CorMedix Inc. ("CorMedix") (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, announced it successfully completed patient enrollment in its phase II Contrast-Induced Acute Kidney Injury ("CI-AKI") study with its oral drug candidate CRMD001.
CI-AKI, also referred to as Contrast Induced Nephropathy ("CIN"), with its associated morbidity and mortality each year afflicts about one-third of the approximate 325,000 high risk patients with Chronic Kidney Disease ("CKD") in the U.S. who undergo angiography for vascular imaging. If effective, CRMD001 treatment could significantly reduce the occurrence of CIN and its complications.
The double blind, placebo-controlled randomized phase II study evaluates the safety and efficacy of CRMD001 on biomarkers of acute kidney injury and kidney function. The study was conducted in high risk patients who have CKD and are undergoing a coronary angiography and receiving an iodinated radiocontrast agent. CorMedix expects to report final results before year-end.
Commenting on the study, CorMedix President and CEO, John C. Houghton, stated, "We are very pleased to have successfully completed patient enrollment in our Phase II study, for an indication which has no approved therapeutic treatment. We are eagerly awaiting the results."
Currently, the standard of care to prevent CI-AKI in high risk patients with CKD is hydration and avoidance of nephrotoxic drugs. There is no single therapeutic intervention that has conclusively and consistently proven to be effective in the prevention of CI-AKI, and there are no FDA-approved preventative treatments.
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