PolarityBio Gains U.S. FDA Breakthrough Therapy Status for Wagner Grade I Diabetic Foot Ulcer Treatment
Friday, February 21, 2025
PolarityBio, a biotechnology company focused on regenerative tissue products, has announced that its SkinTE treatment has received Breakthrough Therapy Status from the U.S. Food and Drug Administration (FDA) for Wagner Grade 1 Diabetic Foot Ulcers (DFU). This designation is granted to treatments for serious conditions that show promising early clinical evidence of significant improvement over existing therapies. It provides regulatory support, increased interaction with the FDA, and access to faster development pathways, including elements of the Fast Track programme.
The company is conducting the Phase III COVER DFUS II trial to assess the safety and effectiveness of SkinTE for Wagner Grade 1 DFUs, with enrolment over 75% complete. Final results are expected in the first quarter of 2026, which will provide further insights into the treatment's potential.
A previous Phase II multi-centre randomised controlled trial (NCT03881254) assessed SkinTE combined with standard care compared to standard care alone. The trial involved 100 patients across 13 sites, with 50 receiving SkinTE and standard care and 50 receiving only standard care.
Results showed that 70% of patients treated with SkinTE and standard care achieved wound closure at 12 weeks, compared to 34% in the standard care group. The percentage area reduction over eight weeks was also higher for the SkinTE group (80.7%) compared to standard care alone (26.8%). The safety analysis indicated that SkinTE did not increase adverse events compared to standard care.
Source: globenewswire.com
