CorMedix Inc. Announces Publication of Phase 3 LOCK IT-100 Study Data in the Clinical Journal of The American Society of Nephrology
08 Septiembre 2023 - 7:30AM
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 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.
Forward-Looking Statements
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.
Investor Contact:Dan FerryManaging
DirectorLifeSci Advisors(617) 430-7576
CorMedix (NASDAQ:CRMD)
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