Positive phase III results for StrataGraft regenerative tissue for burn wounds. Mallinckrodt PLC

Mallinckrodt PlC announced positive top-line results from its pivotal Phase III clinical trial of its investigational StrataGraft regenerative tissue. The study, which met both primary endpoints, evaluated the efficacy and safety of a single application of StrataGraft in the treatment of deep partial-thickness thermal burns. Each study participant served as his or her own control.

Results showed that a significantly smaller area of burn wounds treated with StrataGraft tissue required autografting by three months compared to the area of burn wounds treated exclusively with autograft (p<0.0001). additionally results showed that the proportion of stratagraft-treated wounds that achieved durable wound closure at three months exceeded the pre-defined threshold for statistical significance.>

Based on the positive Phase III data, Mallinckrodt plans to submit a Biologics License Application for StrataGraft tissue to the FDA in the first half of 2020. StrataGraft tissue is an investigational product, and its safety and effectiveness have not yet been established by the FDA.