PolarityBio has completed patient enrollment in its pivotal Phase III trial evaluating SkinTE, an autologous regenerative skin multicellular therapy for diabetic foot ulcers, marking a significant milestone toward potential regulatory approval in an indication that has seen no new BLA-approved therapies in nearly three decades.
The COVER DFUS II trial enrolled 120 patients across multiple U.S. clinical sites in just 14 months, achieving an average enrollment rate of 8.6 patients per month that outpaced historical enrollment timelines for diabetic foot ulcer trials reported on clinicaltrials.gov. The multicenter randomized controlled trial randomized participants 1:1 to receive either SkinTE with standard of care or standard of care alone, with the primary efficacy endpoint measuring the incidence of complete wound closure within 12 weeks.
Breakthrough Therapy Designation Highlights Unmet Need
Earlier this year, the FDA granted Breakthrough Therapy designation to SkinTE for the treatment of Wagner Grade 1 diabetic foot ulcers. The designation is reserved for therapies with the potential to substantially improve treatment for serious or life-threatening conditions. SkinTE represents one of the few regenerative biologics pursuing BLA approval in a chronic wound indication.
"Reaching full enrollment in COVER DFUS II marks a considerable achievement for both our team and the patients we aim to serve," said John Stetson, Chief Executive Officer of PolarityBio. "We remain deeply committed to advancing SkinTE through this final stage of clinical development with the goal of delivering a transformative option to the millions of adults this disease impacts as quickly and safely as possible."
Potential for Historic Regulatory Milestone
The clinical significance of SkinTE extends beyond its therapeutic potential, as no BLA-approved therapies have been approved in a chronic wound indication since 1997. This regulatory gap underscores the substantial innovation and scientific rigor required to adequately impact diabetic foot ulcers.
Nik Sopko, Chief Operating Officer and Chief Scientific Officer of PolarityBio, emphasized the regulatory implications: "Pending positive results, COVER DFUS II could serve as the final pivotal study to support a Biologics License Application (BLA) submission with the FDA. This milestone, therefore, underscores the dedication of our team, the continued support of our clinical partners, and the urgency of innovation in wound healing."
Trial Timeline and Next Steps
The study's primary completion date and last patient visit are expected in November 2025, with final trial results anticipated in the first quarter of 2026. The Salt Lake City-based biotechnology company has an open investigational new drug application (IND) for SkinTE with the FDA and is positioning this trial as the final pivotal study needed to support a biologics license application for Wagner 1 diabetic foot ulcer indication.
SkinTE is currently available for investigational use only as PolarityBio continues to develop regenerative biologics focused on addressing unmet needs in wound healing through autologous regenerative skin multicellular therapy.
