CalciMedica Announces Positive Topline Data from Phase 2b CARPO Trial of Auxora™ in Acute Pancreatitis (AP)

Core Insights - The CARPO trial met its primary objective, demonstrating a statistically significant dose response with a 43.6% relative reduction in median time to solid food tolerance in hyper-inflamed patients compared to placebo [1][4] - Auxora showed a 61.7% reduction in severe organ failure across all patients versus placebo [1][5] - The trial also indicated a 100% reduction in hospital stays longer than 21 days for high dose patients [1] Company Overview - CalciMedica Inc. is a clinical-stage biopharmaceutical company focused on developing CRAC channel inhibition therapies for inflammatory and immunologic diseases [12][15] - The lead compound, Auxora, is being evaluated for acute pancreatitis (AP) and acute kidney injury (AKI) among other conditions [12][15] Trial Details - The Phase 2b CARPO trial was a randomized, double-blind, placebo-controlled study with 216 patients, assessing Auxora's efficacy in treating AP with systemic inflammatory response syndrome (SIRS) [3][4] - Patients were divided into four groups receiving different doses of Auxora or placebo, with treatment lasting for 30 days [3] Efficacy Data - In hyper-inflammatory acute pancreatitis patients, the median time to solid food tolerance improved by 1.9 days (high dose), 2.1 days (medium dose), and 1.5 days (low dose) compared to placebo [4][5] - Severe organ failure rates were significantly lower in high and medium dose groups, with a 59.6% and 61.7% relative risk reduction respectively compared to placebo [5][6] Safety Data - Auxora was well-tolerated, with fewer treatment-emergent serious adverse events (TESAEs) reported in the high and medium dose groups compared to placebo [7] - No drug-related TESAEs were reported in the high dose group, and only one in the low dose group [7] Future Plans - The company plans to engage with the FDA for an End-of-Phase 2 meeting and is preparing for a pivotal trial [1][2] - Additional data from the CARPO trial will be presented at a medical meeting later this year [9]