PolarityBio’s SkinTE received Breakthrough Therapy Designation from the FDA for treating Wagner Grade 1 Diabetic Foot Ulcers (DFUs). This designation stems from positive Phase II trial data showing SkinTE’s potential to significantly improve healing compared to standard care. The FDA awards this designation to expedite the development and review of therapies for serious conditions where preliminary evidence suggests a substantial improvement over available treatments.
This breakthrough designation is crucial for DFU patients, who often face prolonged healing times, increased risk of infection, and potential amputation. Current treatment options often prove inadequate, highlighting the urgent need for more effective therapies. SkinTE’s potential to accelerate healing could significantly improve patient outcomes and reduce the burden of this debilitating condition.
In a Phase II trial, 70% of patients treated with SkinTE plus standard care achieved wound closure at 12 weeks, compared to only 34% in the standard care group. Furthermore, the SkinTE group experienced an 80.7% reduction in wound area over eight weeks, versus 26.8% in the control group. Importantly, SkinTE demonstrated a comparable safety profile to standard care. PolarityBio’s Phase III trial (COVER DFUS II) is currently over 75% enrolled, with topline interim results anticipated in Q1 2025.
This breakthrough designation accelerates SkinTE’s development trajectory and signifies a potential paradigm shift in DFU treatment. Positive results from the ongoing Phase III trial could pave the way for FDA approval and make this promising therapy available to patients, significantly impacting the DFU treatment landscape.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
