Full Press Release Details
CORMEDIX RECEIVES ENCOURAGING FDA FEEDBACK ON NEUTROLIN
Company Completes Phase 3 of Clinical Development
Heights, NJ July 9, 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 received feedback from the U.S. FDA regarding the
submitted statistical analyses of data and additional information
requested by the FDA for the primary and secondary efficacy
endpoints of the Company's LOCK-IT-100 clinical study.
LOCK-IT-100 examined the safety and effectiveness of the
investigational new drug Neutrolin as a catheter lock
solution compared to heparin for the prevention of catheter-related
bloodstream infection (CRBSI) in hemodialysis patients. Based on
the FDA's feedback, the Company believes it has completed
Phase 3 of clinical development for Neutrolin in hemodialysis
patients and does not need to conduct another clinical trial at
feedback, the FDA did not raise any additional questions regarding
the analyses provided and indicated that it would conduct a
thorough review of all of the clinical data when the clinical study
report is submitted for LOCK-IT-100. In FDA's response to the
Company's question on whether LOCK-IT-100 is adequate as a
single study to support a New Drug Application (NDA), the FDA
stated that while the data from LOCK-IT-100 and supporting
information may be sufficient, it cannot confirm that the data from
LOCK-IT-100 are adequate to support an indication for prevention of
CRBSI in hemodialysis patients until it has completed its review of
the NDA. The Company will continue discussions with the FDA
concerning the chemistry, manufacturing and controls (CMC) data
that will be needed to support Neutrolin's NDA. FDA's
feedback on the CMC data is an important regulatory requirement
prior to the Company requesting a pre-NDA meeting.
Baluch, President and CEO of CorMedix commented, We are
pleased with FDA's responses to our statistical analyses of
data and additional information provided for the primary and
secondary efficacy endpoints of the LOCK-IT-100 study. This
completes another important milestone for Neutrolin. We look
forward to continuing the dialogue with FDA on the CMC data needed
to support the filing of the NDA.
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:
Forward-Looking Statements
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, including the need for a second
Phase 3 trial; 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; risks related to obtaining FDA approval of the new
drug application for Neutrolin; 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