The biopharmaceutical company Mallinckrodt announced positive top-line results from its phase 3 clinical trial for StrataGraft regenerative tissue and plans to submit a biologics license application to the FDA in the first half of 2020.
StrataGraft is an investigational treatment in development for patients with severe thermal burns to eliminate or reduce autograft. The engineered, bilayer tissue is designed to mimic human skin, according to a company press release.
Both primary endpoints were met in the study, which evaluated the efficacy and safety of a single application of StrataGraft for the treatment of deep partial-thickness thermal burns.
The open-label, randomized controlled, multicenter phase 3 trial enrolled 71 adults with 3% to 49% total body surface area complex skin defects by thermal burns for which surgical excision and autografts were indicated. Two similar areas of burn injury on the same study participant (an intrapatient control) were randomly assigned to autograft or StrataGraft. Overall, 4% of the StrataGraft-treated sites required autografting by 3 months.
In the StrataGraft-treated sites, the researchers reported a 98% reduction in the area necessitating autograft compared with control-treated sites (P < .0001).
The majority (83%) of StrataGraft-treated burn wounds achieved durable wound closure 3 months after placement (95% CI, 74.4-91.8).
The safety profile was comparable to autograft.
Currently, the company is evaluating StrataGraft in an ongoing phase 2 trial among adults with third-degree burns and plans to study the tissue in pediatric populations as well. Mallinckrodt also plans to launch a continued access clinical trial under an expanded access program in the fall.
StrataGraft is an investigational product and its safety and effectiveness have not yet been evaluated by the FDA. StrataGraft has been granted orphan drug status and designation by the agency as a regenerative medicine advanced therapy under the 21st Century Cures Act.