COVID-19 Information

FDA Grants CalciMedica Permission to Begin Dosing CM4620-IE in Patients with Severe COVID-19 Pneumonia under a Newly Opened IND 

  • Regions Hospital in St. Paul, Minnesota has begun a Phase 2 clinical study of CM4620-IE in patients with severe COVID-19 pneumonia who develop hypoxemic respiratory failure and are at risk for progression to acute respiratory distress syndrome, and Henry Ford Hospital in Detroit is expected to begin shortly after

  • CM4620-IE is a potent and selective small molecule that may prevent pulmonary endothelial damage and lessen the cytokine storm in COVID-19

  • CM4620-IE has demonstrated clinical safety and potential efficacy in patients with hypoxemia secondary to systemic inflammatory response syndrome in the setting of acute pancreatitis

  • The open-label Phase 2a clinical trial aims to enroll 60 patients with severe COVID-19 pneumonia and a PaO2/FiO2≤300, patients who are risk to progress to mechanical ventilation. Forty patients will be assigned to CM4620-IE plus standard of care and 20 assigned to standard of care alone. The therapy will be delivered intravenously with the aim of keeping COVID-19 patients with severe pneumonia, whose breathing is rapidly declining, from “crashing” and needing ventilators by decreasing inflammation in the lungs. 

 

Stage
Phase 2
Company Type
Late Onset Intervention