Exhibit
99.1
CORMEDIX INC. COMPLETES REVIEW AND
SOURCE VERIFICATION OF PHASE 3 LOCK-IT 100 DATA FOR
NEUTROLIN®
The Company anticipates Data Safety Monitoring Board Review in July
2018
Berkeley Heights, NJ – June 20, 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 it has completed its review and source-verification of the
data required for the interim analysis of the Phase 3 LOCK-IT 100
study for Neutrolin®. The Company anticipates the database
will be locked shortly and transferred to the independent
biostatistician for unblinding and analysis. The independent
biostatistician will then provide the results to the Data Safety
Monitoring Board (DSMB) for its review, which is expected to occur
in July 2018. The Company is blinded to the results and intends to
remain so until the study concludes.
“We are thrilled to have completed the data collection and
source-verification process for the interim analysis of our Phase 3
LOCK-IT 100 study for Neutrolin, which allows us to proceed with
the next phase of the process. We are focusing on getting the
results of the interim analysis to the DSMB for its review and
recommendation within our most recent announced timeline,”
said Khoso Baluch, Chief Executive Officer of CorMedix. “This
was an arduous process requiring the efforts of 35 senior clincal
research associates, who visited 57 sites and reviewed data for
nearly 700 subjects which had been collected by the sites. While
time consuming, we believe choosing to diligently validate each
data point was the right decision for the study and for the
Company.”
Mr. Baluch continued, “While we continue to accrue additional
potential CRBSI cases in this study, the completion of the data
review and source-verification leads us closer toward our goal of
decreasing the threat of costly and potentially fatal infections
and blood clots, specifically preventing catheter-related blood
stream infections. Even though Neutrolin is approved in Europe,
there is still a great unmet medical need in the U.S. where there
are no pharmacological agents approved yet for CRBSI
prevention.”
The Company plans to submit the interim data to the DSMB in July
and expects a recommendation soon thereafter. While being blinded
to the results of the study, the Company anticipates the DSMB will
offer one of three potential recommendations. The first potential
outcome may be a statistically significant difference between the
Neutrolin and heparin arms, which may allow the conclusion of the
study due to the interim results. The second potential outcome is
that the Company will complete the study as amended and continue
treating subjects until 56 catheter-related blood stream infection
(CRBSI) events are confirmed. The third potential outcome, which
the Company believes unlikely, is that the Company will halt the
trial due to interim results suggesting a positive outcome is
statistically not likely to occur. The Company intends to discuss
with the FDA the results of the interim analysis and the DSMB
recommendations.
In the U.S., Neutrolin is currently under clinical development as
an investigational drug, and its safety and efficacy has not been
evaluated by Food and Drug Administration. In Europe, Neutrolin is
approved as a CE- marked medical device.
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 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, including the interim analysis for the ongoing Phase 3
clinical trial; 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; the possible inability to capture sufficient CRBSI
events in the ongoing Phase 3 clinical trial for
Neutrolin®;
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 Contact:
Dan
Ferry
Managing
Director
LifeSci
Advisors
617-535-7746