CorMedix Inc. (AMEX:CRMD) is a specialty pharmaceutical company that focuses on the licensing and development of therapeutic products for the treatment of cardiac and kidney (cardiorenal) disease. These 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
1. Neutrolin for the prevention of central venous catheter (CVC) infection and Clotting in hemodialysis (HD)
2. Deferiprone for the prevention of contrast induced nephropathy (CIN) in high-risk patients with chronic kidney disease (CKD)
The main focus for Cormedix investors initially will be on 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
Pivotal Study Plan
As mentioned above, Cormedix anticipates starting enrollment H1 2011 for Neutrolin’s prospective, multicenter, double blind, randomized, active comparator study. The study will have approximately 400 patients; study anticipated to be 15 months in duration with the following primary endpoints:
1. Freedom from catheter related bloodstream infection – time to event
2. Duration of time that adequate catheter function is maintained
Initial U.S. launch by CorMedix in HD indication
o Intend to establish Neutrolin as standard of care for HD patients with CVC, expect inclusion on renal guidelines and dialysis providers policy & procedure protocols
Quality of care endorsements for improvement in performance criteria in dialysis networks
o Apply for a J code
o Inclusion in bundle for dialysis as a separately billable drug
Apply for CE mark in EU as soon as quality systems in place
Apply for additional indications for CVCs and PICC lines in non-HD indications
Six (6) issued patents – protection through 2019-2025
Expected Clinical and Regulatory Milestones for CorMedix
1. Neutrolin (CRMD003) (1.35% taurolidine, 4% citrate and 1000u/mL heparin), an antimicrobial catheter lock solution, should receive IDE approval 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 U.S. study is slated to begin 1H11 with interim data anticipated early in 2012.
In addition to Neutrolin, Cormedix has one other ‘near-term’ opportunity in Deferiprone:
2. Deferiprone (CRMD001) is a novel oral, twice-daily formulation of an iron-binding / chelating drug with a Phase 2 study expected to begin 2Q10 with interim data anticipated in 4Q10. 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).
3. CRMD002 – the development and commercialization of a readily available biomarker test for urine labile iron will be supportive to the development and subsequent potential commercialization of Deferiprone (CRMD001).
4. CRMD004 is a novel thixotropic (changes from semi-solid state to free-flowing liquid under pressure generated upon insertion / withdrawal from a catheter) gel formulation in pre-clinical development. CRMD004 could be combined with taurolidine, other antimicrobials, anticoagulants or enzymes for use as a catheter lock solution with the potential to extend the benefits of Neutrolin.
Disclosure: No position