FDA Grants Breakthrough Therapy Designation to SkinTE for Diabetic Foot Ulcers

The FDA has granted breakthrough therapy designation (BTD) to SkinTE (PolarityTE), a novel autologous heterogeneous skin construct for skin regeneration, indicated to treat Wagner grade 1 diabetic foot ulcers (DFU).^1,2

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“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,” Nik Sopko, chief operating officer and chief scientific officer of PolarityBio, said in a news release.¹

Around one-third of individuals with diabetes develop a foot ulcer and DFU is reported to impact about 18.9 million individuals worldwide and about 1.6 million US individuals annually.³

DFU is an open wound on the foot that develops among individuals with type 1 or type 2 diabetes. Diabetic neuropathy can cause decreased sensation in the feet, making it difficult to feel injuries like punctures from objects in shoes, which can lead to foot ulcers. This, combined with foot deformities and dry skin, can cause calluses to form. With repetitive stress or minor injuries, these calluses can then turn into ulcers. The ulcers commonly occur when hemorrhaging develops beneath a callus, then the callus wears away and exposes deeper tissues of the foot.³

Using the Wagner system to classify the grade of DFU, grade 1 DFU are superficial ulcers that include the full skin thickness but no underlying tissues.⁴ If approved, SkinTE could aid grade 1 DFU by regenerating and activating the tissues surrounding the wound to heal it completely.⁵

The BTD was granted based on data from the phase 2 multi-center randomized controlled trial (NCT03881254) that evaluated SkinTE treatment plus standard of care (SOC) compared to SOC alone among individuals with grade 1 DFU. A total of 100 individuals across 13 sites were included in the study, with 50 receiving SkinTE plus SOC and 50 receiving SOC only. The study measured the percentage of wounds closed at 12 weeks—defined as 100% skin regrowth without drainage—and confirmed at 2 visits 2 weeks apart as its primary end point. The researchers tracked the percentage of wound area reduction at 4, 6, 8, and 12 weeks as a secondary end point.^1,6

The results demonstrated that at week 12, about 70% of individuals that received SkinTE plus SOC had wound closure, compared with 34% of individuals that received SOC alone (P = .00032). Further results were found over 8 weeks; the percentage area reduction (PAR) was significantly greater for individuals in the SkinTE plus SOC group (80.7%) compared with the SOC group (26.8%).¹

The study authors noted that individuals treated with SkinTE plus SOC did not experience more adverse events than SOC alone.¹

The findings suggest that 1 application of SkinTE is an effective treatment option for grade 1 DFC; however, further research is needed to assess its use on more severe diabetic foot wounds.⁶

“Our ongoing COVER DFUS II Phase [3] 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,” Sopko said in a news release.¹

REFERENCES

1. PolarityBio Receives U.S. FDA Breakthrough Therapy Designation for Treatment of Wagner Grade I Diabetic Foot Ulcers (DFU). GlobeNewswire. News release. Published February 20, 2025. Accessed February 21, 2025. https://www.globenewswire.com/news-release/2025/02/20/3029651/0/en/PolarityBio-Receives-U-S-FDA-Breakthrough-Therapy-Designation-for-Treatment-of-Wagner-Grade-I-Diabetic-Foot-Ulcers-DFU.html

2. PolarityTE Announces FDA Regenerative Medicine Advanced Therapy Designation Granted to SkinTE. PR Newswire. News release. Published May 13, 2022. Accessed February 21, 2025. https://www.prnewswire.com/news-releases/polarityte-announces-fda-regenerative-medicine-advanced-therapy-designation-granted-to-skinte-301546677.html

3. What Are Diabetic Foot Ulcers? JAMA Network. News release. Published November 17, 2023. Accessed February 21, 2025. https://jamanetwork.com/journals/jama/fullarticle/2812203#:~:text=Diabetic%20foot%20ulcers%20are,foot%20or%20the%20whole%20foot

4. Diabetes: Foot Ulcers and Amputations. American Family Physician. News release. Published October 15, 2009. Accessed February 21, 2025. https://www.aafp.org/pubs/afp/issues/2009/1015/p789.html#:~:text=Definition-,Diabetic%20foot%20ulceration%20is%20full%2Dthickness%20penetration%20of%20the%20dermis,previous%20foot%20ulceration%20or%20amputation

5. Evolution of Healing via SkinTE®. PolarityBio. Accessed February 21, 2025. https://www.polaritybio.com/

6. 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. Internal Wound Journal. Published July 4, 2023. Accessed February 21, 2025. https://onlinelibrary.wiley.com/doi/10.1111/iwj.14301