SkinTE® Met Primary and Secondary Endpoints in Final Analysis from Diabetic Foot Ulcer Trial

Rhea-AI Summary

PolarityTE, Inc. (Nasdaq: PTE) revealed final results from a trial assessing SkinTE® for treating Diabetic Foot Ulcers (DFU). The study achieved its primary endpoint with 70% closure at 12 weeks for SkinTE plus standard of care (SOC), compared to 34% for SOC alone (p=0.00032). Additionally, patients using SkinTE showed a significant Percent Area Reduction across multiple weeks (p=0.009). While the trial demonstrated strong efficacy, it will not be part of a Biologic License Application. PolarityTE also announced plans for further trials.

Positive

• 70% wound closure at 12 weeks for SkinTE plus SOC vs 34% for SOC alone.
• Significant Percent Area Reduction (p=0.009) for SkinTE plus SOC.
• 5.37 times higher odds of wound closure with SkinTE compared to SOC.

Negative

• 148 adverse events reported; 66 in SkinTE group, 82 in SOC group.
• Study will not be part of a Biologic License Application.

PolarityTE, Inc. (Nasdaq: PTE) today announced final data from a multi-center randomized controlled trial evaluating treatment of Diabetic Foot Ulcers (DFU) with its investigational product SkinTE® plus standard of care (SOC) vs SOC alone (NCT03881254). The 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. 100 participants were evaluated across 13 sites with 50 participants receiving SkinTE plus SOC and 50 receiving SOC alone. PolarityTE is pleased to announce today the final analysis of the full data set, which includes:

• Primary Endpoint: 70% (35/50) of participants receiving SkinTE plus SOC had wound closure at 12 weeks versus 34% (17/50) of participants receiving SOC alone (p=0.00032)
• Secondary Endpoint: Percent Area Reduction (PAR) assessed at 4, 6, 8, 10, and 12 weeks was significantly greater for the SkinTE plus SOC treatment group vs SOC alone (p=0.009)
• 90% (45/50) of SkinTE plus SOC treated participants received a single application of SkinTE
• Treatment with SkinTE plus SOC increased the odds of wound closure by 5.37 times versus SOC (p=0.001)

Mean (SD) values for PAR at weeks 4, 6, 8, 10, and 12 by treatment group

Week	SkinTE	SOC
4	74.0 (27.63)	22.0 (149.92)
6	82.9 (26.35)	21.2 (160.60)
8	80.7 (35.16)	26.8 (147.42)
10	79.7 (54.07)	45.6 (114.18)
12	84.3 (39.46)	50.5 (92.24)

• 148 Adverse Events (AEs) were allocated to 49 subjects. The SkinTE plus SOC treatment group had 66 AEs allocated to 21 subjects while the SOC treatment group had 82 AEs allocated to 28 subjects. There were 26 Serious Adverse Events (SAEs), 12 in the SkinTE plus SOC treatment group (7 subjects) and 14 in the SOC treatment group (9 subjects).
• Wound size for the SkinTE plus SOC treatment group was 3.5 cm² versus 3.2 cm² for the SOC treatment group (p=0.46). A comparison by treatment group for wound-related variables showed that variables were well balanced between groups with the exception of sharp debridement count, which was marginally statistically significantly higher in the SOC group compared to the SkinTE group, due to shorter wound closure times in the SkinTE group.

While this DFU study will not be considered to be a registrational trial as part of a Biologic License Application (BLA), the Company incorporated data from the trial as part of its Investigational New Drug (IND) application to the FDA, which was submitted on July 23, 2021.

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 participants. Topline data from the VLU trial will be announced via press release in the second half of 2021.

Nikolai Sopko, MD, PhD commented, “Every 1.2 seconds someone in the U.S. develops a diabetic foot ulcer and the full results of this study further solidify our belief that SkinTE has significant potential to positively impact the lives of patients suffering from debilitating wounds. We are incredibly grateful to all of the subjects who participated in the study, our Principal Investigator, Dr. David Armstrong, all of the investigators in the trial, and the healthcare providers and clinical trial teams. Without their willingness to see this trial through to completion, we would not be in the position we are in today with data and real-world experience that illustrates the potential of SkinTE.”

About PolarityTE®

PolarityTE is focused on transforming the lives of patients by discovering, designing, and developing a range of regenerative tissue products and biomaterials for the fields of medicine, biomedical engineering and material sciences. Rather than manufacturing with synthetic and foreign materials within artificially engineered environments, PolarityTE manufactures products 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, the company creates an easily deployable, dynamic, and self-propagating product designed to regenerate the target tissues. PolarityTE's innovative methods are intended to promote and accelerate growth of the patient's tissues to undergo a form of effective regenerative healing. PolarityTE’s products, including SkinTE, are in the development stage, and are not approved or available for clinical use. Learn more at www.PolarityTE.com – Welcome to the Shift®.

Forward Looking Statements

Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. They are generally identified by words such as "believes," "may," "expects," "anticipates," "intend," "plan," "will," "would," "should" and similar expressions. Readers should not place undue reliance on such forward-looking statements, which are based upon the Company's beliefs and assumptions as of the date of this release. The Company's actual results could differ materially due to the impact of the COVID-19 pandemic, future clinical studies, and FDA regulatory matters, which cannot be predicted, and the risk factors and other items described in more detail in the "Risk Factors" section of the Company's Annual Reports and other filings with the SEC (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. The Company specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

POLARITYTE, the POLARITYTE logo, SKINTE, WHERE SELF REGENERATES SELF and WELCOME TO THE SHIFT are registered trademarks of PolarityTE, Inc.

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FAQ

What were the results of the PolarityTE DFU trial?

The trial showed 70% wound closure at 12 weeks for SkinTE plus SOC, compared to 34% for SOC alone.

What is the significance of the SkinTE trial results?

Results indicate a significant improvement in wound healing for patients using SkinTE, with a 5.37 times increased likelihood of closure.

How many adverse events were reported in the SkinTE trial?

A total of 148 adverse events were reported, with 66 in the SkinTE group and 82 in the SOC group.

Will the SkinTE trial data be used for FDA approval?

No, the trial will not be considered for a Biologic License Application.