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 has received a Special Protocol – Agreement letter from the U.S. Food and Drug Administration (“FDA”) regarding a Special Protocol Assessment (“SPA”) on the design of a pivotal Phase 3 trial for the Company’s oral formulation of CRMD001 in the prevention of Contrast-Induced Acute Kidney Injury (“CI-AKI”). This SPA takes into consideration a modification to the dosing regimen contained in the previously submitted protocol.
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 Phase 3 clinical study of CRMD001 to be conducted under the SPA is planned for approximately 800 patients in approximately 80 centers worldwide. The planned study will be randomized, double-blind and placebo-controlled, with patients evenly divided into two groups: CRMD001 and placebo. The study will assess the efficacy and safety of CRMD001 in the reduction of morbidity and mortality in patients with CKD undergoing diagnostic or interventional cardiac procedures and receiving an iodinated radiocontrast agent. The study will have a primary composite clinical endpoint that includes: death, dialysis, myocardial infarction, stroke, congestive heart failure and hospitalization. The hypothesis is that CRMD001 will significantly reduce the composite event rate compared to placebo. The study also includes secondary and exploratory endpoints which will include changes in serum creatinine and serum cystatin C, as well as other biomarkers. CRMD01 or placebo will be administered orally for 8 days.
CorMedix plans to begin patient enrollment in this Phase 3 study during the first half of 2012, pending results of its Phase 2 study for which patient recruitment was recently completed; results of such Phase 2 study are expected to be reported in the second half of 2011.