Exhibit 99.1
CORMEDIX INC. ANNOUNCES FDA MEETING UPDATE
Cleared to Request Approval under LPAD; FDA to Review LOCK-IT-100
Clinical Data
Berkeley Heights, NJ – February 14, 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
that it has begun discussions with the U.S. FDA regarding its
recently completed and unblinded Phase 3 LOCK-IT-100 study to
support regulatory approval for Neutrolin®, the
Company’s investigational product under development as a
catheter lock solution for patients suffering from end stage renal
disease undergoing hemodialysis.
At the meeting, the FDA agreed that the Company could request
consideration of Neutrolin for approval under the LPAD (Limited
Population Pathway for Antibacterial and Antifungal Drugs)
pathway.
Data originally submitted to the FDA included preliminary analyses
from 653 subjects at the time of the interim analysis, including
the first 28 cases of catheter-related blood stream infection
(CRBSI). Because the study continued enrolling and treating
subjects until study termination in August 2018, the full data set
is based on a total of 795 subjects and 41 CRBSI events, as
determined by the Clinical Adjudication Committee. The Company
announced the topline results of the full data set of LOCK-IT-100
on January 30, 2019 shortly after the study data was
unblinded.
The Company agreed at the meeting to provide FDA a detailed
analysis of the full data set including secondary endpoints from
the LOCK-IT-100 study to facilitate FDA’s consideration of
CorMedix’s request to file the New Drug Application (NDA) for
Neutrolin on the basis of the LOCK-IT-100 study results. These data
became available following the locking and unblinding of the study
data in late January 2019. The analysis is planned to be completed
over the next few months.
Khoso Baluch, President and CEO
of CorMedix, commented, “We believe our meeting with the FDA
was very productive and we look forward to continuing discussions
with them on whether LOCK-IT-100 is adequate to support the NDA
submission. We understand
FDA’s desire to assess the full data set. We will continue to
pursue our goal of filing the NDA based on the single study, and
appreciate the guidance received from the
FDA.”
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 results of our discussions with the FDA regarding
the Neutrolin development path; 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