Mallinckrodt PLC said its therapy StrataGraft helped treat burn wounds and met the main goals of a late-stage study.
The U.K.-based drugmaker evaluated the efficacy and safety of a single application of StrataGraft in a phase 3 trial dubbed STRATA2016. StrataGraft is a human skin substitute that is being developed to reduce or eliminate autograft — the process of surgically harvesting healthy skin from a burn patient's uninjured site so it can be transplanted to an injured area.
Autograft is considered to be a standard of care for deep partial-thickness thermal burns but can cause complications as the second wound created by removing healthy skin can be even more painful than the burn wound itself.
Results showed that patients treated with StrataGraft tissue required autografting at only 4% of affected areas after three months of treatment. Furthermore, 83% of burn wounds treated with StrataGraft achieved durable wound closure, exceeding a pre-defined benchmark but lower than the 86% achieved in patients receiving autograft.
The safety profile of StrataGraft was comparable to that of autograft, and itching was the most commonly reported treatment-emergent adverse event.
Mallinckrodt — which is reportedly considering options of restructuring and even bankruptcy — said it plans to submit an application with the U.S. Food and Drug Administration in the first half of 2020 seeking approval of StrataGraft.
The U.S. Biomedical Advanced Research and Development Authority has been providing funding to Mallinckrodt to develop StrataGraft. The therapy is also being evaluated in an ongoing phase 2 trial to treat adults with third-degree burns. In addition, the company plans to study StrataGraft in children.
