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.
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 catheters in patients undergoing chronic hemodialysis. DefenCath has been designated by FDA as Fast Track and as a Qualified Infectious Disease Product (QIDP), and the original New Drug Application (NDA) received priority review in recognition of its potential to address an unmet medical need. QIDP provides for an additional five years of marketing exclusivity, which will be added to the five years granted to a New Chemical Entity upon approval of the NDA. CorMedix also committed to conducting a clinical study in pediatric patients using a central venous catheter for hemodialysis when the NDA is approved, which will add an additional six months of marketing exclusivity when the study is completed. CorMedix received a second Complete Response Letter from the FDA last August related to deficiencies at both its primary contract manufacturer and its supplier of heparin API. 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. CorMedix also intends to develop DefenCath as a catheter lock solution for use in other patient populations, and the Company is working with top-tier researchers to develop taurolidine-based therapies for rare pediatric cancers. For more information visit: www.cormedix.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are subject to risks and uncertainties. All statements, other than statements of historical facts, regarding management’s expectations, beliefs, goals, plans or CorMedix’s prospects, including, but not limited to, CorMedix’s future financial position, financing plans, future revenues, projected costs and the sufficiency of our cash and short-term investments to fund our operations should be considered forward-looking statements. Readers are cautioned that actual results may differ materially from projections or estimates due to a variety of important factors, including: the risks and uncertainties related to market conditions; the ability to secure final FDA approval prior to July 1, 2024; CorMedix’s ability to manage its cash resources and the impact on current, planned or future research; the ability to achieve commercial preparedness ahead of the target action date in November 2023; and that preclinical results are not indicative of success in clinical trials and might not be replicated in any subsequent studies or trials. These and other risks are described in greater detail in CorMedix’s filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements, except as required by law.