Ischemix, Inc., a clinical-stage pharmaceutical company focused on hospital-acquired kidney and cardiac injury, announced today that it has completed enrollment in its Phase 2 CARIN trial for prevention of contrast-induced acute kidney injury (CI-AKI) in patients entering the cardiac catheterization lab. Additionally, CARIN is designed to confirm Ischemix' previous successful Phase 2 results in the use of CMX-2043 for prevention of periprocedural cardiac injury in patients receiving cardiac stents (percutaneous coronary intervention or PCI). A total of 361 subjects have been enrolled in the CARIN trial. With the last subject enrolled completing follow-up in mid-December, complete data from the trial is projected to be available in the first quarter of 2016.
David A. DeWahl, Jr., President and CEO of Ischemix said "We are very grateful for the participation of the 31 sites in the US and Canada that enrolled subjects in the trial. We expect that receipt of successful results from the trial would enable us to secure the resources to continue our development plan for CMX-2043."
CARIN is a randomized, double-blind, placebo-controlled trial being conducted to assess the efficacy of CMX-2043 in the prevention of renal and cardiac injury associated with coronary angiography in patients with acute coronary syndrome (ACS) or non-ACS patients undergoing a high risk elective coronary angiography. The primary endpoint of the trial is the prevention of contrast-induced acute kidney injury (CI-AKI). Secondary endpoints include reduction in renal injury as determined by kidney biomarkers, incidence of major adverse cardiac events (MACE) or major adverse kidney events (MAKE) or other clinical complications, reduction in cardiac injury as determined by cardiac biomarkers and reduction in the incidence of Type 4a MI.
"CMX-2043, if ultimately approved for use in prevention of CI-AKI, would address a significant void in the critical care therapeutics marketplace." said Dr. Geoffrey E. Clark, Chief Medical Officer of the Company. "There are no drug therapies currently available to prevent or treat CI-AKI."