PolarityTE’s SkinTE Meets Endpoints in Diabetic Foot Ulcer Trial

July 28, 2021—PolarityTE, Inc. announced final data from a multicenter randomized controlled trial evaluating treatment of diabetic foot ulcers with its investigational SkinTE product plus standard of care (SOC) versus SOC alone. David Armstrong, DPM, MD, served as Principal Investigator of the trial.

According to the company, the “SkinTE in the Treatment of Diabetic Foot Wounds” trial met the primary endpoint of wound closure at 12 weeks and secondary endpoint of percent area reduction (PAR) assessed at 4, 6, 8, 10, and 12 weeks.

The company incorporated data from the trial as part of its Investigational New Drug application, which was submitted to the FDA on July 23, 2021. The study will not considered to be a registrational trial as part of a Biologic License Application.

Investigators evaluated 100 patients across 13 sites. Patients were randomized 1:1 with 50 patients receiving SkinTE plus SOC and 50 patients receiving SOC alone. Of patients receiving SkinTE plus SOC, 90% (45/50) received a single application of SkinTE.

The investigators found that treatment with SkinTE plus SOC increased the odds of wound closure 5.37 times versus SOC (P = .001).

For the primary endpoint, wound closure at 12 weeks was achieved in 70% (35/50) of patients receiving SkinTE plus SOC versus 34% (17/50) of patients receiving SOC alone (P = .00032).

For the secondary endpoint, PAR was significantly greater for the SkinTE plus SOC treatment group versus SOC alone (P = .009). At 4, 6, 8, 10, and 12 weeks, respectively, the PAR mean (standard deviation) values were 74.0% versus 22% (149.92); 82.9% (26.35) versus 21.2% (160.6); 80.7% (35.16) versus 26.8% (147.42); 79.7% (54.07) versus 45.6% (114.18); and 84.3% (39.46) versus 50.5% (92.24).

Additionally, the investigators reported that 148 adverse events (AEs) were allocated to 49 patients. The SkinTE plus SOC treatment group had 66 AEs allocated to 21 patients. The SOC-alone treatment group had 82 AEs allocated to 28 patients. There were 26 serious AEs, 12 in the SkinTE plus SOC treatment group (seven patients) and 14 in the SOC treatment group (nine patients).

Wound size for the SkinTE plus SOC treatment group was 3.5 cm² versus 3.2 cm² for the SOC treatment group (P = .46).

The company noted that a comparison by treatment group for wound-related variables showed that variables were balanced between groups except for a sharp debridement count, which was marginally statistically significantly higher in the SOC group compared to the SkinTE group, because of shorter wound closure times in the SkinTE group.

Additionally, PolarityTE announced a randomized controlled trial evaluating SkinTE versus SkinTE plus SOC in venous leg ulcers (VLUs) has been completed with a total of 29 enrolled patients. Topline data from the VLU trial will be announced in the second half of 2021.

PolarityTE manufactures SkinTE from the patient’s own tissue and uses the patient’s own body to support the regenerative process. From a small piece of healthy autologous tissue, an easily deployable, dynamic, and self-propagating product is created that is designed to regenerate the target tissues. SkinTE is in the development stage and is not approved or available for clinical use, advised the company.