SkinTE® Met Primary and Secondary Endpoints in Final Analysis from Diabetic Foot Ulcer Trial
July 28 2021 - 8:00AM
Business Wire
Data Included in Investigational New Drug
Application Submitted on July 23, 2021
Company Announces Completion of Study
Evaluating SkinTE for the treatment of Venous Leg Ulcers
PolarityTE, Inc. (Nasdaq: PTE) today announced final data
from a multi-center randomized controlled trial evaluating
treatment of Diabetic Foot Ulcers (DFU) with its investigational
product SkinTE® plus standard of care (SOC) vs SOC alone
(NCT03881254). The trial met the primary endpoint of wound closure
at 12 weeks and secondary endpoint of Percent Area Reduction (PAR)
assessed at 4, 6, 8, 10, and 12 weeks. 100 participants were
evaluated across 13 sites with 50 participants receiving SkinTE
plus SOC and 50 receiving SOC alone. PolarityTE is pleased to
announce today the final analysis of the full data set, which
includes:
- Primary Endpoint: 70% (35/50) of participants receiving
SkinTE plus SOC had wound closure at 12 weeks versus 34% (17/50) of
participants receiving SOC alone (p=0.00032)
- Secondary Endpoint: Percent Area Reduction (PAR)
assessed at 4, 6, 8, 10, and 12 weeks was significantly greater for
the SkinTE plus SOC treatment group vs SOC alone (p=0.009)
- 90% (45/50) of SkinTE plus SOC treated participants received a
single application of SkinTE
- Treatment with SkinTE plus SOC increased the odds of wound
closure by 5.37 times versus SOC (p=0.001)
Mean (SD) values for PAR at weeks 4, 6, 8,
10, and 12 by treatment group
Week
SkinTE
SOC
4
74.0 (27.63)
22.0 (149.92)
6
82.9 (26.35)
21.2 (160.60)
8
80.7 (35.16)
26.8 (147.42)
10
79.7 (54.07)
45.6 (114.18)
12
84.3 (39.46)
50.5 (92.24)
- 148 Adverse Events (AEs) were allocated to 49 subjects. The
SkinTE plus SOC treatment group had 66 AEs allocated to 21 subjects
while the SOC treatment group had 82 AEs allocated to 28 subjects.
There were 26 Serious Adverse Events (SAEs), 12 in the SkinTE plus
SOC treatment group (7 subjects) and 14 in the SOC treatment group
(9 subjects).
- Wound size for the SkinTE plus SOC treatment group was 3.5 cm2
versus 3.2 cm2 for the SOC treatment group (p=0.46). A comparison
by treatment group for wound-related variables showed that
variables were well balanced between groups with the exception of
sharp debridement count, which was marginally statistically
significantly higher in the SOC group compared to the SkinTE group,
due to shorter wound closure times in the SkinTE group.
While this DFU study will not be considered to be a
registrational trial as part of a Biologic License Application
(BLA), the Company incorporated data from the trial as part of its
Investigational New Drug (IND) application to the FDA, which was
submitted on July 23, 2021.
Additionally, PolarityTE announced a randomized controlled trial
evaluating SkinTE versus SkinTE plus SOC in Venous Leg Ulcers
(VLUs) has been completed with a total of 29 enrolled participants.
Topline data from the VLU trial will be announced via press release
in the second half of 2021.
Nikolai Sopko, MD, PhD commented, “Every 1.2 seconds someone in
the U.S. develops a diabetic foot ulcer and the full results of
this study further solidify our belief that SkinTE has significant
potential to positively impact the lives of patients suffering from
debilitating wounds. We are incredibly grateful to all of the
subjects who participated in the study, our Principal Investigator,
Dr. David Armstrong, all of the investigators in the trial, and the
healthcare providers and clinical trial teams. Without their
willingness to see this trial through to completion, we would not
be in the position we are in today with data and real-world
experience that illustrates the potential of SkinTE.”
About PolarityTE®
PolarityTE is focused on transforming the lives of patients by
discovering, designing, and developing a range of regenerative
tissue products and biomaterials for the fields of medicine,
biomedical engineering and material sciences. Rather than
manufacturing with synthetic and foreign materials within
artificially engineered environments, PolarityTE manufactures
products from the patient's own tissue and uses the patient's own
body to support the regenerative process. From a small piece of
healthy autologous tissue, the company creates an easily
deployable, dynamic, and self-propagating product designed to
regenerate the target tissues. PolarityTE's innovative methods are
intended to promote and accelerate growth of the patient's tissues
to undergo a form of effective regenerative healing. PolarityTE’s
products, including SkinTE, are in the development stage, and are
not approved or available for clinical use. Learn more at
www.PolarityTE.com – Welcome to the Shift®.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210728005156/en/
Investors: Rich Haerle VP, Investor Relations PolarityTE,
Inc. ir@PolarityTE.com (385) 315-0697
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