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CalciMedica Announces Positive Topline Data from Phase 2b CARPO Trial of Auxora™ in Acute Pancreatitis (AP)
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
About this update from Calcimedica, Inc.
[{"type":"text","content":"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 \nStatistically significant dose response with up to 61.7% reduction in severe organ failure in all patients versus placebo \nUp to 100% reduction in hospital stays longer than 21 days\nPlanning End-of-Phase 2 meeting with the FDA in preparation for a pivotal trial\nConference call to discuss the CARPO topline results scheduled for 8:30 a.m. ET today\nLA 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.\n\n \n \n \n \n \n \n\n \n\"With these results, CARPO has added significantly to the body of evidence showing Auxora's potential as an effective treatment for critically ill patients with acute inflammatory disease and warrants advancing our drug in both AP and acute kidney injury,\" said Rachel Leheny, Ph.D., Chief Executive Officer of CalciMedica. \"We plan to move quickly towards initiating our Phase 3 trial in AP and are eager to engage with the FDA to discuss our trial plans once we have all the data from CARPO. We look forward to unlocking Auxora's potential to treat these patients who have few treatment options.\"\n\"There are currently no drugs for the treatment of AP and the CARPO data show a benefit in multiple endpoints, supporting the need for Auxora,\" said Joseph Miller, M.D., Clinical Associate Professor of Emergency Medicine at Henry Ford Health and Michigan State University and Associate Director Emergency Care Research at Henry Ford Health and a prin...