CalciMedica (NASDAQ:CALC) has announced late-breaking positive data from its Phase 2b CARPO trial of Auxora in acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS). The results are to be presented at the 2024 American College of Gastroenterology (ACG) annual scientific meeting.
“CARPO has delivered results that mirror those from previous Phase 2 trials of Auxora in other acute critical diseases and represents a significant step forward for the development of CRAC channel inhibitors in these diseases,” said Sudarshan Hebbar, M.D., CMO of CalciMedica.
“The CARPO results highlight Auxora’s unique immunomodulatory action coupled with direct organ tissue protection, most importantly in the lung, and provide an optimistic readthrough to the acute kidney injury, or AKI, setting, where respiratory failure is also a significant cause of mortality. With these data, we are even more encouraged about KOURAGE, our Phase 2 trial in AKI patients with respiratory failure, which we expect to read out next year,” Dr. Hebbar added.
“With the data being presented here at ACG, we see that Auxora continues to deliver across key AP endpoints, showing that the drug substantially reduced respiratory failure, necrotizing pancreatitis, and long hospital stays, which may in turn minimize patient mortality and morbidity as well as the economic burden of this disease,” said Prof. Robert Sutton, University of Liverpool and Liverpool University Hospitals NHS Foundation Trust, chair of the CARPO trial’s steering committee, who will present the CARPO findings at the ACG scientific meeting.
“The reduction of severe respiratory failure is particularly clinically meaningful as respiratory failure is the main driver of mortality in AP patients. These data demonstrate that Auxora may be an important new tool in a critical illness with no approved therapies, and we are encouraged as we look ahead to the Phase 3 trial of Auxora in AP patients with SIRS,” he added.
