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8-K - CURRENT REPORT - CorMedix Inc. | crmd_8k.htm |
Exhibit 99.1
CorMedix Inc. Provides Update on Neutrolin® Ongoing Phase 3
Clinical Trial
Following Favorable FDA Correspondence
Bedminster, NJ – August 2, 2017 – CorMedix Inc.
(NYSE MKT: CRMD), a biopharmaceutical company focused on developing
and commercializing therapeutic products for the prevention and
treatment of infectious and inflammatory disease, today provided an
update on the Phase 3 clinical program for Neutrolin®, the
Company’s lead product candidate in the U.S., following
recent favorable correspondence with the U.S. Food and Drug
Administration (FDA). Based on a review of the status of the
ongoing LOCK-IT-100 clinical study and a revised plan put forth by
CorMedix, the FDA agreed to key changes to the study. The Company
believes that the changes endorsed by the FDA will facilitate the
company’s ability to complete the on-going Phase 3 study as
previously announced by year-end 2018.
The
Company sought guidance from the FDA to address, in part, the
apparent overall lower rate of catheter-related blood stream
infection (CRBSI) events as announced in April 2017.
The
following changes have been made:
1.
Use of a Clinical Adjudication Committee
(CAC): The FDA agreed to the utilization of a Clinical
Adjudication Committee (CAC) to critically and independently assess
suspected CRBSIs.
2.
Single blood culture: The FDA agreed
that the CAC will critically and independently assess suspected
CRBSIs in a blinded fashion based on a single positive blood
culture and supporting documentation. The current protocol
definition requires two positive blood cultures. The FDA has agreed
that the cases adjudicated by the CAC to be CRBSI events and the
per protocol definition of CRBSI events will be included in the
primary analysis of the primary efficacy endpoint of the
LOCK-IT-100 study.
3.
Enhance capture of cases occurring outside of
dialysis centers: This key change was designed to facilitate
more complete capture of CRBSI events in the study, particularly
when patients present with CRBSI events outside of the dialysis
center setting (emergency rooms or urgent care
centers).
4.
Study design: CorMedix has revised the
design of the study to detect a treatment effect of 55% or greater
when comparing the Neutrolin® and
heparin control arms. The amended study assumptions including a
reduction in statistical power have resulted in a reduction in the
total number of CRBSI events required from 161 events to 56 events
to complete the study.
CorMedix
believes the above-mentioned changes will allow the identification
of more infections, enabling a single interim analysis, which is
anticipated to occur in the fourth quarter of 2017 based on 28
CRBSI events. Should the interim analysis show sufficient
efficacy it may be possible to conclude the study earlier than
projected.
Khoso
Baluch, CorMedix Chief Executive Officer stated, “We are very
pleased to have agreement from the FDA regarding proposed revisions
to our ongoing trial to assess the safety and efficacy of Neutrolin
in preventing catheter-related bloodstream infections in patients
receiving hemodialysis therapy as treatment for end-stage renal
disease. We expect these changes to have a positive impact on our
ability to more comprehensively capture CRBSI events in the study.
Further, based on our experience in the LOCK-IT-100 trial, we are
reassessing the structure of our second planned Phase 3 study to
seek possible efficiencies and improvements in its design and
execution. We anticipate this process will be completed within the
next several months and we will provide updates as we are
able.”
About CorMedix Inc.
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. Such infections cost the U.S. healthcare
system approximately $6 billion annually and contribute
significantly to increased morbidity and mortality. Neutrolin is
currently in a Phase 3 clinical trial in patients undergoing
chronic hemodialysis via a central venous catheter. The Company is
working on the design of a planned second Phase 3 clinical trial,
which, if approved, would be subject to sufficient resources.
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 upon U.S.
approval. It is already a CE Marked product in Europe and other
territories. 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 possible inability to capture sufficient CRBSI
events in the ongoing Phase 3 clinical trial for
Neutrolin® even with the
reported changes to that trial; 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 planned or
future research, including 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.
For Investors & Media:
Tiberend Strategic Advisors, Inc.
Joshua
Drumm, Ph.D.: jdrumm@tiberend.com; (212) 375-2664
Janine
McCargo: jmccargo@tiberend.com; (646) 604-5150