PolarityBio Announces Interim Enrollment Achieved in SkinTE’s Phase III Pivotal Study

• Interim Analysis Anticipated at end of Q1 2025

SALT LAKE CITY, Dec. 03, 2024 (GLOBE NEWSWIRE) — PolarityBio, a clinical-stage biotechnology company developing regenerative tissue products, today announced that it has surpassed the interim enrollment target for SkinTE’s Phase III Pivotal Study in the treatment of Wagner 1 Diabetic Foot Ulcers (COVER DFUS II). The company has enrolled 65 subjects toward the target of 120 subjects for performing interim analysis on the trial’s 12-week primary endpoint.

“Our clinical operations team has done an excellent job of recruiting and activating trial sites,” said John Stetson, CEO of PolarityBio. “The pace of enrollment has significantly accelerated since the summer months, driving us past the halfway point toward the planned interim analysis anticipated in Q1 2025. This current pace is encouraging as we work to complete enrollment in the 1^st half of 2025.”

Dr. Felix Sigal, a Principal Investigator for COVER DFUS II at Dr. Sigal’s Foot & Ankle Clinic in Los Angeles, CA said, “This is my fourth SkinTE trial. I am excited that the COVER DFUS II trial has achieved 50% enrollment in such a short time. I look forward to the results of the trial and the possibility of SkinTE being available to help these patients who suffer from chronic non-healing diabetic foot ulcers.”

About PolarityBio

PolarityBio, headquartered in Salt Lake City, Utah, is a biotechnology company developing regenerative tissue products. PolarityBio’s first regenerative tissue product is SkinTE®. PolarityBio has an open investigational new drug application (IND) for SkinTE® with the U.S. Food and Drug Administration (FDA) and 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. SkinTE® is available for investigational use only. Learn more at www.PolarityBio.com.

Parker Scott
IR@polarityTE.com
801-455-1440