Full Press Release Details
CorMedix Inc. Reports Update on Neutrolin Phase
LOCK-IT 100 Clinical Trial
Bedminster, NJ April 20, 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 announced
an update in its ongoing U.S. Phase 3 LOCK-IT 100
clinical trial of its lead product candidate Neutrolin , a novel,
non-antibiotic antimicrobial solution designed to prevent costly
and dangerous bloodstream infections associated with the use of
central venous catheters.
Company has to date enrolled 368 patients in the LOCK-IT 100
clinical trial and recently completed a safety review by an
independent Data and Safety Monitoring Board (DSMB). The DSMB
unanimously concluded that it is safe to continue the trial as
designed based on its evaluation of data from the first 279
patients randomized on trial.
currently in discussions with the FDA regarding possible
prospective changes to the protocol for this event-driven clinical
trial, in part to account for an apparent overall lower rate of
catheter-related blood stream infection (CRBSI) events. In
addition, the FDA has accepted the Company's proposal to
include one or more interim efficacy analyses of the trial data
while LOCK-IT 100 is ongoing. Pending attainment of the requisite
number of CRBSI events, the first such interim analysis could occur
as early as the fourth quarter of 2017, by which time the Company
anticipates that trial enrollment will have exceeded its originally
planned target of 632 patients. CorMedix is continuing to activate
clinical trial sites and to enroll additional patients to
facilitate the occurrence of the first interim analysis within this
timeframe. While the final details surrounding some aspects of the
clinical trial protocol remain subject to ongoing discussions with
the FDA, the Company currently anticipates that enrollment may
continue into the second quarter of 2018 in order to obtain the
final planned number of requisite CRBSI events, with topline
results expected to be available around year-end
are in close communication with the FDA regarding the LOCK-IT 100
trial, stated Judith Abrams, M.D., FRCPC, Chief Medical
Officer of CorMedix. We are pleased that the FDA has
accepted the inclusion of one or more interim efficacy analyses in
our clinical trial, which should allow us to obtain our first look
in the U.S. at Neutrolin's potential ability to reduce
catheter-related blood stream infections in patients with end-stage
renal disease receiving hemodialysis through a central venous
catheter. We intend to provide further information regarding the
proposed protocol amendments when we gain clarity from our
discussions with the FDA.
remain committed to bringing this important product candidate to
patients in the United States, as we endeavor to maximize the
opportunity for our shareholders, said Khoso Baluch,
President and CEO of CorMedix. We're grateful for the
continued discussion with the FDA, and we hope to be in a position
to complete the first interim efficacy analysis later this year.
The goal of healthcare organizations worldwide is to eliminate
costly and potentially deadly catheter-related bloodstream
infections altogether. Neutrolin was designed with this goal in
mind, and we believe that it can become an important product in
this space upon potential approval.
CorMedix Inc. is a biopharmaceutical company focused on developing
and commercializing therapeutic products for the prevention and
treatment of infectious and inflammatory disease. 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
planning to conduct its second Phase 3 clinical trial in patients
with cancer receiving IV parenteral nutrition, chemotherapy and
hydration via a chronic central venous catheter, subject to
sufficient resources. If successful, the two pivotal studies may be
submitted to the FDA for potential approval for both patient
populations. 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
for up to 10 years of 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
press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including with respect to attainment of sufficient CRBSI events to
allow the interim analyses of LOCK-IT 100 data, the timing, number
and sufficiency of patient enrollments, the timing of topline
results and the potential for changes to the clinical trial based
on discussions with the FDA, 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 timing and results of the planned
interim efficacy analyses of the LOCK-IT 100 trial and the impact
of those results on that trial; an inability to gain alignment with
the FDA on proposed protocol changes to the LOCK-IT 100 trial;
later developments with the FDA that may be inconsistent with the
FDA's acceptance of interim analyses of the LOCK-IT 100