FDA Accepts PolarityBio’s BLA for SkinTE in Diabetic Foot Ulcers

PolarityBio, a biotechnology company based in Salt Lake City, Utah, has announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for SkinTE®. The application is for the treatment of Wagner Grade 1 diabetic foot ulcers (DFUs) and has been granted Priority Review, setting a Prescription Drug User Fee Act (PDUFA) target action date of March 16, 2027.

SkinTE® is an autologous cutaneous multicellular therapy that PolarityBio is developing to address unmet needs in wound healing. The company submitted the BLA based on positive results from COVER DFUS II, a pivotal Phase III randomized controlled trial. The trial evaluated SkinTE® in combination with standard of care (SOC) compared to SOC alone for Wagner Grade 1 DFUs. The primary efficacy endpoint was complete wound closure within 12 weeks, which the trial met.

The COVER DFUS II trial enrolled 120 patients across multiple U.S. clinical sites over 14 months. Participants were randomized 1:1 to receive either SkinTE® with SOC or SOC alone. The study also showed that adding SkinTE® to standard of care improved complete wound closure at 12 weeks and reduced adverse events. These findings are being prepared for peer-reviewed publication.

Robert Kirsner, M.D., Ph.D., chair of the COVER DFUS II trial, commented, "A six-month review timeline matters in a population where every week that an ulcer stays open carries risk of infection, hospitalization, and amputation. In COVER DFUS II, adding SkinTE® to standard of care both improved complete wound closure at 12 weeks and reduced adverse events. Closure paired with better overall outcomes for patients is the combination clinicians managing difficult-to-heal diabetic foot ulcers need."

With a definitive PDUFA target action date established, PolarityBio is advancing its market access and commercial readiness strategy. The company has built manufacturing, medical affairs, and market access capabilities in parallel with the clinical program, and that work continues. PolarityBio's lead product, SkinTE®, is currently available for investigational use only through an Expanded Access Program.

The BLA is supported by positive results from COVER DFUS II, which met its primary efficacy endpoint of complete wound closure within 12 weeks. Additional findings, including infection and safety data, are being prepared for peer-reviewed publication. PolarityBio's commercial readiness activities are focused on ensuring that the company is well-positioned to serve patients if SkinTE® is approved.