CalciMedica’s Auxora shows efficacy in Acute Pancreatitis Phase 2b trial

CalciMedica announced positive topline data from CARPO, the company’s Phase 2b trial evaluating Auxora for the treatment of acute pancreatitis with accompanying systemic inflammatory response syndrome. The trial established a dose response for Auxora across multiple endpoints, identified both the target patient population and the likely drug dose for a pivotal trial, and re-affirmed Auxora’s safety profile and tolerability as seen in prior clinical trials. CARPO met its study objective by showing a dose response for time to solid food tolerance as well as other clinical endpoints. The primary endpoint of median time to solid food tolerance in the pre-specified subgroup of patients with hyper-inflammatory acute pancreatitis showed a statistically significant dose response with placebo patients requiring 4.7 days to tolerate solid food and patients in the high dose group showing a 1.9 day improvement vs. placebo, the medium dose group a 2.1 day improvement and the low dose group a 1.5 day improvement. In patients without hyper-inflammatory AP, Auxora did not show a measurable benefit. Additionally, Auxora demonstrated a statistically significant dose response in reduction of severe organ failure. Auxora was well-tolerated. There were no deaths in the high dose or low dose group. CalciMedica intends to present additional data from CARPO at a medical meeting later this year.