Mallinckrodt plc shared results of its Phase 1b clinical trial of StrataGraft, an investigational regenerative tissue, in Burns, the journal of the International Society for Burn Injuries (ISBI). Study data showed that treatment with a single application of StrataGraft tissue resulted in wound closure by three months in 27 of 29 study participants. None of these 27 study participants required the harvest of donor skin (autograft) by 28 days after application.Additionally, the observed characteristics of the wounds treated with StrataGraft were comparable to those treated with autograft at 12 months after treatment.The safety and effectiveness of StrataGraft have not yet been established by the U.S. Food and Drug Administration (FDA).

“In the last two to three decades, survival among burn patients has increased, but there have been few advances in the treatment of severe burn wounds. New approaches are needed to help minimize the challenges associated with autografting, the current standard of care,” says Dr. James H. Holmes IV, Director of Wake Forest Baptist Medical Center's Burn Center. “The results of the Phase 1b study of StrataGraft are encouraging and suggest that this investigational regenerative tissue could potentially reduce or eliminate the need for autografting, which may minimize pain and other risks.”

Autograft is considered to be a standard of care by many for deep partial-thickness thermal burns, complex skin injuries in which the burn extends into the lower dermis (skin below the surface of the outer layer of skin), as well as the entire epidermis (outer layer of skin). As autograft involves the surgical harvesting of healthy skin from an uninjured site on the patient and transplanting the skin graft to the injury, patients have two wounds requiring care. Not only do patients experience increased pain, but both the burn injury site and the donor site are at increased risk of infection, scarring and impaired skin function.

“Based on the positive efficacy and safety results of the Phase 1b study, we advanced the clinical development of StrataGraft tissue and recently completed enrollment in a pivotal Phase 3 trial evaluating StrataGraft in adults with deep partial-thickness thermal burns,” says Steven Romano, MD, Executive Vice President and Chief Scientific Officer at Mallinckrodt. “We are appreciative of the patients who have participated in the clinical development program for StrataGraft. If data from the pivotal Phase 3 trial are supportive, we anticipate submitting a Biologics License Application to the FDA in 2020. We believe that StrataGraft, if approved, has the potential to revolutionize the treatment of patients with deep partial-thickness thermal burns, and we are committed to bringing it to patients in need as quickly as possible.”

Top-line data from the StrataGraft Phase 3 pivotal trial are expected to be released in the next few months.