CorMedix Inc. announced an agreement with The Leapfrog Group whereby CorMedix Inc. will become a member of the Leapfrog Partners Advisory Committee. The Partners Advisory Committee is a platform for the creation, implementation and evaluation of initiatives that advance the Leapfrog and organizations? alike mission for patient safety and promote a shared accountability for patient safety and well-being.

As a Leapfrog partner, CorMedix will advise the Leapfrog board and management on industry and policy trends and help shape the organization?s long-term strategic vision. Indication and Important Safety Information for DefenCath: DefenCath was approved pursuant to the limited population for antibacterial and antifungal drugs (LPAD) pathway established by the 21st Century Cures Act to address unmet needs of patients with serious bacterial and fungal infections.  In addition, FDA designated DefenCath as a Qualified Infectious Disease Product (QIDP) established by the Generating Antibiotic Incentives Now (GAIN) Act that supports development of antibacterial and antifungal products that treat serious or life-threatening infections. FDA approved DefenCath to reduce the incidence of catheter-related bloodstream infections in adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter.  It is indicated for use in a limited and specific population of patients. The safety and effectiveness of DefenCath have not been established for use in populations other than adult patients with kidney failure receiving chronic HD through a CVC.  DefenCath contains taurolidine, a thiadiazinane antimicrobial and heparin, an anticoagulant, which can induce thrombocytopenia or HIT, and is contraindicated and should not be used in patients with known HIT or hypersensitivity to taurolidine, heparin or citrate. It is not intended for systemic administration.

DefenCath must be aspirated from the catheter and discarded prior to the initiation of the next hemodialysis session. The mean age of patients in LOCK-IT-100 was 61 years, 58% of patients identified as male, 42% identified as female, 63% as white and 30% as black or African-American. Patients with diabetes at baseline accounted for 70% of patients and the mean body mass index was 30.

The majority of patients had been receiving hemodialysis for 12 months or fewer. The location of the CVC was the jugular vein in 92% of patients. The most frequently reported adverse reactions occurring in = 2% of patients in LOCK-IT-100 using DefenCath as a catheter lock solution were hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia.

Adverse reactions leading to death occurred in 5% (18/398) of patients in the DefenCath arm and 5% (21/399) in the heparin arm. Adverse reactions leading to discontinuation of study drug occurred in 17% (69/398) in the DefenCath arm and 18% (72/399) in the heparin arm. The safety and effectiveness of DefenCath have not been established for use in populations other than adult patients with kidney failure receiving chronic hemodialysis through a CVC.

DefenCath is not intended for systemic administration and therefore maternal use is not expected to result in fetal exposure to the drug and breast feeding is not expected to result in exposure of the infant. No animal reproduction study was conducted with DefenCath. The safety and effectiveness of DefenCath have not been established in pediatric patients.

No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients.