CalciMedica, Inc. announced late-breaking positive data from its Phase 2b CARPO trial of Auxora in acute pancreatitis (AP) with accompanying systemic inflammatory response syndrome (SIRS) at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. The data showed a statistically significant 100% reduction in new-onset severe respiratory failure (p = 0.0027) and a 64.2% reduction in new-onset persistent respiratory failure (p = 0.0476) in combined high and medium dose Auxora patients compared to combined low dose Auxora and placebo patients.
The trial also demonstrated a statistically significant stratified win ratio of 1.640 (p = 0.0372) for the high dose Auxora compared to placebo. Clinically meaningful reductions were observed for high dose Auxora patients compared to placebo in additional key endpoints, including new-onset necrotizing pancreatitis and time to medically indicated discharge. The high dose of 2.0 mg/kg Auxora was identified as the most effective dose for AP patients.
These results represent a significant step forward for the development of CRAC channel inhibitors in acute critical diseases. CalciMedica plans to meet with the U.S. Food and Drug Administration (FDA) to discuss the design of a Phase 3 trial of Auxora in patients with AP with accompanying SIRS. The company is encouraged by Auxora's unique immunomodulatory action coupled with direct organ tissue protection, particularly in the lung.
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