SALT
LAKE CITY, May 3, 2022 /PRNewswire/ -- PolarityTE,
Inc. (Nasdaq: PTE) today announced the enrollment of the first
subject in the Phase III pivotal study evaluating SkinTE in the
investigational use of treatment of Wagner grade 2 diabetic foot
ulcers (DFUs), entitled "Closure Obtained with Vascularized
Epithelial Regeneration for DFUs with SkinTE," or "COVER
DFUs."
COVER DFUs will enroll up to 100 subjects at up to 20 clinical
sites in the United States. Subjects will be randomized to
one of two treatment groups, receiving either SkinTE plus the
standard of care (SOC) or the SOC alone. The primary endpoint
is the incidence of DFUs closed at 24 weeks. Secondary
endpoints include percent area reduction (PAR) at 4, 8, 12, 16 and
24 weeks; improved quality of life, including social isolation,
depression, odor, improved function, ambulation, and return to
activities based on changes in wound quality of life; and new onset
infection of the DFU requiring treatment with topical and/or
systemic antibiotics.
COVER DFUs is the first pivotal study that PolarityTE will
conduct under its open IND for SkinTE with an indication for the
treatment of chronic cutaneous ulcers (CCUs). CCUs are wounds
that have failed to progress through the orderly and timely tissue
repair processes necessary to restore the normal function and
anatomy of skin. DFUs, pressure injuries (PI), and venous leg
ulcers (VLU) make up the vast majority of CCUs, and affect an
estimated 8 million patients annually, or ~2% of the United States (US) population. CCU
prevalence is expected to increase as the population ages and the
incidence of diabetes, cardiovascular disease, and obesity continue
to rise. Accordingly, CCUs represent an enormous market
opportunity at present, and PolarityTE expects that opportunity to
grow.
Richard Hague, Chief Executive
Officer, commented, "Enrolling our first subject in a pivotal study
under an FDA-accepted IND is a critical milestone for the company
and a testament to the determination and commitment of our entire
team. I would like to thank our employees who have worked so
hard to reach this point, and I cannot overstate the excitement
within our organization to see SkinTE return to the clinic.
We are especially proud to launch our first pivotal study in
Wagner Grade 2 DFUs, which often involve exposed critical
structures. Patients suffering from these challenging wounds
have very limited treatment options and we are hopeful that our
research in COVER DFUs can usher a new treatment to fulfill these
patients' substantial unmet medical needs. We want to thank
the subjects and medical providers who will participate in COVER
DFUs for supporting our efforts to bring meaningful change to this
patient community."
Nikolai Sopko, MD, PhD, Chief
Scientific Officer, commented, "The type of wounds that we are
targeting with our CCU indication often persist for years, and some
remain unhealed for decades. Due to their chronicity, CCUs increase
a patient's vulnerability to infection and have significant
morbidity and mortality risk, which is increased in larger wounds
or wounds that extend to a greater depth. For these patients, there
is the very real possibility of full or partial limb amputation
with associated disability. Eighty-five percent of non-traumatic
limb amputations are associated with CCU, with an estimated limb
amputation occurring every 30 seconds." Dr. Sopko continued,
"I would like to sincerely thank our clinical team for their
tireless efforts to bring us to this important milestone for
SkinTE, and we look forward to the work ahead."
Dr. Felix Sigal, DPM, is the site
investigator for the Los Angeles Foot & Ankle Clinic where the
first subject was enrolled in COVER DFUs. Dr. Sigal is
currently on staff at both the Hollywood Presbyterian Hospital and
the California Hospital Medical Center, where he focuses on wound
care, diabetic limb salvage, and pursues his interest in clinical
research to enable development of better treatment options for his
patients. Dr. Sigal is one of the most distinguished specialists in
the field and serves as a Principal Investigator on numerous
clinical research studies in the field of diabetic complications
and wound care.
Dr. Sigal commented, "Patients suffering from DFUs, and
especially those suffering from Wagner 2 DFUs, are in urgent need
of new and improved options to address their substantial and unmet
medical needs. Far too often, we see these patients progress
to the point of requiring amputation, and as providers we are
constantly seeking solutions to improve outcomes for our
patients. Following my experience with SkinTE in the last
successful randomized controlled trial evaluating SkinTE in Wagner
grade 1 DFUs, I am pleased to participate in the COVER DFUs study,
which is an important step in evaluating a potential solution for
these patients in dire need."
About PolarityTE®
PolarityTE, Inc., headquartered in Salt Lake City, Utah, is a biotechnology
company developing regenerative tissue products. PolarityTE's
first regenerative tissue product is SkinTE®. PolarityTE has
an open investigational new drug application (IND) for SkinTE® with
the U.S. Food and Drug Administration (FDA) and is now pursuing the
first of two pivotal studies on SkinTE® needed to support a
biologics license application (BLA) for a chronic cutaneous ulcer
indication. SkinTE® is available for investigational use
only. Learn more at www.PolarityTE.com.
Forward Looking
Statements
Certain statements contained in this release are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. They are generally
identified by words such as "believes," "may," "expects,"
"anticipates," "intend," "plan," "will," "would," "should" and
similar expressions. Readers should not place undue reliance on
such forward-looking statements, which are based upon the Company's
beliefs and assumptions as of the date of this release. The
Company's actual results could differ materially due to the impact
of the COVID-19 pandemic, future clinical studies, and FDA
regulatory matters, which cannot be predicted, and the risk factors
and other items described in more detail in the "Risk Factors"
section of the Company's Annual Reports and other filings with the
SEC (copies of which may be obtained at www.sec.gov). Subsequent
events and developments may cause these forward-looking statements
to change. The Company specifically disclaims any obligation or
intention to update or revise these forward-looking statements as a
result of changed events or circumstances that occur after the date
of this release, except as required by applicable law.
POLARITYTE, the POLARITYTE logo, SKINTE, WHERE SELF REGENERATES
SELF and WELCOME TO THE SHIFT are registered trademarks of
PolarityTE, Inc.
CONTACTS
Investors:
PolarityTE Investor Relations
ir@PolarityTE.com
(385) 831-5284
Media:
David Schull or
Ignacio Guerrero-Ros
David.schull@russopartnersllc.com
Ignacio.guerrero-ros@russopartnersllc.com
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SOURCE PolarityTE, Inc.