Mallinckrodt Enrolls First Patient in Phase 3 Trial of StrataGraft® Regenerative Skin Tissue

STAINES-UPON-THAMES, United Kingdom, June 7, 2017 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today confirmed enrollment of the first patient in the company's Phase 3 study assessing the efficacy and safety of StrataGraft regenerative skin tissue in the promotion of autologous skin regeneration of complex skin defects due to thermal burns that contain intact dermal elements.

"There have been few advancements in burn surgery in the last two to three decades," said lead investigator James H. Holmes, IV, M.D., Director of the Burn Center at Wake Forest Baptist Medical Center and Associate Professor of Surgery, Winston-Salem, NC. "We are very excited to further study StrataGraft to learn how it could meet the needs of patients."

About the Clinical Trial
The Phase 3 clinical study is entitled "A Phase 3 Open-label, Controlled, Randomized, Multicenter Study Evaluating the Efficacy and Safety of StrataGraft Skin Tissue in Promoting Autologous Skin Tissue Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements and for Which Excision and Autografts Are Clinically Indicated." The study will include patients with 3-49% total body surface area complex skin defects due to thermal burns with intact dermal elements for which excision and autografting are clinically indicated. Autograft can be defined as surgically harvesting the patient's own uninjured skin for use as a graft on the injured site.

Outcome measures at 3 months will include 1) the percentage area of the StrataGraft treatment site that requires a subsequent autograft as compared to the control autograft treatment site, and 2) the proportion of subjects that have achieved durable wound closure of the StrataGraft treatment site without autograft placement.

"Mallinckrodt is committed to providing treatment options for patients with unmet medical needs, and nowhere is that need more marked than in the burn unit," said Lynn Allen-Hoffmann, Senior Vice President of Regenerative Medicine at Mallinckrodt. "We are pleased to enroll the first patient in our Phase 3 clinical trial."

Allen-Hoffmann continued, "We are honored to be working with the United States Biomedical Advanced Research and Development Authority (BARDA) which has been instrumental in the late-stage development of StrataGraft. This Phase 3 clinical trial is part of a larger, five-year contract, and BARDA's support has built on the critical, early-stage backing received from the National Institutes of Health and the Department of Defense. These organizations have long recognized the critical medical need for innovative products to address severe burns."

BARDA is supporting StrataGraft development as part of its effort to accelerate emergency preparedness in response to mass casualty events involving trauma and thermal burns. The Government Accountability Office estimates that a mass casualty thermal burn event could result in more than 10,000 patients in need of burn care, highlighting the critical need for improved definitive burn treatments. Together, BARDA's Advanced Research and Development Program and Project BioShield have provided more than $77.8 million to advance StrataGraft tissue to Phase 3 studies.

Find more information about the trial here on the ClinicalTrials.gov website. This project has been funded in whole or in part with federal funds from the Office of the Assistant Secretary for Preparedness and Response, BARDA, under Contracts No. HHSO100201300017c and HHSO100201500027C.

About Serious Thermal Burns Containing Intact Dermal Elements
Deep partial-thickness burns are complex skin injuries where the entire epidermis and more than two thirds of the dermis is destroyed. The treatment for severe complex skin wounds with substantial loss of the dermis such as deep partial-thickness burns is the surgical harvesting of a sheet of healthy skin from an uninjured site on the patient and transplantation of this autologous skin graft to the injury once the wound is ready to receive an autograft. 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 autologous skin tissue for grafting. These donor site wounds are extremely painful, prone to infection and scarring, and can themselves convert to full-thickness wounds that must then be managed to promote healing. 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 treatment of severe burns and other complex skin defects.

About StrataGraft Regenerative Skin Tissue
StrataGraft regenerative skin tissue is a viable, full-thickness product being developed for severe burns and other complex skin defects that is not yet approved by the U.S. Food and Drug Administration. It was designed to mimic natural human skin, with both dermal and fully differentiated epidermal layers. Unlike first generation products, StrataGraft skin tissue can be sutured, stapled or secured with an adhesive and remains intact in the wound bed, providing critical barrier functionality during the wound healing process. StrataGraft skin tissue is produced using NIKS^® cells grown in accordance with Good Manufacturing Practice. Because the continuous NIKS skin cell line has been thoroughly characterized, StrataGraft tissue is virus-free, non-tumorigenic, and offers batch-to-batch genetic consistency.

ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical products and therapies. 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; and analgesics and hemostasis products. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines and its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

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SOURCE Mallinckrodt plc

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