Mallinckrodt says StrataGraft to be evaluated in Phase 3 trial
"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," said Steven Romano, M.D., 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.