An agency within the U.S. Department of Health and Human Services has awarded Stratatech, a Madison, WI-based maker of human skin tissue, $26 million in new funding.
Stratatech, which is developing cell-based regenerative skin tissue for burn victims and others, said the award will support pediatric studies of StrataGraft, the company’s flagship product.
Stratatech is a subsidiary of Mallinckrodt (NYSE: MNK). The U.K.-based pharmaceuticals giant acquired Stratatech in 2016 for $76 million upfront, plus up to $121 million in potential milestone payments.
StrataGraft is a sheet of living tissue that’s designed to coax a patient’s body into regenerating its own skin. Stratatech is currently conducting Phase 2 and Phase 3 clinical trials of StrataGraft, which are aimed at assessing the safety and efficacy of the tissue. Stratatech has said it anticipates an FDA decision on StrataGraft by 2020.
The latest funding awarded to the company comes from the Biomedical Advanced Research and Development Authority (BARDA). The agency is part of a government defense network preparing for the possibility of mass casualties due to terrorist attacks. In 2015, BARDA awarded Stratatech a five-year contract that it said could be worth up to $247 million. Stratatech said this week that to date, it has received $86 million from BARDA.
Under the terms of the contract, Stratatech agreed to stockpile skin tissue, which the federal government would purchase in the event of a terrorist attack, natural disaster, or other emergency.
“We are very pleased that BARDA has continued to see the potential benefit StrataGraft can bring as a much-needed therapeutic option for patients—both adults and children—with high unmet medical need,” Steven Romano, Mallinckrodt’s chief scientific officer, said in a news release.
Traditionally, patients with deep partial-thickness burns are treated with an autograft. That’s a procedure in which tissue from another part of a patient’s body is surgically removed and grafted onto the wounded area. By contrast, StrataGraft is living tissue made from a type of human keratinocyte progenitor cells, cells that go on to form skin. StrataGraft tissue can be sutured, stapled, or put into place using an adhesive.
In July 2017, the FDA designated StrataGraft as a Regenerative Medicine Advanced Therapy (RMAT). Drugs that treat rare diseases or life-threatening conditions can be placed on a faster regulatory pathway. RMAT creates that faster pathway for regenerative medicine products, including cell therapies and tissue-based products like StrataGraft. The designation allows companies to speak with the FDA earlier and more frequently during the regulatory process.
Stratatech was founded in 2000 by B. Lynn Allen-Hoffman, a researcher and professor at the University of Wisconsin-Madison. She is now senior vice president of regenerative medicine at Mallinckrodt.