PolarityBio Gets Breakthrough Status for SkinTE

FDA has granted PolarityBio a breakthrough therapy designation for SkinTE for treating Wagner Grade 1 diabetic foot ulcers (DFU). SkinTE is a human cellular and tissue-based product derived from a patient’s own skin to regenerate full-thickness skin with all of its layers (epidermis, dermis and hypodermis) and appendages, including hair follicles and glands.

The designation was based on data from a Phase 2 trial evaluating treatment of DFUs with SkinTE plus standard of care (SOC) vs SOC alone (NCT03881254) in 100 patients, which the company says showed that 70% of patients receiving SkinTE plus SOC had wound closure at 12 weeks versus 34% of patients receiving SOC alone. Additionally, the “percentage area reduction” over eight weeks was significantly greater for SkinTE-treated patients, PolarityBio says. The company has an ongoing Phase 3 trial (COVER DFUS II) that is over 75% enrolled and final results are expected in 2026.