PolarityBio Completes Enrollment in the Phase III Pivotal Study of SkinTE for Diabetic Foot Ulcers

SALT LAKE CITY, Aug. 26, 2025 (GLOBE NEWSWIRE) — PolarityBio, a clinical-stage biotechnology company focused on addressing unmet needs in wound healing through innovation in autologous regenerative skin multicellular therapy, today announced the completion of patient enrollment in COVER DFUS II, a Pivotal Phase III Multicenter Randomized Controlled Trial (RCT) investigating SkinTE® in the treatment of Wagner 1 Diabetic Foot Ulcers (DFUs). Final trial results are anticipated in the first quarter of 2026.

The trial has enrolled 120 patients across multiple U.S. clinical sites in just 14 months, at an average of 8.6 patients per month, outpacing historical enrollment timelines for DFU trials reported on clinicaltrials.gov. Participants were randomized 1:1 to receive either SkinTE with standard of care (SOC) or SOC alone. The primary efficacy endpoint is the incidence of complete wound closure within 12 weeks. The study’s primary completion date and last patient visit are expected in November 2025.

“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.”

Nik Sopko, Chief Operating Officer and Chief Scientific Officer of PolarityBio, added, “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.”

Earlier this year, the FDA granted Breakthrough Therapy designation to SkinTE for the treatment of Wagner Grade 1 DFUs. The designation is reserved for therapies with the potential to substantially improve treatment for serious or life-threatening conditions. SkinTE is one of the few regenerative biologics pursuing BLA approval in a chronic wound indication. With no BLA-approved therapies in a chronic wound indication since 1997, the innovation and scientific rigor required to adequately impact DFUs is substantial.

About PolarityBio
PolarityBio, headquartered in Salt Lake City, Utah, is a biotechnology company developing regenerative biologics. PolarityBio’s first regenerative biologic is SkinTE®, an autologous skin multicellular therapy. PolarityBio has an open investigational new drug application (IND) for SkinTE® with the U.S. Food and Drug Administration (FDA) and is now pursuing the final pivotal study on SkinTE® needed to support a biologics license application (BLA) for a Wagner 1 diabetic foot ulcer indication. SkinTE® is available for investigational use only. Learn more at www.polaritybio.com.

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