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8-K - CURRENT REPORT - CorMedix Inc. | crmd_8k.htm |
Exhibit 99.1
CORMEDIX INC. REPORTS PROGRESS ON LOCK-IT 100 DATA REVIEW AND
APPOINTS PAUL CHEW AS CONSULTANT ADVISOR CMO
●
More than 75% of key data for
Neutrolin®
Phase 3 LOCK-IT 100 reviewed and
source-verified for pre-planned
interim analysis
●
Dr. Paul Chew, cardiologist and seasoned biopharmaceutical
executive appointed as Consultant Advisor CMO
Berkeley Heights, NJ – May 29, 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 Company’s clinical operations team has reviewed and
source-verified more than 75% of data for the interim analysis of
the Phase 3 LOCK-IT 100 study for Neutrolin®. The pace of
source verification continues to accelerate, and the Company is on
schedule to complete this work by the end of June
2018.
Neutrolin is currently under clinical development in the U.S. as an
investigational drug and its safety and efficacy has not been
evaluated by FDA. In Europe, Neutrolin is approved as a CE-marked
medical device.
“We have made significant progress on our data collection
efforts for our Phase 3 LOCK-IT 100 study for Neutrolin. In the
last two weeks alone we have increased the percentage of data
reviewed and source verified from 54% to 75%,” said Liz
Masson, EVP Head of Clinical Operations. “Our focus remains
to ensure that all the required data for the interim analysis is
correct and source-verified as quickly as
possible.”
Khoso Baluch, Chief Executive Officer of CorMedix commented,
“We look forward to providing more updates as we approach our
planned completion of this work and the DSMB review scheduled for
July. The conclusion of the interim verification and analysis of
data will bring us one step closer to the completion of this study
and ultimately to making Neutrolin available in the U.S. to prevent
costly and potentially deadly catheter-related bloodstream
infections. The team continues to identify new potential CRBSI
cases which occurred subsequent to the early December 2017
deadline. These cases are being prepared for submission to the
Clinical Adjudication Committee (CAC) on an ongoing
basis.”
Additionally, the Company is pleased to
announce the appointment of Paul Chew, M.D., as Consultant Advisor
Chief Medical Officer to CorMedix, replacing the previous CMO who
resigned last year. Gary Gelbfish, M.D. will focus on board-level
matters while also continuing to provide clinical advice related to
the interim analysis as requested. The Company is grateful to Dr.
Gelbfish for his expert assistance and significant contributions
during this critical period of preparing for the interim
analysis.
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On his appointment, Dr. Chew commented, “I am thrilled to be
joining Liz Masson and the CorMedix team as we near the LOCK-IT 100
interim analysis. Neutrolin has the
potential to significantly reduce catheter-related blood stream
infections, a major unmet medical need. I also look forward to
contributing to CorMedix research aimed broadly toward finding a
preventative solution to decrease the threat of infection in
patients with a central venous catheter as well as in other
treatment conditions.”
Dr. Chew is a board certified internist and cardiologist by
training and has held several executive positions at major
pharmaceutical companies during his distinguished
career bringing
faster cures and treatments to patients. He served as Senior Vice-President, Global Chief
Medical Officer, and U.S. R&D head at Sanofi as well as Vice
President, Medical Affairs, U.S. at Bristol-Myers Squibb. He has a
substantial history of working with the European Medicines Agency
(EMA) and the U.S. Food and Drug Administration (FDA) including
lead sponsor representation at FDA Advisory Committees and EMA
Scientific Advisory Groups. Dr. Chew has spent more than 20
years at the Johns Hopkins University and School of Medicine, where
he received his B.Sc. in Human Biology, received his M.D.,
completed his residency, and held various faculty
positions.
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, including the interim analysis for the ongoing Phase 3
clinical trial; 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 Contact:
Dan
Ferry
Managing
Director
LifeSci
Advisors
617-535-7746
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