PolarityTE Announces First Subject Screened in Phase III Pivotal Study Evaluating Investigational New Drug SkinTE® in Diabetic Foot Ulcers
February 26, 2024
SALT LAKE CITY, Feb. 26, 2024 (GLOBE NEWSWIRE) — PolarityTE today announced the Screening of the first subject in the Phase III pivotal study evaluating SkinTE in the investigational treatment of Wagner grade 1 diabetic foot ulcers (DFUs), entitled “Closure Obtained with Vascularized Epithelial Regeneration for DFUs with SkinTE II,” or “COVER DFUS II.”
COVER DFUS II will enroll up to 120 subjects at up to 20 clinical sites in the United States. Subjects will be randomized to one of two treatment groups, receiving either SkinTE plus the standard of care (SOC) or the SOC alone. The primary endpoint is the incidence of DFUs closed at 12 weeks. Secondary endpoints include percent area reduction (PAR) at 4, 8, and 12 weeks; Total number of in-person wound care clinic visits and/or hospital days related to the index ulcer from Randomization Visit (RV1); Total days of CAM Boot use related to the index ulcer from Randomization Visit (RV1); Time to closure within 24 weeks; and Proportion of subjects experiencing treatment-emergent AEs between SOC and SkinTE arms.
COVER DFUS II is a pivotal study that PolarityTE will conduct under its open IND for SkinTE.
Nikolai Sopko, MD, PhD, Chief Operating and Scientific Officer, commented, “DFUs often persist because the tissues within the wound bed are biologically exhausted. We are excited to evaluate how the optimized healthy cells from the patient in SkinTE can facilitate closure in these difficult-to-treat ulcers. We are thankful for the patients and investigators whose participation makes this trial possible.”
Dr. David Armstrong, Professor of Surgery and director of the Southwestern Academic Limb Salvage Alliance (SALSA) at the Keck School of Medicine and board director of PolarityTE, commented, “Every second, someone around the world develops a diabetic foot ulcer. These patients are at immediately high risk not only for amputation but also for hospitalization and even death. This is why I’m so thrilled that we are evaluating the ability of a promising therapy that might help us stem the tide of needless suffering for our patients and their families.”
About Grander Acquisition LLC
Grander Acquisition LLC, doing business as PolarityTE and headquartered in Salt Lake City, Utah, is a biotechnology company developing regenerative tissue products, which include SkinTE. Grander Acquisition LLC has an open investigational new drug application (IND) for SkinTE® in the treatment of DFUs with the U.S. Food and Drug Administration (FDA) and is now pursuing pivotal studies needed to support a biologics license application (BLA). SkinTE is available for investigational use only. Learn more at www.PolarityTE.com.
Parker Scott
IR@polarityTE.com
801-455-1440