CorMedix Inc. (AMEX:CRMD), a specialty pharmaceutical company that focuses on the licensing and development of therapeutic products for the treatment of cardiac and kidney (cardiorenal) disease, on Friday announced dosing of the 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 (CKD) and additional risk factors, who are undergoing coronary angiography with the intent of adjunctive percutaneous coronary intervention (PCI).
Recall that CorMedix product candidates include a risk-mitigated clinical development profile, target significant niche markets, and have a relatively low cost of development through potential commercialization. Cardiorenal disease includes a broad range of inter-related cardiovascular, kidney and metabolic conditions.
CorMedix has two Products entering late stage clinical development
- Neutrolin for the prevention of central venous catheter (CVC) infection and Clotting in hemodialysis (HD)
- Deferiprone for the prevention of contrast induced nephropathy (CIN) in high-risk patients with chronic kidney disease (CKD). Deferiprone (CRMD001) is a novel oral, twice-daily formulation of an iron-binding / chelating drug that was expected to begin Friday’s announced Phase II study in 2Q10 interim data anticipated in 4Q10.
Friday’s announced Phase II study is currently being conducted at two study centers in the United States: Providence Hospital and Medical Center in Southfield, MI and Northern Michigan Regional Hospital in Petoskey, MI.
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 shortterm 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.
This trial will likely be followed by a larger, pivotal Phase 3 study under a Special Protocol Assessment (SPA) with the FDA. Deferiprone is being developed for the treatment of contrast induced nephropathy (kidney damage associated with medical imaging procedures).
“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,” stated Peter A. McCullough, MD, MPH, Principal Investigator of the study.
Of course, the main focus for Cormedix investors remains lead product candidate Neutrolin (CRMD003) (1.35% taurolidine, 4% citrate and 1000u/mL heparin), an antimicrobial catheter lock solution is anticipated to be ready for IDE submission to proceed to a pivotal study to support a future FDA medical device submission for marketing approval in the U.S. (PMA), as well as CE Mark clearance in Europe by year-end.
The pivotal US study is slated to begin 1H11 with interim data anticipated early in 2012. Neutrolin combines the anti-coagulants (citrate and heparin) and the antimicrobial (taurolidine) in a liquid formulation to fill or “lock” central venous catheters (CVC). The initial indication for Neutrolin will be in HD patients with CVCs. However, there are several other potential uses including intensive care, total parenteral nutrition (TPN) and CVCs for delivery of chemotherapy agents.
The Market Opportunity for Neutrolin is anything but small for those of you who have never worked in an acute care (hospital setting): 80,000 HD catheter patients in the U.S., representing 12.5 million HD sessions per year. CVCs are subject to clotting and are associated with catheter-related bloodstream infection (CRBI). There are 160,000 CRBI episodes in the U.S. alone, 6,000 die annually, and the cost to US healthcare system is (roughly) an astounding $1 billion. The current standard of care (heparin) does not prevent CRBI.
Neutrolin for Prevention of CRBI will be supplied via catheter lock solution for the prevention of CRBI and maintenance of catheter function in HD patients. The solution will contain Taurolidine, a broad-spectrum antimicrobial, targeted to prevent infection and formation of biofilm. Unlike other antibiotics, there has been no observed bacterial resistance to Taurolidine – unlike antibiotics (>14,000 patients exposed), no systemic toxicity at levels 650x the amount contained in 5mL of Neutrolin. The lock solution also contains citrate and heparin as anti-coagulants to prevent thrombus formation and clotting (which is per normal use in the hospital). It is safe and well tolerated. No adverse events (AE’s) related to Neutrolin in catheter lock studies involving ~300 patients
Disclosure: No positions