STAINES-UPON-THAMES, United
Kingdom, Aug. 13, 2019
/PRNewswire/ -- Mallinckrodt
plc (NYSE: MNK), a leading global biopharmaceutical company,
today announced publication of results of its Phase 1b clinical trial of StrataGraft®, an
investigational regenerative tissue, in Burns, the journal
of the International Society for Burn Injuries (ISBI). Study data
showed that treatment with a single application of StrataGraft
tissue resulted in wound closure by three months in 27 of 29 study
participants. None of these 27 study participants required the
harvest of donor skin (autograft) by 28 days after
application. Additionally, the observed characteristics of the
wounds treated with StrataGraft were comparable to those treated
with autograft at 12 months after treatment. The safety and
effectiveness of StrataGraft have not yet been established by the
U.S. Food and Drug Administration (FDA).
"In the last two to three decades, survival among burn patients
has increased, but there have been few advances in the treatment of
severe burn wounds. New approaches are needed to help minimize the
challenges associated with autografting, the current standard of
care," said Dr. James H. Holmes
IV, Director of Wake Forest Baptist Medical Center's Burn
Center. "The results of the Phase 1b study of StrataGraft are encouraging and
suggest that this investigational regenerative tissue could
potentially reduce or eliminate the need for autografting, which
may minimize pain and other risks."
Autograft is considered to be a standard of care by many for
deep partial-thickness thermal burns, complex skin injuries in
which the burn extends into the lower dermis (skin below the
surface of the outer layer of skin), as well as the entire
epidermis (outer layer of skin). As autograft involves the surgical
harvesting of healthy skin from an uninjured site on the patient
and transplanting the skin graft to the injury, patients have two
wounds requiring care. Not only do patients experience increased
pain, but both the burn injury site and the donor site are at
increased risk of infection, scarring and impaired skin
function.
"Based on the positive efficacy and safety results of the Phase
1b study, we advanced the clinical
development of StrataGraft tissue and recently completed enrollment
in a pivotal Phase 3 trial evaluating StrataGraft in adults with
deep partial-thickness thermal burns," said Steven Romano, M.D., Executive Vice President
and Chief Scientific Officer at Mallinckrodt. "We are appreciative of the
patients who have participated in the clinical development program
for StrataGraft. If data from the pivotal Phase 3 trial are
supportive, we anticipate submitting a Biologics License
Application to the FDA in 2020. We believe that StrataGraft, if
approved, has the potential to revolutionize the treatment of
patients with deep partial-thickness thermal burns, and we are
committed to bringing it to patients in need as quickly as
possible."
Top-line data from the StrataGraft Phase 3 pivotal trial are
expected to be released in the next few months.
Design and Results of StrataGraft Regenerative Tissue Phase
1b Study
The prospective,
randomized, controlled, open-label, multicenter, dose-escalation
Phase 1b study (STRATA2011) assessed
the safety, tolerability and efficacy of a single application of
StrataGraft tissue compared with autograft for the treatment of
deep partial-thickness thermal burns. A total of 30 study
participants ages 18 to 65 years with deep partial-thickness
thermal burns of 3-49% total body surface area (TBSA) were treated
with StrataGraft in three dose-escalation cohorts of 10 patients
each:
- Cohort 1: ≤220 cm2 refrigerated StrataGraft
tissue
- Cohort 2: ≤440 cm2 refrigerated StrataGraft
tissue
- Cohort 3: ≤440 cm2 of cryopreserved StrataGraft
tissue
Two areas of deep partial-thickness burns on the upper or lower
extremities or torso of each study participant were randomly
assigned 1:1 to receive StrataGraft or autograft control treatment.
The coprimary endpoints of the study were the percent area of the
StrataGraft treatment site requiring autografting by Day 28, and
wound closure (defined as ≥95% re-epithelialization with absence of
drainage) of the treatment sites at three months
post-treatment. Secondary efficacy endpoints included the
proportion of treatment site wounds completely closed, percent
wound closure, cosmesis (physical appearance) of treatment and
donor sites, and donor site pain.
Key primary and secondary clinical endpoint findings included
the following:
- Study participants experienced a reduction in the percent area
autografted at the StrataGraft tissue treatment site relative to
the autograft treatment site. By Day 28, no StrataGraft-treated
sites required autografting.
- By three months post-treatment, 27 of 29 study participants
(93%) in the intent-to-treat population achieved wound closure at
the burn site treated with StrataGraft.
- Overall, the proportion of treatment site wounds that achieved
closure was not statistically different between StrataGraft and
autograft treatment (p=0.491).
- Evaluation of scarring using Patient and Observer Scar
Assessment Scale (POSAS) scores showed no significant differences
between outcomes for StrataGraft and autograft treatment sites at
any timepoint as assessed by clinical observers, or at 12 months
after treatment as assessed by study participants.
- Wounds treated with StrataGraft did not require harvesting at
prospective donor sites, resulting in less reported pain.
The Phase 1b study results showed
that safety observations for StrataGraft tissue were comparable to
those for autograft. Pruritus (itching) was the most commonly
reported treatment-emergent adverse event (TEAE), occurring in five
of 30 study participants (17%); two of the five were possibly
related to study treatment. All study treatment-related TEAEs were
mild or moderate in severity, and all resolved by the end of the
study. Local infection was not observed at any of the StrataGraft
treatment sites.
For more information about the design of the Phase 1b clinical trial, visit
www.clinicaltrials.gov (NCT01437852).
About StrataGraft Regenerative Tissue
StrataGraft is
an investigational regenerative tissue in development to reduce or
eliminate autograft in patients with severe thermal burns. An
engineered, bilayer tissue, StrataGraft is designed to mimic
natural human skin with both inner dermis-like and outer
epidermis-like layers. StrataGraft can be sutured, stapled or
secured with an adhesive. StrataGraft tissue is cryopreserved in
order to deliver viable cells upon application.
Mallinckrodt is currently evaluating
StrataGraft in an ongoing pivotal Phase 3 clinical trial, which is
assessing the efficacy and safety of StrataGraft in the promotion
of autologous skin regeneration of complex skin defects due deep
partial-thickness burns. Enrollment in the Phase 3 trial is
complete. The company is also evaluating StrataGraft in an ongoing
Phase 2 trial for the treatment of adults with full-thickness burns
(also referred to as third-degree burns). Mallinckrodt also plans to study StrataGraft in
pediatric populations.
StrataGraft regenerative tissue is an investigational product.
The safety and effectiveness of StrataGraft have not yet been
established by the FDA.
The FDA has granted StrataGraft 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.
The Phase 1b trial was funded by a
grant from the Armed Forces Institute of Regenerative Medicine I
(contract W81XWH-08-2-0032) to Wake Forest
University Health Sciences with a subcontract (WFUHS 40269).
Funding and technical support for the continued development of
StrataGraft regenerative tissue 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 pediatric 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 U.S. creates a public health need for
therapies that could be deployed quickly for use in these and other
care sites.
About Deep Partial-Thickness Burns
Deep
partial-thickness burns are complex skin injuries in which the burn
extends down into the lower dermis (the skin below the surface of
the outer layer of skin) as well as the entire epidermis (outer
layer of skin).
Autograft is considered to be a standard of care by many for
deep partial-thickness 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 extremely painful and can create risks of additional
scarring and infection. In addition, the amount of healthy skin
available for harvesting is frequently limited in large burns,
necessitating sequential re-harvesting of available donor sites. As
a result, there is an urgent 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
with regard to StrataGraft regenerative tissue, including
expectations with regard to clinical data and regulatory filings,
future research, 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: clinical trial results;
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
Carin
Ganz (trade and general media)
W2O for Mallinckrodt
212-301-7217
cganz@w2ogroup.com
Daniel Yunger (financial
media)
Kekst CNC for Mallinckrodt
212-521-4879
mallinckrodt@kekstcnc.com
Investor Relations
Daniel J.
Speciale, CPA
Vice President, Investor Relations and IRO, Mallinckrodt
314-654-3638
daniel.speciale@mnk.com
Mallinckrodt, the "M" brand mark and
the Mallinckrodt logo are trademarks of
a Mallinckrodt company. Other brands
are trademarks of a Mallinckrodt
company or their respective owners. © 2019 Mallinckrodt. US-1901096
08/19
¹ https://www.gao.gov/assets/590/588738.pdf.
Accessed April 23, 2019.
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SOURCE Mallinckrodt plc