CorMedix reports encouraging interim results from CRMD001 phase II study in Contrast Induced Acute Kidney Injury

CorMedix Inc.Apr 1 2011

CorMedix Inc. ("CorMedix") (NYSE Amex: CRMD), a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, today announced its interim analysis and clinical update for CRMD001. The study is a phase II, randomized, double blind, placebo-controlled trial to assess the efficacy and safety of proprietary formulations of deferiprone (CRMD001) in preventing Contrast Induced Acute Kidney Injury ("CI-AKI") in high risk patients who have chronic kidney disease ("CKD") and are undergoing coronary angiography with the intent of adjunctive percutaneous coronary intervention and receiving an iodinated radiocontrast agent.

“We look forward to continuing our Phase II study in preventing CI-AKI, which is a serious medical issue in a high risk patient population and to have the potential of being the first approved therapeutic in this area.”

"We are encouraged by the interim analysis and CRMD001's apparent safety profile, and look forward to providing final safety and efficacy results during the second half of 2011," stated John C. Houghton, President and Chief Executive Officer. "We look forward to continuing our Phase II study in preventing CI-AKI, which is a serious medical issue in a high risk patient population and to have the potential of being the first approved therapeutic in this area."

The Phase II study began enrolling patients in June 2010 and the Company plans to enroll 60 patients (30 per arm) in approximately 8 centers across the United States by the end of the first half of 2011.

The interim analysis involved a review, by an independent unblinded statistician, of the biomarker data to enable sample size re-estimation. The Company and all other participants are blinded and will remain blinded until the end of the study.

Key Findings of the Interim Analysis and Clinical Update Are as Follows:

• The Phase II study is evaluating the effect of CRMD001 on kidney function and acute kidney injury by measuring changes from baseline in the following biomarkers: serum cystatin C; urinary NGAL("Neutrophil Gelatinase Associated Lipocalin"):Cr and LFABP ("Liver Fatty Acid Binding Protein"):Cr ratios within 192 hours of exposure. Based upon the independent statistician's assessment, the interim biomarker analysis of the first 30 patients indicates the Company should continue to enroll 60 patients as planned in the protocol.
• Proprietary oral formulations of deferiprone (CRMD001) given twice daily as one 900 mg immediate release tablet and two 900 mg extended release tablets over 8 days appears to have a favorable safety profile as assessed by a blinded review of accumulating safety data. A total of 38 patients have been enrolled by 6 sites with 5 reported Serious Adverse Events which are not considered to be drug related by the investigators.

A full pharmacokinetic analysis and biomarker evaluation is expected to be performed during the second half of 2011. The evaluation will again be performed by an independent statistician.

Currently, the standard of care to prevent CI-AKI in high risk patients with CKD is hydration and avoidance of nephrotoxic drugs and dehydration. There is no single therapeutic intervention that has conclusively and consistently proven to be effective in the prevention of CIN, and there are no FDA-approved preventative treatments.