N.J. Pharma Firm Testing Kidney Drug In Mich.
Bridgewater, N.J.-based CorMedix Inc. (NYSE Amex: CRMD) said Friday that it is conducting a study of a new drug for kidney disease at Providence Hospital and Medical Center in Southfield and Northern Michigan Regional Hospital in Petoskey.
CorMedix said Friday that it had dosed its first patient with CRMD-001, a proprietary formulation of deferiprone, in a randomized, double-blind, placebo-controlled clinical trial.
This Phase II proof-of-concept study is for the prevention of contrast-induced acute kidney injury in approximately 60 high-risk patients with chronic kidney disease and additional risk factors, who are undergoing coronary angiography with the intent of adjunctive percutaneous coronary intervention.
The primary objective of this trial is to assess the impact of the oral iron chelator, CRMD-001, on sensitive biomarkers of contrast-induced acute kidney injury in this high-risk patient population with CKD. In addition, the study will assess the safety and tolerability of CRMD-001 for short-term use.
Patients will be randomized to receive either CRMD-001 or placebo, and they will be dosed orally for 8 days, starting immediately prior to coronary angiography. Biomarker, safety and clinical endpoints will be assessed through 90 days.
"There may be a significant opportunity for CRMD-001 to fulfill the unmet medical need of preventing contrast-induced nephropathy in high-risk patients, and we look forward to generating compelling clinical data," said Peter A. McCullough, M.D., principal investigator of the study.
Said Sudhir V. Shah, M.D., a member of CorMedix's scientific advisory board: "The collective evidence for the role of labile iron in kidney and heart diseases is quite overwhelming. Based upon deferiprone's well-characterized efficacy in reducing excess labile iron, we believe it will provide protection against contrast-induced acute kidney injury and associated cardiovascular complications."
Contrast-induced nephropathy (acute kidney injury), or CIN, is a common and potentially serious complication arising from the use of iodinated contrast media. CIN is most commonly defined as a new onset or exacerbation of renal dysfunction after contrast administration without other identifiable causes. It is the third most common cause of hospital-acquired renal insufficiency after low blood pressure and major surgery. It is associated with increased mortality, cardiovascular complications (myocardial infarction, stroke, heart failure, etc.), increased dialysis, permanent kidney damage, and delayed discharge/re-hospitalization.
CRMD-001 is CorMedix's formulation of deferiprone, an oral iron chelator that has well-documented efficacy and safety in iron-overload disorders. Deferiprone is currently available in more than 50 countries outside the United States for other indications. The current Phase II proof-of-concept study is the first to evaluate the efficacy and safety of CRMD-001 in cardiorenal disorders. The prevention of contrast-induced acute kidney disease in this targeted high-risk group is an orphan-sized population.
CorMedix Inc. is a pharmaceutical company that seeks to in-license, develop and commercialize therapeutic products for the prevention and treatment of cardiac and renal dysfunction, also known as cardiorenal disease. CorMedix's goal is to treat kidney disease by reducing the commonly associated cardiovascular and metabolic complications, in effect, treating the kidney to treat the heart. More at www.cormedix.com.
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