PolarityBio announced today that its regenerative tissue product SkinTE has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration for treating Wagner Grade 1 Diabetic Foot Ulcers (DFU). This prestigious designation, aimed at expediting development and review of promising treatments, acknowledges SkinTE's potential to substantially improve upon existing therapies for this serious condition.
Compelling Phase II Results Drive Breakthrough Status
The breakthrough designation was supported by impressive data from a multi-center randomized controlled Phase II trial involving 100 patients across 13 sites. The study demonstrated that 70% of patients receiving SkinTE plus standard of care achieved wound closure at 12 weeks, compared to only 34% in the standard of care group (p=0.00032). Additionally, the percentage area reduction over 8 weeks was significantly higher in the SkinTE treatment group at 80.7%, versus 26.8% for standard care alone (p=0.009).
"We are thrilled that the FDA has granted Breakthrough Therapy Designation to SkinTE for the treatment of Wagner Grade 1 Diabetic Foot Ulcers," said Nik Sopko, Chief Operating Officer and Chief Scientific Officer of PolarityBio. "This designation underscores the unmet medical need for patients with DFUs and the potential therapeutic significance of SkinTE."
Advancing Toward Phase III Completion
The company's ongoing COVER DFUS II Phase III pivotal trial has already achieved over 75% enrollment, with final results anticipated in Q1 2026. This trial will further evaluate the safety and efficacy of SkinTE in treating Wagner 1 DFUs, building upon the promising Phase II safety profile where SkinTE treatment did not result in more adverse events than standard care.
Regulatory Implications and Development Path
The Breakthrough Therapy Designation provides PolarityBio with enhanced regulatory support, increased FDA engagement, and access to expedited development pathways. This status could potentially accelerate SkinTE's journey toward a biologics license application (BLA) for chronic cutaneous ulcer indication.
Clinical Development Strategy
PolarityBio, headquartered in Salt Lake City, Utah, is pursuing a comprehensive development program for SkinTE under an open investigational new drug application. The current Phase III trial represents the first of two pivotal studies required to support the BLA, reflecting the company's systematic approach to bringing this innovative treatment to patients with difficult-to-treat diabetic foot ulcers.
