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8-K - CURRENT REPORT - CorMedix Inc. | crmd_8k.htm |
Exhibit
99.1
CORMEDIX INC. ANNOUNCES HIGHLY STATISTICALLY SIGNIFICANT TOPLINE
RESULTS FOR NEUTROLIN® FROM THE INTERIM ANALYSIS OF THE PHASE
3 LOCK-IT-100 STUDY
Conference Call today at 4:30 p.m. Eastern Time
Berkeley Heights, NJ – January 17, 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 interim analysis of the Company’s
Phase 3 LOCK-IT-100 study for Neutrolin® as a catheter lock
solution in hemodialysis patients. As previously announced, the
study was terminated at the recommendation of the independent Data
Safety Monitoring Board (DSMB) after the interim analysis was
completed in July 2018, because efficacy had been demonstrated and
the pre-specified level of statistical significance had been
achieved. The DSMB reported that there were no safety
concerns.
In the Neutrolin arm, there was a 72% reduction in the risk of
occurrence of catheter-related blood stream infections (CRBSI),
which was the primary endpoint of the study, compared with the
active control of heparin. The interim analysis was conducted, as
pre-specified, when the results of the first 28 cases of CRBSIs
were available. The interim analysis of these cases showed that the
72% reduction of CRBSI by Neutrolin was well in excess of the
study’s assumed treatment effect size of a 55% reduction. The
impressive treatment effect of Neutrolin was highly statistically
significant (p=0.0034). The DSMB also reviewed the available safety
data and identified no concerns. CorMedix remained blinded to the
results of the interim analysis until after the database was
recenty locked at study completion.
“This is tremendous news for the individuals who use central
venous catheters for their dialysis treatments,” said Khoso Baluch, Chief Executive Officer.
“Catheter-related bloodstream infections in subjects
receiving hemodialysis therapy as a treatment for end stage renal
disease is a potentially deadly risk, and these results from
LOCK-IT-100 demonstrate that Neutrolin has the potential to
meaningfully save lives and lower overall healthcare costs.
CorMedix is grateful to the study subjects and investigators who
participated in LOCK-IT-100.”
Conference Call Information:
CorMedix CEO, Khoso Baluch will host a conference call and webcast
today, January 17, 2019, at 4:30 PM Eastern Time, to discuss the
topline results of the Company’s Phase 3 LOCK-IT-100 study.
Call details and dial-in information are as follows:
Thursday, January 17 at 4:30pm Eastern Time
Domestic:
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877-407-9124
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International:
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201-689-8584
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Conference ID
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13686731
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Webcast
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https://www.investornetwork.com/event/presentation/42196
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Replays, available through February 17, 2019:
Domestic:
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877-481-4010
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International:
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919-882-2331
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Replay Passcode:
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42196
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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 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
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