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Exhibit 99.1
CorMedix Inc. Provides Comprehensive Pipeline Update
During Research and Development Day
Live Webcast Today, July 12, 2017, beginning at 8:30am
ET
Bedminster, NJ – July 12, 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 a
comprehensive overview and update on its ongoing pre-clinical and
clinical development programs, based on its taurolidine technology
platform. The “R&D Day” event will be webcast live
and archived on CorMedix’s website. To access the
webcast, visit the Events page at www.cormedix.com/media-publications/events/.
Keynote
speakers include Prabir Roy-Chaudhury, MD, Ph.D., Co-Principal
Investigator of the Neutrolin® Phase 3 LOCK-IT
100 clinical trial, Director of the Division of Nephrology and the
Arizona Kidney and Vascular Center at University of Arizona, and
Co-chair of the American Society for Nephrology’s Kidney
Health Initiative; Allison O’Neill, M.D., Assistant Professor
of Pediatrics at Harvard Medical School and Research Fellow at the
Dana-Farber Cancer Institute; Z. Paul Lorenc, M.D., F.A.C.S.,
World-renowned, board-certified Aesthetic Plastic Surgeon; and
Gregory Schultz, Ph.D., Director of the Institute for Wound
Research and Professor of Obstetrics and Gynecology at the
University of Florida.
CorMedix
has advanced several preclinical R&D programs, building upon
the key characteristics of taurolidine. These include potent
anti-microbial activity without resistance, anti-inflammatory
properties mediated by a reduction in certain cytokines including
IL-1, IL-6 and TNF, as well as selective pro-apoptotic and
cytotoxic activity against cancer cells. Taurolidine is also known
to penetrate biofilms and retain its activity against highly
drug-resistant bacteria and fungi, making it a potentially valuable
molecule for addressing the unmet need for new anti-microbial
products.
The
R&D Day event focuses on three key areas of CorMedix’s
taurolidine-based pipeline:
●
Development of
medical devices that incorporate taurolidine
●
Development of
taurolidine-based therapy for cancer
●
Continued
development of Neutrolin® for the
prevention of bloodstream infections
Development of Medical Devices that Incorporate
Taurolidine
CorMedix
has focused its R&D efforts to three initial medical device
areas where taurolidine incorporation may add value and potentially
improve patient outcomes. These include:
●
Development of anti-microbial suture
materials to prevent surgical site infections
(SSIs)
●
Development of antimicrobial
hydrogels to help prevent infections in burns and other wounds as well as treat
infections in those sites. The hydrogels may also be effective as
treatments for diabetic foot ulcers.
●
Development of non-woven antimicrobial
meshes to prevent infection and graft failure following
hernia repair and reconstructive surgery
The
2018 U.S. market is projected to be $1.7 billion for sutures, and
$1.0 billion each for hydrogels and non-woven meshes.
Development of Anti-Microbial Suture materials
CorMedix has been
successful in integrating multiple concentrations of taurolidine
(2%-10%) into monofilament suture materials, where the taurolidine
is dispersed throughout the matrix of the fibers (one prepared with
a homopolymer of epsilon-caprolactone and another fiber composed of
rho-dioxanone). Taurolidine could also be loaded onto the surface
of multifilament suture materials by integrating the drug into the
coating layer.
The
taurolidine-incorporated sutures were tested against clinically
significant bacterial species, including methicillin-resistant
Staphylococcus aureus
(MRSA), Staphylococcus
epidermidis, and Pseudomonas aeruginosa using two different
in vitro assays.
Effectiveness of the materials at eradicating these potentially
deadly microbes was confirmed using zone of inhibition (ZOI), where
bacterial growth was completely inhibited in the vicinity of the
taurolidine-loaded fibers; and by direct bacteria killing assays
that showed ~10 log (>99.9%) reduction in bacteria following
incubation with 6% taurolidine sutures.
CorMedix is in the
process of testing large-scale manufacturing of polydioxanone
sutures containing 7% taurolidine that mimics the processes in use
today. It involves creating drug-loaded polymer pellets that can be
extruded in a line that enables annealing and drawing similar to
the current commercial manufacturing of sutures. Zone of inhibition
studies recently confirmed that the taurolidine sutures retain
their antimicrobial activity when manufactured by this scalable
process.
Development of Anti-Microbial Non-Woven Meshes
Several
non-woven mesh candidates were prepared by electrospinning using a
variety of commercially available resorbable polymer constructs and
loaded with taurolidine at strengths ranging from 21-59% by weight.
The meshes were submerged in suspended cultures of P. aeruginosa and MRSA.
Taurolidine-incorporated meshes demonstrated complete killing of
these deadly bacteria at all strengths tested in less than four
hours of exposure.
Development of Anti-Microbial Hydrogels
Hyaluronic acid
(HA) hydrogels containing taurolidine demonstrated complete killing
of suspended cultures of P.
aeruginosa and MRSA at all concentrations of Taurolidine
tested (1.5%-6%). Furthermore, taurolidine hydrogels were effective
at penetrating mature biofilms of P. aeruginosa on the surface of pig
skin explants. High molecular weight HA + 3% taurolidine and
myristic acid (penetration enhancer) also showed complete killing
of the biofilm bacteria.
CorMedix
is currently conducting proof-of-concept studies in animal models
for each of its medical device candidates, and these studies will
continue during the second half of 2017.
CorMedix’s
regulatory strategy for its taurolidine-incorporated medical
devices is to utilize the 510(k) pathway, which uses predicate
medical devices which were approved previously for similar
indications, to potentially accelerate the timing and reduce the
amount of data and testing required for clearance by the U.S. Food
and Drug Administration (FDA). To utilize this pathway CorMedix
must identify predicate device(s) and demonstrate that its
candidate is substantially equivalent to the predicate device.
CorMedix has identified such potential predicate devices for each
of its candidates and plans to pursue this pathway as efficiently
as possible. In parallel, CorMedix intends to seek CE Marking for
its taurolidine-based medical devices for commercialization in
European Countries and other territories.
Development of Taurolidine-Based Therapy for Cancer
CorMedix
is collaborating with the Pediatric Oncology Experimental
Therapeutics Investigators' Consortium (POETIC) on preclinical
development of taurolidine-based therapies for cancer. To date,
initial candidate therapies have been developed and formulated for
delivery to tumors, including potential combination therapies
involving taurolidine plus another chemotherapy. The anti-cancer
activity of these candidates was evaluated successfully in various
cancer cell lines and animal studies are being planned. The goal of
these early studies is to establish feasibility and
proof-of-concept, as well as determine the optimal cancer
indication(s) to pursue and with which therapeutic regimen.
Currently, CorMedix and POETIC expect to utilize nano-technologies
to deliver taurolidine, either alone or in a drug combination, to
enable a slow, sustained release of the drug within tumors.
Multiple nanoparticle platforms are being evaluated.
Nanoparticle
delivery of taurolidine monotherapy markedly enhanced its ability
to kill neuroblastoma cells in vitro compared to free taurolidine
(IC50 =
37.6 uM vs 99.7 uM, respectively). They were also effective at
killing other tumor types, including non-small cell lung cancer
(IC50 =
137.8 uM). Furthermore, co-administration of taurolidine
nanoparticles and nanoparticles containing the chemotherapy agent
vincristine demonstrated a synergistic effect against neuroblastoma
cell lines compared to the activity of either drug alone. This
potential synergy is supported by published scientific research
showing that taurolidine can enhance the activity of cytotoxic
drugs, including vincristine, against neuroblastoma cells
in vitro. Pediatric
neuroblastoma is a rare cancer and an Orphan Disease opportunity.
CorMedix and its collaborators are focused on advancing this
program through preclinical studies and determining a potential
clinical strategy once in
vivo proof-of-concept is achieved.
Development of Neutrolin® for preventing
catheter-related bloodstream infection (CRBSI)
Neutrolin®
is a taurolidine-based, non-antibiotic, antimicrobial solution
designed to prevent costly and dangerous CRBSIs and thrombosis by
acting in the catheter lumen between catheter usage. CorMedix is
developing Neutrolin® in a pivotal
Phase 3 clinical program in the United States for preventing CRBSIs
in patients with end stage renal disease (ESRD) undergoing
hemodialysis via a central venous catheter. The product has CE
Marking and is available in Europe and other territories through
marketing and distribution partners. Taurolidine, the active
antimicrobial in Neutrolin®, is effective
against a broad range of bacteria and fungi, including
antibiotic-resistant strains, with no reported resistance in a
clinical setting.
An
important contributor to antibiotic resistance is the ability of
certain microorganisms to form biofilms. Biofilms play an important
role in the tenacity and pathology of a number of infectious
diseases, because within the biofilm, microorganisms tend to be
less metabolically active and highly resistant to antibiotics.
Taurolidine is not an antibiotic and its ability to penetrate
mature biofilms of clinically relevant bacteria has been
demonstrated successfully. Biofilms are also present on a very high
percentage of medical devices, including central venous catheters.
The taurolidine in Neutrolin® may prevent
biofilm from forming on the catheter lumen in between uses, making
it an effective means of maintaining proper bloodflow and catheter
patency.
Infections
are now on par with cardiovascular complications as a primary
reason for hospitalization and mortality among ESRD patients
receiving hemodialysis, and major health organizations are focused
on reducing or eliminating CRBSI. The American Society for
Nephrology recently partnered with the U.S. Centers for Disease
Control and Prevention (CDC) to develop the Nephrologists
Transforming Dialysis Safety (NTDS) project to promote infection
prevention in outpatient dialysis facilities. The use of innovative
products like Neutrolin®, which aligns
with current clinical and outpatient workflows as a catheter lock
solution, could become an important part of this effort to minimize
CRBSI and improve outcomes for patients.
Multidrug-resistant
Candida auris is an
emerging pathogenic yeast species causing serious illness in
humans, which the CDC has cited as a “serious global health
threat.” C. auris is
associated with life-threatening bloodstream and wound infections,
causing recent hospital outbreaks globally with high
mortality. It is resistant to all standard antifungals and is
able to form biofilms that enhance its pathogenicity and
persistence in the hospital setting. Patients with central venous
catheters are among those at highest risk of C. auris infection, which can lead to
potentially deadly CRBSIs.
CorMedix
announced the results of a special culture sensitivity test of
taurolidine against clinical isolates of C. auris, which showed 100% inhibition
of the yeast at the concentration of taurolidine currently
contained in Neutrolin®. As such,
Neutrolin may prevent C.
auris infections in one of the highest risk patient
populations. Furthermore, incorporation of taurolidine into
sutures, meshes, and hydrogels may help prevent C. auris infections in surgical wounds,
burns and diabetic foot ulcers. The sensitivity testing was
performed by premier microbiology and antimicrobial surveillance
laboratory JMI Laboratories. CorMedix looks forward to working with
global regulatory agencies to leverage the benefits of taurolidine
to possibly help prevent resistant microbial
infections.
Khoso
Baluch, President and CEO of CorMedix, stated, “We are
pleased to provide this overview of our R&D pipeline, which
represents multiple opportunities to generate significant long-term
value for our shareholders. Our focused efforts in the medical
device space and in oncology have demonstrated early successes that
we find very encouraging as we advance these programs in
proof-of-concept studies, which are currently in progress in
animals. Leveraging the unique properties of taurolidine in these
areas is a significant part of our overall growth strategy, as we
continue to execute on the U.S. clinical development and European
commercialization of Neutrolin®. We thank our
shareholders and our strategic collaborators for their continued
support.”
Webcast Information and Q&A
The
event will be webcast live and archived on CorMedix’s
website. To access the webcast, visit the Events page at
www.cormedix.com/media-publications/events/.
The
R&D Day will include several Q&A sessions. To submit a
question during the event, please email Cormedix@tiberend.com.
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 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 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: preclinical results are not indicative of success in
clinical trials and might not be replicated in any subsequent
studies or 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; 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;
obtaining additional financing to support CorMedix’s research
and development and clinical activities and operations; 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