CalciMedica, Inc., a leading biopharmaceutical company currently in its clinical phase, announced on Monday the approval of their Investigational New Drug (IND) application by the United States Food and Drug Administration. The application was for their primary product candidate, Auxora.
Auxora is a powerful, selective inhibitor of Orai1-containing CRAC channels and is set to be examined in a Phase 2 trial for acute kidney injury (AKI) that is associated with acute hypoxemic respiratory failure (AHRF).
CalciMedica anticipates initiating the appropriately named KOURAGE trial in the first half of 2024 and expects to yield results by 2025.
Rachel Leheny, Ph.D., and CEO of CalciMedica, marked the IND clearance for the Phase 2 trial as a significant advancement for the company in their mission to address the urgent medical needs of patients suffering from severe AKI. With the KOURAGE trial, the company hopes to ascertain the potential benefits of Auxora for patients affected by severe AKI, and aims to decrease the high mortality rate associated with this severe condition.
