PolarityTE Inc. (PTE) stock prices were up 4.84% as of the market opening on July 28th, 2021, bringing the price per share up to USD$0.85 early on in the trading day.
SkinTE Clinical Trial
July 28th, 2021 saw the company announce the final data from its multi-center, randomized, and controlled trial, designed to evaluate the treatment of Diabetic Foot Ulcers. PTE stock’s proprietary investigational product SkinTE, in combination with standard of care, was evaluated against just standard of care alone.
PTE Stock’s Trial’s Success
PTE stock reported having successfully met the primary endpoint of the trial of wound closure by the twelfth week of treatment. The secondary endpoint of Percent Area Reduction (PAR) was also met, having been assesses for every even-numbered week from the fourth to the twelfth. The trial had a total enrolment of 100 participants that were split into two equal groups, with one received SOC plus SkinTE, whereas the other cohort received only SOC. The trial was conducted and evaluated across 13 different sites.
Trial Results
35 out of the 50 patients, representing 70% of the cohort, who received SkinTE in conjunction with SOC exhibited wound closure at 12 weeks. This is comparable to the 17 patients out of 50, representing 34%, exhibiting wound closure by week 12 with SOC only. 45 out of the 50 patients who received the SkinTE plus SOC treatment received a single application of SkinTE. Treatment with SkinTE in tandem with SOC resulted in an increase in the odds of would closure by a massive 5.37 times versus SOC alone.
Adverse Event Reports
The trial reported 148 Adverse events that were attributable to 49 subjects. The SkinTE plus SOC treatment cohort reported 66 AEs among 21 subjects while the SOC treatment group reported 82 Adverse Events, attributable to 28 subjects. Of this total, 26 incidents were Serious Adverse Events, with 12 occurring in the SkinTE plus standard of care across 7 subjects. 14 Serious Adverse Events were reported for the standard of care cohort, allocated across a total of 9 subjects.
Future Outlook for PTE Stock
Armed with the resounding success of the results of its SkinTE clinical trial, PTE Stock is poised to capitalize on the opportunities for the proliferation of the treatment. The company is keen to allocate resources towards consolidating and expanding its market footprint. Current and potential investors are hopeful that management will be able to leverage the resources at its disposal to facilitate significant and sustained increases in shareholder value.
