CMX-2043 has completed a Phase 1 human safety trial, a Phase 2a trial in the prevention of cardiac injury in PCI patients, and a Phase 2a trial for the prevention of contrast-induced acute kidney injury (CI-AKI) and cardiac injury in renal-compromised patients entering the cardiac catheterization lab.
Ischemix successfully completed a 60-subject Phase 1 safety trial of CMX-2043. The study was designed to assess the safety and tolerability of single escalating IV doses of CMX-2043 compared with placebo. There were no clinically significant effects on vital signs, ECG readings, physical examination findings or clinical laboratory tests for all dose levels.
Ischemix successfully completed a randomized, double-blinded, placebo-controlled 142-patient trial of CMX-2043 at sites in the US and India. Patients entering the hospital for a scheduled PCI were administered an IV injection (at one of three dose levels) of CMX-2043, or a placebo, prior to the commencement of the PCI procedure. Patients entering the trial had normal cardiac enzyme levels upon entry to the trial. Blood levels of the cardiac biomarkers troponin and CK-MB, both well-recognized markers of cardiac cell injury, were measured. Subjects receiving an effective dose of drug had a statistically significant smaller increase in both of these biomarkers after the procedure.
The Company completed a 360-patient prospective, randomized, multi-center, double-blinded, placebo-controlled, Phase 2 Study (CARIN) of the safety and efficacy of CMX-2043 in cardiac catheterization patients at 31 sites in the US and Canada. Endpoints in the trial include reduction in AKI; reduction in periprocedural cardiac injury, incidence of major adverse cardiac events (MACE) and major adverse kidney events (MAKE). The CARIN trial demonstrated safety but did not meet pre-specified endpoints regarding prevention of contrast-induced acute kidney injury (CI-AKI) or cardiac injury in cardiac catheterization lab subjects. The company is now conducting preclinical studies to test the hypothesis that the pharmacokinetics of the drug in the trial were significantly altered by the renal insufficiency status of trial subjects.