Biopharmaceutical firm Mallinckrodt has said that a Phase III trial of its investigational StratGraft regenerative tissue met both primary endpoints of efficacy and safety.
StrataGraft regenerative tissue is being developed to reduce or eliminate autograft in patients with severe thermal burns. It is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers.
The Phase III trial assessed the efficacy and safety of a single application of StrataGraft in the treatment of deep partial-thickness thermal burns.
The study found that just 4% of the area of the StrataGraft-treated burns needed autografting after three months, and 83% of wounds treated only with StrataGraft achieved durable wound closure after three months.
Mallinckrodt said that, based on the positive Phase III data, it plans to submit a biologics license application for StrataGraft tissue to the US Food and Drug Administration in the first half of 2020.
Mallinckrodt executive vice-president and chief scientific officer Steven Romano said: “Achieving the co-primary endpoints in our pivotal Phase III trial and exceeding statistical thresholds for both endpoints represents an important development milestone for StrataGraft tissue, which has the potential to help patients suffering from deep partial-thickness thermal burns.
“Coupled with the recently announced positive Phase III results for terlipressin in hepatorenal syndrome, or HRS, type 1, these Phase III results demonstrate our ability to design and execute successful development programmes targeting complicated, serious conditions.”
StrataGraft tissue is currently being evaluated by Mallinckrodt in an ongoing Phase II trial for the treatment of adults with full-thickness burns.
The company also aims to study StrataGraft tissue in pediatric populations, and to start a continued access clinical trial under an expanded access programme in the fall of 2019.
StrataGraft tissue has secured orphan drug status from the FDA, which has also designated the treatment as a Regenerative Medicine Advanced Therapy under the provisions of the 21st Century Cures Act.