CalciMedica Inc. (CALC), a clinical-stage biopharmaceutical company, Thursday announced positive topline data from its Phase 2b study of Auxora, dubbed CARPO, in acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS).
The Phase 2b CARPO trial was intended to establish Auxora's dose-response and efficacy in AP with accompanying SIRS. Patients were randomized into four groups to receive either high, medium or low dose of Auxora or placebo. The primary endpoint of the study was median time to solid food tolerance.
Patients with hyper-inflammatory acute pancreatitis showed a statistically significant dose response with up to 43.6 percent relative reduction in median time to solid food tolerance versus placebo. In patients without hyper-inflammatory AP, Auxora did not show a measurable benefit.
Additionally, Auxora demonstrated a statistically significant dose response with up to 61.7 percent reduction in severe organ failure in all patients versus placebo.
CalciMedica plans to present additional data from CARPO, including results from the analysis of CTs taken at baseline and 30-days post enrollment, at a medical meeting later this year.
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