Cerus reported that additional options totaling $46.6M have been exercised under its contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.
“The allocation of additional options, coupled with recent FDA feedback on the dossier of clinical data required for a possible future red cell PMA submission, confirm our next steps forward for INTERCEPT red blood cells (RBCs) in the U.S.,” said Richard Benjamin, M.D., Ph.D., Cerus’ CMO. “Importantly, funds have now been allocated to support our planned Phase III ReCePI study, which is designed to evaluate the efficacy and safety of INTERCEPT RBCs to treat acute anemia in cardiovascular surgery patients.”
In addition to funding the proposed Phase III ReCePI study, the newly exercised options include support for a clinical study in the U.K. to evaluate the efficacy and safety of INTERCEPT RBCs in patients undergoing exchange transfusion for sickle cell disease. This tranche of funding also allocates funds toward the development of the INTERCEPT RBC System design to enable expanded use and manufacturing scaleup of key components.
The total value of the full 5-year contract is up to $186 million, subject to funding of additional contract options, and provides nondilutive funding to support a comprehensive development program for the pathogen reduction of RBC components in the U.S. Funding allocated to date, including the latest tranche, totals $88.4 million. Previously allocated funds are already supporting the Phase III RedeS trial to assess the safety and efficacy of INTERCEPT RBCs compared to conventional RBCs in regions at risk for the Zika virus.