Mallinckrodt plc (NYSE: MNK), a leading global specialty pharmaceutical company, today announced that Stratatech, a Mallinckrodt company, has completed patient enrollment in its ongoing pivotal Phase 3 clinical trial of StrataGraft®, an investigational regenerative skin tissue. The multicenter study is evaluating the efficacy and safety of StrataGraft in the promotion of autologous skin regeneration of complex skin defects due to severe thermal burns that contain intact dermal elements (also known as deep partial-thickness burns). The safety and effectiveness of StrataGraft have not yet been established by the U.S. Food and Drug Administration (FDA). Investigators enrolled 71 patients across 12 clinical sites.
“This is an exciting milestone for StrataGraft, an investigational therapy that has the potential to revolutionize the standard of care for patients with severe burns,” said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt. “We believe that StrataGraft, if approved, will advance the treatment of these severe injuries by providing patients with an alternative to autograft.”
Autograft, the current standard of care, involves surgically removing a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound. Patients and clinicians report significant morbidity associated with the resulting donor site wounds, which are created during surgical removal of healthy skin. Donor site wounds are extremely painful, and can create risks of additional scarring and infection.