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Mallinckrodt completes enrollment in late-stage StrataGraft trial

  • Stratatech, a Mallinckrodt (NYSE:MNK) company, has completed patient enrollment in its ongoing Phase 3 clinical trial of StrataGraft, an investigational regenerative skin tissue.
  • The study is evaluating the efficacy and safety of StrataGraft in autologous skin regeneration of complex skin defects due to severe thermal burns. 71 patients were enrolled.
  • The trial's primary endpoints include autograft sparing and durable wound closure.
  • Top-line data are expected by the end of 2019. The company anticipates submitting a BLA in 2020 if data is supportive.

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