CalciMedica Announces Topline Data From Phase 2b CARPO Trial Of Auxora In Acute Pancreatitis; Primary Objective Of The Trial Met With Statistically Significant Dose Response With Up To 43.6% Relative Reduction
Primary objective of the trial met with statistically significant dose response with up to 43.6% relative reduction (2.1 day improvement) in median time to solid food tolerance versus placebo in hyper-inflamed patients
Statistically significant dose response with up to 61.7% reduction in severe organ failure in all patients versus placebo
Up to 100% reduction in hospital stays longer than 21 days
Planning End-of-Phase 2 meeting with the FDA in preparation for a pivotal trial
Conference call to discuss the CARPO topline results scheduled for 8:30 a.m. ET today
LA JOLLA, Calif., June 27, 2024 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica") (NASDAQ:CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today announced positive topline data from CARPO, the Company's randomized, double-blind, placebo-controlled Phase 2b trial evaluating Auxora™ for the treatment of acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS). 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.