PolarityTE Provides Update on U.S. FDA Investigational New Drug Application for SkinTE®
August 24 2021 - 7:00AM
Business Wire
PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company
developing regenerative tissue products and biomaterials, today
provided an update regarding correspondence from the U.S. Food and
Drug Administration (FDA) related to its Investigational New Drug
Application (IND) for SkinTE® with a proposed indication for
chronic cutaneous ulcers, which was filed on July 23, 2021. The FDA
provided feedback that certain Chemistry, Manufacturing, and
Control (CMC) items need to be addressed prior to proceeding with a
pivotal study. As a result, the study proposed in the IND has been
placed on clinical hold. In accordance with standard practice and
regulations, the FDA has advised that it will issue a clinical hold
letter providing details on the basis for the hold to the Company
by September 21, 2021.
PolarityTE previously disclosed that there was the potential for
a wide range of outcomes with respect to its SkinTE IND submission,
including but not limited to a clinical hold, and the Company is
already formulating a plan to address the issues identified by the
FDA. Based on FDA feedback the Company is confident that the
modifications made to its proposed clinical trial protocol in
Wagner Grade 2 diabetic foot ulcers will enable this pivotal study
to begin enrolling once the CMC issues are resolved.
David Seaburg, Chief Executive Officer, commented, “In our July
26, 2021, press release regarding the IND submission we described
the FDA’s well-established procedures for IND submissions and we
believe that the CMC issues FDA has identified are not necessarily
unusual for companies working diligently to transition their
products from 361 HCT/Ps to 351 HCT/Ps. We are actively working to
address the issues identified by the FDA and our team plans to
respond to the Agency’s feedback as expeditiously as possible, and
we are hopeful that we will be able to resolve any open items.
Chronic cutaneous ulcers represent a substantial unmet medical need
with significant economic burden, and we are grateful for FDA’s
engagement and eager to advance SkinTE through clinical studies and
the regulatory process towards an eventual BLA submission.”
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/20210824005288/en/
Investors: Rich Haerle VP, Investor Relations PolarityTE,
Inc. ir@PolarityTE.com (385) 315-0697
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