed. The system remains investigational as the FDA has not yet reviewed the study.
Phase 3 RedeS primary efficacy results
- ▪In Cerus Corporation's Phase 3 RedeS trial of INTERCEPT-treated red blood cells, adjusted hemoglobin increment was 1.996 g/dL (INTERCEPT arm) vs 2.050 g/dL (control arm), meeting the non-inferiority margin (estimated -0.054 g/dL difference)
- ▪Cerus Corporation's Phase 3 RedeS trial evaluated INTERCEPT-treated red blood cells compared to conventional red blood cells in transfusion recipients
- ▪Cerus Corporation announced on November 2, 2026, that its Phase 3 RedeS trial evaluating the INTERCEPT Blood System for Red Blood Cells met its primary efficacy endpoint
Phase 3 RedeS trial safety findings
- ▪Cerus Corporation's Phase 3 RedeS trial showed no statistically significant difference in treatment-emergent adverse events between the INTERCEPT arm and the control arm (p=0.634)
- ▪In Cerus Corporation's Phase 3 RedeS trial, 2.2% of subjects in the INTERCEPT arm developed treatment-emergent, low-titer, transient INTERCEPT-specific antibodies compared to zero in the control arm
- ▪In Cerus Corporation's Phase 3 RedeS trial, 3.4% of subjects in the INTERCEPT arm experienced treatment-related adverse events compared to 2.5% in the control arm
- ▪The INTERCEPT-specific antibodies observed in the Phase 3 RedeS trial showed no evidence of hemolysis or clinical impact, consistent with findings from Cerus Corporation's prior ReCePI study
Regulatory status of INTERCEPT for Red blood cells
- ▪The INTERCEPT Blood System for Red Blood Cells remains investigational in the United States and has not been approved by the FDA
- ▪The INTERCEPT Blood System for Red Blood Cells is under regulatory review in Europe
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