PolarityBio Completes Phase III Trial of SkinTE for Diabetic Foot Ulcers, Targets First BLA Approval Since 1997
核心洞察
PolarityBio (搜索) completed its COVER DFUS II Phase III trial for SkinTE, an autologous skin multicellular therapy for Wagner 1 diabetic foot ulcers (搜索), with the last patient visit occurring on November 12, 2025.
The registrational study enrolled 120 patients across multiple U.S. sites in 14 months and is designed to support a Biologics License Application for what could be the first BLA-approved therapy in chronic wound indication since 1997.
SkinTE received FDA Breakthrough Therapy designation earlier this year, highlighting its potential to substantially improve treatment for diabetic foot ulcers (搜索) that affect millions of patients worldwide.
PolarityBio (搜索) has successfully completed enrollment and follow-up for its pivotal Phase III trial evaluating SkinTE, an autologous skin multicellular therapy for diabetic foot ulcers (搜索), marking a significant milestone in chronic wound care development. The COVER DFUS II trial reached its last patient visit on November 12, 2025, positioning the company to potentially file the first Biologics License Application (BLA) for a chronic wound therapy since 1997.
Breakthrough Therapy Advances Toward Regulatory Filing
The Salt Lake City-based biotechnology company announced completion of its registrational study designed to support BLA filing for SkinTE as a first-in-class autologous skin multicellular therapy. Earlier this year, the FDA granted SkinTE Breakthrough Therapy designation for treating Wagner Grade 1 diabetic foot ulcers (搜索), a status reserved for therapies with potential to substantially improve treatment for serious or life-threatening conditions.
"Ideas are common, but taking those ideas and studying them to prove their validity is much less common," said Dr. Robert Kirsner, Chairman and Harvey Blank Professor of the Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery at the University of Miami Miller School of Medicine, and Chair of the COVER DFUS II study. "Patient care depends on this, and the COVER II trial is the type of work needed to help reduce the burden and impact of diabetic foot ulcers (搜索) on patients and society."
Robust Trial Design and Enrollment Success
The COVER DFUS II trial enrolled 120 patients across multiple U.S. clinical sites in just 14 months, averaging 8.6 patients per month and outpacing historical enrollment timelines for diabetic foot ulcer trials reported on clinicaltrials.gov. Participants were randomized 1:1 to receive either SkinTE with standard of care or standard of care alone, with follow-up extending 24 weeks post-randomization.
The study implemented stringent inclusion criteria, requiring participants to have diabetic foot ulcers (搜索) present for at least four weeks prior to screening that had failed to heal with other treatments. Additionally, all participants underwent a two-week run-in period with rigorous standard of care, qualifying for randomization only if their ulcer size remained stable within 30% during this period.
The primary efficacy endpoint measures the incidence of complete wound closure within 12 weeks. Secondary endpoints include time to healing, percent area reduction, total number of in-clinic or hospital days related to the index ulcer, total days of controlled ankle motion boot use, and proportion of subjects experiencing treatment-emergent adverse events.
Patient Experience and Clinical Impact
Patient testimonials from the trial highlight the therapy's potential impact. One participant treated with SkinTE at Dr. Jason Hanft's site reported: "Everything was excellent! Thanks to Dr. Hanft's care and supervision, my wound healed. I had an extra-large wound, and thankfully, my doctor recommended that I participate in this research trial. I really hope the study is a success so other people can share my experience. I had no pain, and I am extremely appreciative that my foot was saved."
Dr. Jason Hanft, a principal investigator at one of the COVER DFUS II clinical trial sites, commented: "I extend sincere congratulations to PolarityBio (搜索) for reaching the last patient visit in their Phase III trial for SkinTE as a diabetic foot ulcer treatment. This marks an impressive milestone and a significant step forward in advancing care for patients with chronic wounds (搜索)."
Addressing Critical Unmet Medical Need
The significance of SkinTE's development is underscored by the absence of BLA-approved therapies in the chronic wound indication since 1997. This 28-year gap highlights the substantial innovation and scientific rigor required to adequately impact diabetic foot ulcers (搜索), making SkinTE one of the few regenerative biologics pursuing BLA approval in this challenging therapeutic area.
Ashlee Fishleigh, Chief Clinical Officer of PolarityBio (搜索), emphasized the collaborative effort behind the trial's success: "I want to personally thank our clinical research investigators and the dedicated research coordinators who have supported this program. Your expertise, commitment to high-quality research, and steady focus on patient safety and care have been critical in moving this work forward."
Timeline and Next Steps
Final trial results are anticipated in the first quarter of 2026, which will inform the company's regulatory strategy for BLA submission. PolarityBio (搜索) currently maintains an open investigational new drug application with the FDA for SkinTE, positioning the company to advance toward potential market approval pending positive trial outcomes.
The completion of COVER DFUS II represents a critical advancement in regenerative medicine approaches to chronic wound healing, potentially offering new hope for patients suffering from diabetic foot ulcers (搜索) who have limited therapeutic options under current standard of care protocols.