STAINES-UPON-THAMES, United
Kingdom, June 15, 2020
/PRNewswire/ -- Mallinckrodt
plc (NYSE: MNK), a global biopharmaceutical company, today
announced it will present data from the pivotal Phase 3 clinical
trial (STRATA2016) of its investigational product
StrataGraft®, a regenerative skin tissue therapy in
development for the treatment of deep partial-thickness thermal
burns, as well as health economics and outcomes research (HEOR) and
other data on the treatment of burns as part of the virtual
American Burn Association (ABA) 52nd Annual Meeting. The
virtual meeting begins today and is accessible online for attendees
during the next 90 days. StrataGraft skin tissue is an
investigational product, and its safety and effectiveness have not
yet been established by the U.S. Food and Drug Administration
(FDA).
The preliminary analysis of data from the Phase 3 trial will be
presented by Dr. James H. Holmes,
IV, via a prerecorded video, and available for attendees as
part of the virtual meeting. The video presentation is part of the
Education Forum as one of the "Top Five Abstracts," after receiving
one of the top scores by blinded reviewers. The abstract from the
Phase 3 trial was previously published in the Journal of
Burn Care & Research.
"We are pleased to be sharing the results from our pivotal Phase
3 clinical trial of StrataGraft regenerative skin tissue, as well
as data that provides insights into the implications of
autografting during this year's virtual ABA Annual Meeting," said
Steven Romano, M.D., Executive
Vice President and Chief Scientific Officer at Mallinckrodt. "At Mallinckrodt, we are
committed to research in support of patients with severe burns. If
approved, StrataGraft skin tissue would be a potential new
treatment option for deep partial-thickness thermal burns to help
reduce or eliminate the need to harvest healthy skin tissue from an
uninjured site through autografting."
Phase 3 Clinical Trial Data
Title:
|
Preliminary Analysis
of a Phase 3 Open-Label, Controlled, Randomized Trial Evaluating
the Efficacy and Safety of a Bioengineered Regenerative Skin
Construct in Patients with Deep Partial-thickness Thermal
Burns
|
Virtual
Location:
|
Part of the Education
Forum
|
Session:
|
Top 5
Abstracts
|
Presentation
#:
|
T5
|
Other Poster Presentations
Title:
|
Skin Graft Donor-Site
Morbidity – A Systematic Literature Review
|
Virtual
Location:
|
Exhibit
Hall
|
Session:
|
Poster Session –
R-123 Clinical Sciences: Wounds and Scars 1
|
Poster #:
|
522
|
|
|
Title:
|
Healthcare Resource
Utilization and Costs of Care Among Pediatric Patients with Thermal
Burns Undergoing Inpatient Autografting in a US Managed Care
Population
|
Virtual
Location:
|
Exhibit
Hall
|
Session:
|
Poster Session –
R-125 Public Health/Epidemiology 1
|
Poster #:
|
540
|
|
|
Title:
|
Establishing
Thresholds for Clinically Significant Donor Skin Reduction –
Initial Findings from a Physician Delphi Panel
|
Virtual
Location:
|
Exhibit
Hall
|
Session:
|
Poster Session –
R-224 Clinical Sciences: Wounds and Scars 4
|
Poster #:
|
730
|
About StrataGraft
StrataGraft regenerative skin
tissue is an investigational treatment being developed to reduce
autograft in patients with severe thermal burns. An engineered,
bilayer tissue, StrataGraft skin tissue is designed to mimic
natural human skin with both inner dermis-like and outer
epidermis-like layers. StrataGraft skin tissue can be sutured,
stapled or secured with an adhesive. StrataGraft skin tissue is
cryopreserved in order to deliver viable cells upon
application.
Mallinckrodt is currently conducting
a StrataGraft skin tissue continued access clinical trial
(StrataCAT, NCT04123548) under an Expanded Access Program (EAP).
The trial sites involved in the pivotal Phase 3 trial (STRATA2016,
NCT03005106) have the opportunity to participate in this
multicenter, open-label study. The company is planning to evaluate
StrataGraft skin tissue for the treatment of adults with
full-thickness burns (also referred to as third-degree burns).
Additionally, Mallinckrodt plans to
conduct a study evaluating StrataGraft skin tissue in treatment of
pediatric populations.
StrataGraft skin tissue is an investigational product, and
its safety and effectiveness have not yet been established by the
FDA.
Mallinckrodt announced the
completion of the rolling submission of a Biologics License
Application to the FDA for StrataGraft skin tissue for the
treatment of adult patients with deep partial-thickness thermal
burns on June 9, 2020. The FDA has
granted StrataGraft skin tissue orphan drug status, and it was
among the first products designated by the Agency as a Regenerative
Medicine Advanced Therapy (RMAT) under the provisions of the 21st
Century Cures Act.
Funding and technical support for the continued development of
StrataGraft skin tissue, including the pivotal Phase 3 clinical
study (STRATA2016) and the Biological Licensing Application process
for StrataGraft skin tissue in the United
States, is being provided by the Biomedical Advanced
Research and Development Authority (BARDA), under the Assistant
Secretary for Preparedness and Response, within the U.S. Department
of Health and Human Services, under Project BioShield Contract No.
HHSO100201500027C. These efforts are part of BARDA's strategy to
build emergency preparedness in response to mass casualty events
involving trauma and thermal burns by developing novel medical
countermeasures for adult and at-risk populations. In the case of a
mass casualty thermal burn event, the Government Accountability
Office estimates that more than 10,000 patients might require
thermal burn care.[1] The limited number of specialized burn
centers and related medical infrastructure in the United States creates a public health need
for therapies that could be deployed quickly for use in these and
other care sites.
About Deep Partial-Thickness Thermal Burns
Deep
partial-thickness thermal burns are complex skin injuries in which
the damage extends through the entire epidermis (outermost layer of
skin) and into the lower part of the dermis (innermost layer of
skin).
Autograft is considered to be a standard of care by many for
deep partial-thickness thermal burns. It involves the surgical
harvesting of healthy skin tissue from an uninjured site on the
patient and transplanting the skin graft to the injury. While this
process can be effective in providing closure of the original
wound, it has significant limitations related to the donor site
wounds created during surgical removal of the skin tissue for
grafting. Donor site wounds are painful and can create risks of
additional scarring and infection. In addition, the amount of
healthy skin available for harvesting is frequently limited in
those patients with large burns, necessitating sequential
re-harvesting of available donor sites. As a result, there is a
need for alternatives to donor site harvesting for the treatment of
severe burns.
About Mallinckrodt
Mallinckrodt is a global business
consisting of multiple wholly owned subsidiaries that develop,
manufacture, market and distribute specialty pharmaceutical
products and therapies. The company's Specialty Brands reportable
segment's areas of focus include autoimmune and rare diseases in
specialty areas like neurology, rheumatology, nephrology,
pulmonology and ophthalmology; immunotherapy and neonatal
respiratory critical care therapies; analgesics and
gastrointestinal products. Its Specialty Generics reportable
segment includes specialty generic drugs and active pharmaceutical
ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt uses its website as a
channel of distribution of important company information, such as
press releases, investor presentations and other financial
information. It also uses its website to expedite public access to
time-critical information regarding the company in advance of or in
lieu of distributing a press release or a filing with the U.S.
Securities and Exchange Commission (SEC) disclosing the same
information. Therefore, investors should look to the Investor
Relations page of the website for important and time-critical
information. Visitors to the website can also register to receive
automatic e-mail and other notifications alerting them when new
information is made available on the Investor Relations page of the
website.
Cautionary Statements Related to Forward-Looking
Statements
This release includes forward-looking statements
concerning StrataGraft regenerative skin tissue, including
expectations with regard to related regulatory filings, its
potential impact on patients, and anticipated benefits associated
with its use. The statements are based on assumptions about many
important factors, including the following, which could cause
actual results to differ materially from those in the
forward-looking statements: satisfaction of regulatory and other
requirements; actions of regulatory bodies and other governmental
authorities; changes in laws and regulations; issues with product
quality, manufacturing or supply, or patient safety issues; and
other risks identified and described in more detail in the "Risk
Factors" section of Mallinckrodt's most
recent Annual Report on Form 10-K and other filings with the SEC,
all of which are available on its website. The forward-looking
statements made herein speak only as of the date hereof and
Mallinckrodt does not assume any
obligation to update or revise any forward-looking statement,
whether as a result of new information, future events and
developments or otherwise, except as required by law.
CONTACTS
Media Relations
Sheryl
Seapy
W2O
213-262-9390
sseapy@w2ogroup.com
Investor Relations
Daniel J.
Speciale, CPA
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@mnk.com
Mallinckrodt, the "M" brand mark and
the Mallinckrodt Pharmaceuticals logo are trademarks of a
Mallinckrodt company. Other brands are
trademarks of a Mallinckrodt company or
their respective owners.
©2020 Mallinckrodt. US-2001050
06/20.
1 https://www.gao.gov/assets/590/588738.pdf.
Accessed February 12, 2020.
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SOURCE Mallinckrodt plc