Cerus announces ReCePI trial met primary efficacy endpoint

Cerus announced topline results for ReCePI, a Phase 3 clinical trial of pathogen reduced INTERCEPT Red Blood Cells transfused to complex cardiac surgery patients. The trial met its primary efficacy endpoint, demonstrating non-inferiority for INTERCEPT RBCs compared to conventional RBCs as measured by the incidence of acute kidney injury, or AKI, following transfusion of study RBCs. AKI is a sensitive transfusion efficacy indicator of RBC tissue oxygen delivery. In transfused subjects, by modified intent to treat the incidence of AKI was 29.3% for INTERCEPT RBC recipients compared to 28% for conventional RBC recipients, demonstrating non-inferiority of INTERCEPT RBCs compared to conventional RBCs with an upper limit of the 95% confidence interval of 10.4% compared with a non-inferiority margin of 14%. The safety endpoint of the proportion of patients with any related treatment-emergent adverse events, or TEAEs, within 28 days of last transfusion was not significantly different for INTERCEPT RBCs compared to conventional RBCs. There was no clinical significance related to treatment-emergent RBC antibodies observed in five patients receiving INTERCEPT RBCs. The trial’s independent Data Safety and Monitoring Board, or DSMB, evaluated these patients and was supportive of continued transfusion, having found no adverse health effects from trial transfusions. This safety endpoint is also being explored in the Company’s ongoing RedeS Phase 3 clinical trial of INTERCEPT RBCs. Cerus plans to include data from both the ReCePI and RedeS clinical trials in an integrated safety analysis as part of its planned modular premarket approval, or PMA, submission. Cerus anticipates initiating a modular PMA application to the FDA in the second half of 2025, with the final PMA module submission planned for the second half of 2026, upon the anticipated completion of the RedeS clinical trial. Data from preclinical studies, manufacturing information, previously reported Phase 1 and Phase 2 clinical trials in the U.S., and the successfully completed Phase 3 clinical trials in the EU will be included in the modular PMA submission. Cerus expects the data from the ReCePI clinical trial to be presented at upcoming medical conferences as well as to be submitted for peer reviewed publication.