Blueprint
Exhibit 99.1
CORMEDIX INC. ANNOUNCES TOPLINE ANALYSIS OF THE FULL DATA SET OF
PHASE 3 LOCK-IT-100 STUDY REINFORCES THE INTERIM RESULTS
Berkeley Heights, NJ – January 30, 2019 – 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
the topline results of the full data set of the Company’s
Phase 3 LOCK-IT-100 study for Neutrolin® as a catheter lock
solution in hemodialysis patients. The Company recently announced
the topline results from the interim analysis of the study, which
was terminated in August 2018 following the recommendation of the
independent Data Safety Monitoring Board (DSMB), because efficacy
had been demonstrated and the pre-specified level of statistical
significance had been achieved.
Efficacy data were available from 653 subjects at the time of the
interim analysis, including the first 28 cases of catheter-related
blood stream infection (CRBSI). However, because the study
continued enrolling and treating subjects until study termination,
the final efficacy analysis was based on a total of 795
subjects.
The primary endpoint of the Phase 3 LOCK-IT-100 study was the
reduction of the risk of occurrence of CRBSI by Neutrolin relative
to the active control of heparin. CRBSI frequently result in
hospitalization and admission to the intensive care unit, and may
potentially cause death. In the analysis of the full data set, a
total of 41 CRBSI events were determined by the Clinical
Adjudication Committee (CAC). There was a 71% reduction in the risk
of occurrence of CRBSIs compared with the active control of
heparin, which is well in excess of the study’s assumed
treatment effect size of a 55% reduction. In the Neutrolin arm, the
CRBSI event rate was 0.13 per 1000 catheter days, which is
significantly lower than the event rate of 0.46 per 1000 catheter
days in the control arm. The statistical significance of the
primary endpoint in the full data set (p=0.0006) was even more
impressive than that of the interim analysis
(p=0.0034).
There were no statistically significant differences between the
results in the Neutrolin arm compared with the control arm in the
final analysis for the secondary endpoints. The event rate for one
of the secondary endpoints, catheter removal for any reason, was
3.48 per 1,000 catheter-days (236 out of 397 subjects) in the
Neutrolin arm and 3.23 per 1,000 catheter-days (224 out of 398
subjects) in the control arm (p=0.39).
The loss of catheter patency, which was defined either as catheter
removal due to loss of catheter patency or the administration
of tissue plasminogen
activating factor (tPA), was
also a secondary endpoint. The event rate for loss of catheter
patency was 1.01 per 1,000 catheter-days (64 out of 397 subjects)
in the Neutrolin arm and 0.74
per 1,000 catheter-days (48 out of 398 subjects) in the control arm
(p=0.10).
In the top-line safety analysis, the observed rate of
treatment-emergent adverse events was lower in the Neutrolin arm.
The rate of adverse events per patient was 5.1 in the Neutrolin arm
and 5.8 in the control arm.
“We are extremely pleased that the analysis of the primary
endpoint of the full data set of LOCK-IT-100 confirms and
reinforces the results of the interim analysis,” said
Khoso Baluch, Chief Executive Officer. “These data add to the
growing body of evidence supporting our conclusion that Neutrolin
prevents CRBSIs from central venous catheters of patients with end
stage renal disease undergoing hemodialysis. We
expect to share more information as the analyses of the study data
progresses over the coming months.”
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 Phase 3 development for
patients undergoing chronic hemodialysis. Such infections have
significant treatment costs and lead to increased morbidity and
mortality. Neutrolin has FDA Fast Track status and is designated as
a Qualified Infectious Disease Product, which provide the potential
for priority review of a marketing application by FDA and
allow for a total of ten years of 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
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 resources needed to complete the information
required to submit a new drug application for Neutrolin to the FDA;
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 continued
development of Neutrolin 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 Contact:
Dan
Ferry
Managing
Director
LifeSci
Advisors
617-535-7746