CorMedix announces publication of Phase 3 LOCK IT-100 study data

CorMedix announced the publication of its Phase 3 LOCK IT-100 study results in the Clinical Journal of the American Society of Nephrology, or CJASN. The study compared the efficacy and safety of DefenCath, a catheter lock solution that combines taurolidine 13.5 mg/mL and heparin 1000 USP units/mL, versus heparin alone, in preventing Catheter Related Bloodstream Infections in study subjects receiving hemodialysis via central venous catheter. The randomized, double-blind, active control, Phase 3 study included 795 subjects with kidney failure undergoing hemodialysis via CVC from 70 U.S. sites. As previously presented, DefenCath demonstrated a statistically significant 71% reduction in risk of developing a CRBSI in subjects receiving hemodialysis via CVC with a comparable safety profile to heparin alone. Supported by the LOCK IT-100 study results, CorMedix is pursuing FDA approval of DefenCath. After receiving guidance from FDA at a Type A meeting in April of 2023, the NDA for DefenCath was resubmitted. In June of 2023, the resubmitted NDA was accepted for filing by the FDA and assigned a Prescription Drug User Fee Act target action date of November 15, 2023.