PolarityBio Receives U.S. FDA Breakthrough Therapy Designation for Treatment of Wagner Grade I Diabetic Foot Ulcers (DFU)

• The FDA has granted Breakthrough Therapy Designation for SkinTE based on key positive data from the Phase II study in Wagner1 DFUs highlighting the ongoing unmet need in this patient population
• FDA Breakthrough Therapy Designation is one of the FDA’s most significant regulatory distinctions, aimed at expediting the development and review of treatments for serious or life-threatening conditions that demonstrate substantial potential to improve upon existing therapies
• SkinTE continues to advance in clinical development; Phase3 COVER DFUS II trial is over 75% enrolled with topline interim results expected in Q1 2025

SALT LAKE CITY, Feb. 20, 2025 (GLOBE NEWSWIRE) — PolarityBio, a clinical-stage biotechnology company developing regenerative tissue products, announced today that SkinTE has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of Wagner Grade 1 Diabetic Foot Ulcers (DFU). The FDA grants BTD to drug candidates for serious or life-threatening conditions that have preliminary clinical evidence demonstrating potential to provide substantial improvement over existing therapies. The designation provides enhanced regulatory support, increased engagement with the FDA and additional opportunities to engage with the FDA and access to expedited development pathways, including features of the Fast Track program.

“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, the potential therapeutic significance of SkinTE, as well as potentially facilitating timely access to patients. Sopko continued, “Our ongoing COVER DFUS II Phase III Pivotal Trial evaluating the safety and efficacy of SkinTE to treat Wagner 1 DFUs is over 75% enrolled and we anticipate final results in Q1 2026, which will help us further understand the role SkinTE can play in treating this serious condition.”

Data from the Phase II multi-center randomized controlled trial evaluating treatment of Wagner I Diabetic Foot Ulcers with SkinTE® plus standard of care (SOC) vs SOC alone (NCT03881254) that supported Breakthrough Therapy Designation is summarized below.

100 patients were evaluated across 13 sites with 50 patients receiving SkinTE plus SOC and 50 patients receiving only SOC.

• Primary Endpoint: 70% (35/50) of patients receiving SkinTE plus SOC had wound closure at 12 weeks versus 34% (17/50) of patients receiving SOC alone—p=0.00032

• Secondary Endpoint: Percentage Area Reduction (PAR) over 8 weeks was significantly greater for the SkinTE plus SOC treatment group (80.7%) vs SOC alone (26.8%)—p=0.009

• Safety Analysis: SkinTE treatment did not result in more Adverse Events (AEs) than SOC

Open access to the published study results in full detail can be found at the following citation:

Armstrong DA, et al. A multicenter, randomized controlled clinical trial evaluating the effects of a novel autologous heterogeneous skin construct in the treatment of Wagner one diabetic foot ulcers: Final analysis. Int Wound J. 2023 Dec;20(10):4083-4096. doi: 10.1111/iwj.14301.

About PolarityBio

PolarityBio, headquartered in Salt Lake City, Utah, is a biotechnology company developing regenerative tissue products. PolarityBio’s first regenerative tissue product is SkinTE®. 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 first of two pivotal studies on SkinTE® needed to support a biologics license application (BLA) for a chronic cutaneous ulcer indication. SkinTE® is available for investigational use only. Learn more at www.PolarityTE.com.

Parker Scott
IR@polarityTE.com
801-455-1440