Manufacturing issues are common with regenerative medicines. And so it goes for PolarityTE's investigational new drug submission for SkinTE.
On Tuesday the Salt Lake Salt Lake City biotech revealed that it has put its investigational new drug (IND) application on hold in chronic cutaneous ulcers to address chemistry, manufacturing and control (CMC) issues raised by the agency.
The FDA wants a more clear idea of the cellular makeup of SkinTE and how that relates to the product’s effectiveness, Richard Hague, president and COO of Polarity said in an interview. The company has submitted data to the FDA to address those concerns, he added.
On its website, PolarityTE describes SkinTE as "donated human tissue for autologous, single application use only." The company manufactures the product from a patient's own tissue, using the "patient's own body to support the regenerative process," the biotech says.
The FDA will explain the action further when it issues a clinical hold letter to the company by Sept. 21. PolarityTE submitted its application on July 23.
Despite the FDA setback, PolarityTE still sees a big opportunity for its regenerative medicine.
“You have everything from a silver-dollar-sized wound to a wound that covers 70% of a patient and there’s everything in between," Hague said. ... “The beauty of SkinTE is that we’ve shown this product can work in all of those different types of wounds and can be utilized in multiple points of care."
Still, the company will have to convince the FDA of its treatment's effectiveness and explain its manufacturing process to the regulator.
PolarityTE’s stock fell about 9% on Tuesday after the news broke.