PolarityTE’s SkinTE Trial Meets Endpoints in Treatment of Venous Leg Ulcers

February 22, 2022—PolarityTE, Inc., a Salt Lake City, Utah–based biotechnology company developing regenerative tissue products, announced results from a multicenter randomized controlled trial (RCT) evaluating treatment of venous leg ulcers (VLUs) with the company’s investigational SkinTE plus standard of care (SOC) versus SOC alone.

SkinTE, which is available for investigational use only, is PolarityTE’s first regenerative tissue product. The company has an open investigational new drug (IND) application for SkinTE with the FDA. PolarityTE is now pursuing the first of two pivotal studies on SkinTE needed to support a biologics license application (BLA) for a chronic cutaneous ulcer indication.

According to the company, the RCT met the primary endpoint of wound closure at 12 weeks and secondary endpoint of percent area reduction (PAR) at 4, 6, 8, 10, and 12 weeks. The trial was composed of 29 patients evaluated at 10 sites, with 14 patients receiving SkinTE plus SOC and 15 patients receiving SOC alone.

PolarityTE reported that for the primary endpoint, the final analysis of the full data showed that 71% (10/14) of patients receiving SkinTE plus SOC had wound closure at 12 weeks versus 33% (5/15) receiving SOC alone (P = .046).

For the secondary endpoint, PAR assessed at 4, 6, 8, 10, and 12 weeks was significantly greater for the SkinTE plus SOC treatment group versus SOC alone (P = .000035).

Additionally, the company noted the following:

• 93% (13/14) of patients treated with SkinTE plus SOC received a single application of SkinTE.
• Average wound size for the SkinTE plus SOC treatment group was 5.8 cm² versus 6.3 cm² for the SOC treatment group (P = .46).
• A comparison by treatment group for wound-related variables showed that variables (eg, age, body mass index, gender, race/ethnicity, alcohol use, smoking, diabetes, creatinine) were well balanced between groups.
• The number of debridements was significantly lower for the SkinTE plus SOC treatment group compared to the SOC group.

Finally, the company reported that there were 39 adverse events allocated to 12 patients. The SkinTE plus SOC treatment group had 17 adverse events allocated to five patients versus the SOC group that had 22 adverse events allocated to seven patients. There were eight serious adverse events: four in the SkinTE plus SOC treatment group (one patient) and four in the SOC group (two patients).

PolarityTE advised that this trial was started with a target enrollment of 100 patients, but the company decided in the first quarter of 2021 to suspend the trial after 29 patients were enrolled because the company believed that its resources would be better used in future clinical trials conducted under an open IND that can be used in its eventual planned BLA submission.

PolarityTE has subsequently received FDA approval of its IND for the proposed indication of chronic cutaneous ulcers.

The company plans to conduct its first pivotal study under the IND in diabetic foot ulcers and is evaluating additional wound types—including but not limited to VLUs—for its second planned pivotal study that is expected to be required for a BLA submission, stated PolarityTE.