PolarityTE Announces Positive Top-Line Data from Interim Analysis of SkinTE Diabetic Foot Ulcer Trial
PolarityTE, Inc. (Nasdaq: PTE) announced positive results from a protocol-specified interim analysis of the first 50 patients enrolled in a multi-center randomized controlled trial evaluating treatment of Diabetic Foot Ulcers with SkinTE plus standard of care (SOC) vs SOC alone (NCT03881254). 50 patients were evaluated across 13 sites with 25 patients receiving SkinTE plus SOC and 25 patients receiving only SOC.
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Week |
Percent Area Reduction (PAR) |
p-value
SkinTE+SOC
SOC
4
78.6%
24.0%
0.00021
6
83.2%
43.8%
0.004
8
86.6%
47.2%
0.002
12
88.2%
49.6%
0.012
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These data will be presented by the Study Chair, David Armstrong, DPM, MD, PhD, Professor of Clinical Surgery at the Keck School of Medicine, at the SAWC Spring 2020 Virtual Conference held July 24-26, 2020. Dr. Armstrong commented, “Diabetic foot ulcers exact a substantial toll on the patients who suffer from them in terms of the impact to their daily lives. Many of these patients are on a path to even more serious, life-threatening, and morbidity-increasing procedures such as amputations. These patients have historically lacked access to treatments that offer durable closure of these hard-to-treat wounds.” Dr. Armstrong continued, “I am very encouraged by the positive results from this interim analysis. The data show a statistically significant difference favoring PolarityTE’s autologous skin construct, SkinTE, in the primary endpoint of wounds closed at 12 weeks, and in percent area reduction of wounds at each time point measured. We look forward to completing the trial and reading out the full data set in due course.”