Mallinckrodt Announces Publication of Phase 3 STRATA2016 Study in Burns

Wake Forest Baptist Trauma Surgery Professor Co-Lead Investigator for the Study

July 8, 2021

Mallinckrodt plc, a global biopharmaceutical company, today announced publication of results from the pivotal Phase 3 STRATA2016 clinical trial of StrataGraft® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat), which is approved for the treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns).  The data were published in Burns, a peer-reviewed journal of the International Society for Burn Injuries. The trial, which evaluated the efficacy and safety of a single application of StrataGraft in adult patients with deep partial-thickness thermal burns, achieved both co-primary efficacy endpoints.

The Phase 3 clinical trial was supported by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS). BARDA is providing funding and technical support for the continued development of StrataGraft under Project BioShield Contract No. HHSO100201500027C.

The published data showed that 96% of the burn sites treated with StrataGraft did not require autografting, and 83.1% of patients achieved durable wound closure of the StrataGraft treatment site without autografting by three months. As a reference, 86% of patients achieved durable wound closure of the autograft control sites. The significant reduction in use of autograft in patients treated with StrataGraft resulted in favorable outcomes in the secondary efficacy endpoints of donor site pain and donor site cosmesis (preservation or restoration of physical appearance). Additionally, cosmesis at the StrataGraft and autograft treatment sites was clinically similar at 12 months.

"Surgical advances have improved survival rates in patients with severe burns. However, new treatments are needed that can help reduce or eliminate autografting, as the need to harvest healthy skin tissue can lead to pain, itching, scarring and impaired function at the donor site," said James H. Holmes, IV, MD, co-lead investigator of STRATA2016 and professor of trauma surgery at Wake Forest School of Medicine. "We were encouraged to see in the Phase 3 trial that treatment with StrataGraft eliminated donor tissue harvest in all but three of the 71 study participants. Now that StrataGraft is approved, burn surgeons have an alternative biologic treatment option for patients with deep partial-thickness burns."

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