Mallinckrodt (MNK) Completes Enrollment In Skin Tissue Study
Zacks Investment Research | Apr 14, 2019 10:50PM ET
Mallinckrodt plc (NYSE:MNK) announced that Stratatech (acquired in 2016) has completed enrollment in the phase III study on its investigational regenerative skin tissue, StrataGraft. The study is designed to evaluate the safety and efficacy of StrataGraft regenerative skin tissue for promoting autologous skin regeneration in patients with thermal burns that contain intact dermal elements (also known as deep partial-thickness burns).
The ongoing pivotal study enrolled 71 patients across 12 sites in the United States.
Top-line data from the study is expected by the end of this year. The primary endpoints of the study include autograft sparing and durable wound closure. Mallinckrodt plans to file a Biologics License Application (BLA) in 2020, if outcomes from the program are found to be supportive.
Notably, StrataGraft enjoys an orphan drug status and was among the first products designated as Regenerative Medicine Advanced Therapy (RMAT) by the FDA under the provisions of the 21st Century Cures Act.
Currently, Autograft is the standard of care for treating skin defects in patients with thermal burns. If approved, StrataGraft will be an alternative to autograft for the given patient population.
Shares of Mallinckrodt have soared 56.9% so far this year against the Zacks Investment Research
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