Several Phase 2 studies varying from 158 to 1,000 CVC patient days showed that Neutrolin® reduced infection rates by between 70 - 100% compared to the control group. By significantly reducing the incidence of CLABSIs, Neutrolin® also:

• Helps prevent inflammatory complications, which are a primary cause of morbidity among end-stage renal disease hemodialysis patients

• Reduces the need for local and systemic antibiotics, which can increase microbial resistance and infection risks

• Reduces the likelihood of catheter failures

• Prolongs catheter life, thus reducing the need for reinsertion procedures

• Reduces hospital lengths of stays

Label Expansion Approved for European Union

Hemodialysis using a tunneled central vein catheter was the initial target market with Germany being the country in which CorMedix launched Neutrolin® as a Class III drug-device combination in December 2013. The label expansion, received in September 2014, includes approval for additional indications of Neutrolin® for use in oncology patients receiving chemotherapy, IV hydration and IV medications via central venous catheters. The expansion also adds patients receiving medication and IV fluids via central venous catheters in intensive or critical care units (cardiac care unit, surgical care unit, neonatal critical care unit, and urgent care centers). An indication for use in total parenteral, or IV, nutrition was also approved.

For more information about Neutrolin® and availability in the European Union, visit CorMedix Europe.

Currently, there are no pharmacological agents approved in the United States for the treatment of catheter related bloodstream infections. 

In the United States

FDA Fast Track and QIDP Designations Granted

In January 2015, the U.S. Food and Drug Administration (FDA) granted Fast Track and Qualified Infectious Disease Product (QIDP) designations for Neutrolin®.

• The Fast Track designation is granted to drug products designed to treat a serious condition, for which clinical data has been generated and shown to potentially address an unmet medical need. The Fast Track designation of Neutrolin provides CorMedix with the opportunity to meet with the FDA on a more frequent basis during the review process, an also ensures an expedited review of any marketing application. 

• In order to achieve QIDP designation, a drug product must be intended to treat serious or life-threatening infections, particularly those infections caused by “qualified pathogens,” as determined by the FDA. These pathogens include Staphylococcus aureus, Streptococcus species and Pseudomonas species, among others. Neutrolin has shown antimicrobial activity against many of these qualified pathogens, several of which are known to pose a serious threat to the public health by causing bloodstream infections in hemodialysis, oncology, and intensive care patients. The QIDP designation provides an additional five years of market exclusivity in addition to the five years granted for a New Chemical Entity.

Yearly, there are over 127 million catheter/dialysis treatment days in hemodialysis patients and 28.5 million catheter days in the critical care/intensive care and oncology units in the United States. There are 250,000 catheter related bloodstream infections (CRBSI) in the U.S., which are also referred to as central line associated bloodstream infections (CLABSI).  Infection and thrombosis represent key complications among critical care/intensive care and cancer patients with central venous catheters. These complications can lead to treatment delays and increased costs to the healthcare system when they occur (due to hospitalizations, need for IV antibiotic treatment, long-term anticoagulation therapy, removal/replacement of the central venous catheter, etc.). Additionally, the mortality rate ranges from 20 to 25 percent.

Phase 3 Program 

CorMedix initiated its pivotal Phase 3 multi-center clinical trial in hemodialysis patients with central venous catheters in the United States. The clinical trial named Catheter Lock Solution Investigational Trial, or LOCK-IT-100 is a prospective, multicenter, randomized, double-blind, placebo-controlled, active control trial which aims to demonstrate the efficacy and safety of Neutrolin in preventing catheter-related bloodstream infections, or CRBSI, in subjects receiving hemodialysis therapy as treatment for end stage renal disease. The primary endpoint for the trial is freedom from CRBSI. The trial will evaluate whether Neutrolin is superior to the active control heparin by documenting the incidence of CRBSI and the time until the occurrence of CRBSI.  Key secondary endpoints are catheter patency which is defined as required use of tissue plasminogen activating factor (tPA) or removal of catheter due to dysfunction and catheter removal for any reason.  An exploratory endpoint of biofilm analysis will be evaluated in the first 200 catheters removed

Second Phase 3 Program Planned

CorMedix plans to conduct a second pivotal Phase 3 clinical trial to support the use of Neutrolin® to prevent catheter related bloodstream infections and is working closely with the FDA to establish the most efficient pathway to potential. At this time, we are discussing a trial designed to enroll 560 oncology patients who are receiving total parenteral nutrition. This clinical trial is expected to commence in 1Q2017. 

The Company has requested for Orphan Drug Designation for pediatric patients on a central venous catheter utilization and for pediatric neuroblastoma stage IV.

CorMedix is evaluating opportunities for the possible expansion of indications for taurolidine. Provisional patents have been submitted in four areas, antimicrobial sutures, nanofiber webs, wound management, and osteoarthritis and visco-supplementation. There exists a need to control and protect against surgical site infections upon closure with sutures. The Company believes taurolidine could offer benefits not currently available in marketed antimicrobial sutures.  CorMedix also believes that the nanofiber webs used for absorbable meshes could benefit from taurolidine’s minimal inflammatory response and infection control. Taurolidine incorporated into webs or hydrogels could also be used for wound management especially wounds in less sterile environments and burn patients. Lastly, incorporating taurolidine into formulations for osteoarthritis and visco-supplementation may benefit from taurolidine’s anti-inflammatory and anti-infection properties.