Exhibit 99.1
CORMEDIX INC. ANNOUNCES POSITIVE RESULTS OF ITS NEUTROLIN®
PHASE 3
LOCK-IT-100 STUDY BASED ON RECOMMENDATION BY INDEPENDENT
DATA
SAFETY MONITORING BOARD
Statistical Significance Achieved at Interim Analysis
Berkeley Heights, NJ – July 25, 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 independent Data
Safety Monitoring Board (DSMB) has completed its review of the
interim analysis of the data from the currently ongoing Phase 3
LOCK-IT-100 study for Neutrolin®. Because the pre-specified
level of statistical significance was reached and efficacy had been
demonstrated, the DSMB recommended the study be terminated early.
No safety concerns were reported by the DSMB based on the interim
analysis. The company will submit the results of the interim
analysis to the U.S. Food and Drug Administration for its
review.
“We are thrilled to have received the DSMB’s
recommendation that efficacy has been demonstrated. Once we have
submitted the interim analysis results and DSMB’s
recommendation to the FDA, we will begin the dialogue on the
appropriate next steps,” said Khoso Baluch, Chief Executive
Officer of CorMedix. “We have invested a significant amount
of the Company’s resources over the last 2 ½ years in
this study, and it is gratifying to have achieved this result based
on the interim analysis. We believe Neutrolin has great potential
to save lives of patients receiving hemodialysis therapy as a
treatment for end stage renal disease and to lower overall
healthcare costs due to reducing the risk of catheter-related blood
stream infections (CRBSI).”
The primary endpoint of the Phase 3 LOCK-IT-100 study is reducing
the risk of occurrence of CRBSI
by Neutrolin relative to the active control of heparin. The
secondary endpoints are catheter patency, which is defined as
required use of tissue plasminogen activating factor (tPA) or
removal of catheter due to dysfunction, and catheter removal for
any reason.
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, in a Phase 3 clinical trial enrolling
patients undergoing chronic hemodialysis that will be terminated
early for efficacy. 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 the LOCK-IT-100 trial, 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 terminate the Phase 3 trial and the costs and
time needed to submit a new drug application to the FDA; risks
related to obtaining FDA approval of the new drug application for
Neutrolin; 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; relying on preclinical results that may not be
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