Benzinga | Jul 24, 2020 08:04AM EDT

PolarityTE Reports Results From Protocol-Specified Interim Analysis Of First 50 Patients Enrolled In Trial For SkinTE Diabetic Foot Ulcer

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.

* Demographics were well balanced between treatment groups with no statistically significant differences

* Mean wound area was 4.3 cm2 for the SkinTE plus SOC arm and 3.3 cm2 for the SOC arm (p=0.19)

* Mean wound age was 25.3 weeks for the SkinTE plus SOC arm and 22.1 weeks for the SOC arm (p=0.57)

* All SkinTE patients received only one application of the product, except two patients who received a reapplication due to inadvertent removal of the original product

* Primary Endpoint Interim Results:

* 72% of patients treated with SkinTE plus SOC achieved wound closure by 12 weeks vs 32% of patients treated with SOC alone (p=0.005)

* Secondary Endpoints Interim Results:

* Percent area reduction (PAR) was greater with SkinTE plus SOC vs SOC alone and was statistically significant at all predetermined timepoints displayed in the table below:

Percent Area Reduction (PAR)Week 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

* No significant differences between treatment groups in pain scores, wound quality of life, or Semmes-Weinstein Score

* Details regarding other secondary endpoints, including cost of treatment, will be published at a later date when analysis of data is completed

* Preliminary analysis showed that SkinTE treatment did not result in more Adverse Events (AEs) than SOC

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."

Nikolai Sopko, MD, PhD, Chief Scientific Officer at PolarityTE, added, "We are grateful for the patients' participation in this important trial. We at PolarityTE are passionately committed to helping fulfill the significant unmet needs that patients who suffer from DFUs endure. We are very pleased with these data and want to thank the investigators for all of their hard work in treating these patients."

PolarityTE will host a conference call to discuss the results with Dr. Armstrong at 4:30 pm ET on Monday, July 27th. The conference call can be accessed by calling 1-888-599-8688 (U.S. and Canada), with confirmation code 552780 and referencing "PolarityTE DFU Interim Data Conference Call." A webcast of the conference call can be accessed by using the link below.

Link to Webcast