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8-K - CURRENT REPORT - CorMedix Inc. | crmd_8k.htm |
Exhibit
99.1
CorMedix Inc. Achieves Target Number of Events in Its LOCK-IT-100
Study of Neutrolin® for Interim Efficacy Analysis
Berkeley Heights, NJ – February , 2018 – CorMedix Inc. (NYSE American: CRMD),
a biopharmaceutical company focused on developing and
commercializing therapeutic products for the prevention and
treatment of infectious and inflammatory disease, today announced
that the Clinical Adjudication Committee (CAC), established to
critically and independently assess catheter-related bloodstream
infections (CRBSIs), has reviewed potential cases of CRBSI in the
Company’s LOCK-IT-100 study of hemodialysis patients with
central venous catheters that occurred through early December 2017,
and identified 28 such cases. As previously agreed with FDA, an
interim analysis will be performed when the first 28 CRBSIs case
have been identified. The primary endpoint for the study is the
reduction of CRBSI by Neutrolin in comparison to a heparin catheter
lock solution.
The Company is currently directing standard procedures to ensure
the accuracy and completeness of the data required for conducting
the interim analysis. This review includes data for all subjects in
the study needed to assess the two secondary endpoints related to a
reduction in catheter removal and catheter blockage, as well as the
primary endpoint and safety information. Before the full dataset
can be locked and the interim analysis can proceed, a number of
weeks will be required to complete the quality assurance procedures
appropriate for the amount of data generated in the trial. The
interim analysis will be provided to the Data Safety Monitoring
Board for its review and recommendation upon completion. The
Company anticipates that DSMB review will occur in the second
quarter of 2018.
Khoso Baluch, Chief Executive Officer of CorMedix stated,
“We are excited about the
progress we are making and look forward to providing further
updates as we achieve the milestones discussed
above.”
LOCK-IT-100 Trial
The Catheter Lock Solution Investigational Trial, or LOCK-IT-100
Trial is a multi-center Phase 3 clinical trial in hemodialysis
patients with central venous catheters in the U.S. It is a
prospective, randomized, double-blind, active control trial
designed to demonstrate the efficacy and safety of Neutrolin in
preventing catheter-related bloodstream infections (CRBSI) in
subjects receiving hemodialysis therapy as treatment for end stage
renal disease. The trial will evaluate whether Neutrolin is
superior to the active control heparin by documenting the incidence
of CRBSI and the time until the occurrence of CRBSI as the primary
endpoint. Key secondary endpoints are catheter patency, which is
defined as required use of tissue plasminogen activator (tPA) or
removal of catheter due to dysfunction and catheter removal for any
reason. LOCK-IT-100 is an event-driven study and study completion
is dependent upon capturing 56 total CRBSI events.
About CorMedix
CorMedix Inc. is a biopharmaceutical company focused on developing
and commercializing therapeutic products for the prevention and
treatment of infectious and inflammatory diseases. The Company is
focused on developing its lead product Neutrolin®,
a novel, non-antibiotic antimicrobial solution designed to prevent
costly and dangerous bloodstream infections associated with the use
of central venous catheters, currently in a Phase 3 clinical trial
enrolling patients undergoing chronic hemodialysis. Such infections
cost the U.S. healthcare system approximately $6 billion annually
and contribute significantly to increased morbidity and mortality.
Neutrolin has FDA Fast Track status and is designated as a
Qualified Infectious Disease Product, which provides the potential
for priority review of a marketing application by FDA and
allows for 5 additional years of QIDP market exclusivity in the
event of U.S. approval. Neutrolin is already marketed as a CE
Marked product in Europe and other territories. In parallel,
CorMedix is leveraging its taurolidine technology to develop a
pipeline of antimicrobial medical devices, with active programs in
surgical sutures and meshes, and topical hydrogels. The
company is also 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,
including with respect to possible uses of taurolidine, 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,
future financial position, financing plans, future revenues and
projected costs should be considered forward-looking. Readers are
cautioned that actual results may differ materially from
projections or estimates due to a variety of important factors,
including: the possible inability to capture sufficient CRBSI
events in the ongoing Phase 3 clinical trial for
Neutrolin®;
the cost, timing and results of the ongoing and planned Phase 3
trials for Neutrolin® in
the U.S. and the resources needed to commence and complete those
trials; the risks and uncertainties associated with
CorMedix’s ability to manage its limited cash resources and
the impact on current, planned or future research, including the
ongoing LOCK-IT 100 trial and research for additional uses for
taurolidine; obtaining additional financing to support
CorMedix’s research and development and clinical activities
and operations; preclinical results are not indicative of success
in clinical trials and might not be replicated in any subsequent
studies or trials; and the ability to retain and hire necessary
personnel to staff our operations appropriately. 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
Contacts:
Dan
Ferry
Managing
Director
LifeSci
Advisors