Business
CorMedix Inc. Announces Publication of Phase 3 LOCK IT-100 Study Data in the Clinical Journal of The American Society of Nephrology
BERKELEY HEIGHTS, N.J., Sept. 08, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing
About this update from Cormedix Inc.
[{"type":"text","content":"BERKELEY HEIGHTS, N.J., Sept. 08, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today 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 (CRBSIs) in study subjects receiving hemodialysis via central venous catheter (CVC). 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. “The publication of these phase 3 data in a highly respected peer-reviewed nephrology publication like CJASN demonstrates the importance of these clinical results in addressing the unmet medical need of CRBSIs,” said Joseph Todisco, Chief Executive Officer of CorMedix. “This further validates the potential of DefenCath to have a meaningful impact on patient outcomes as well as address overall healthcare costs caused by the high incidence of CRBSI in the hemodialysis community.” 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 (PDUFA) target action date of November 15, 2023. About CorMedix CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on developing its lead product DefenCath®, a novel, non-antibiotic antimicrobial solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous cathet...