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8-K - CURRENT REPORT - CorMedix Inc. | crmd_8k.htm |
Exhibit 99.1
CorMedix Revises Timeline and Announces Changes to Lock-It-100
Study Management
Berkeley Heights, NJ – April 27, 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 is in negotiations with its contract research organization
(“CRO”) regarding certain remediation efforts and
financial considerations for the ongoing delay incurred by the
Company in performing the interim efficacy analysis of the
LOCK-IT-100 study. The Company is currently anticipating that the
Data Safety Monitoring Board (“DSMB”) will review the
interim analysis and make its recommendations in July 2018, rather
than in the second quarter, assuming no further significant delays
in obtaining the additional data needed to assess secondary
endpoints and severe adverse events (SAE’s) to complete the
review process are encountered. The Company is assessing the impact
of this delay and the possible outcomes of its CRO discussions on
its anticipated cash needs, and expects to provide an update
as soon as it has the information necessary to accurately assess
such requirements.
Khoso Baluch, President and CEO of CorMedix commented,
“Lapses in data collection on SAE’s and other
requirements for the interim efficacy analysis we discovered have
jeopardized our ability to meet the goals we set and communicated
to our shareholders and business partners with respect to the
timing of the completion of the interim efficacy analysis. We have
therefore brought in-house and assumed direct responsibility for
several aspects of the study, among them site management and review
of SAE’s for the remainder of the study. Our CRO is working
cooperatively with us on the other operational aspects of the
study.”
Mr. Baluch continued, “The integrity of the 28
catheter-related bloodstream infections confirmed by the Clinical
Adjudication Committee (“CAC”) is not in issue. In the
meantime, we have continued to identify and prepare additional
cases of suspected catheter-related blood stream infections for
assessment by CAC as we proceed towards the study’s
conclusion.”
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 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; 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
Contacts:
Dan
Ferry
Managing
Director
LifeSci
Advisors