PolarityBio Reaches Interim Enrollment Milestone in SkinTE Phase III Study

PolarityBio, a biotechnology company working on regenerative tissue products, has announced that it has exceeded the interim enrollment goal for its Phase III Pivotal Study of SkinTE in treating Wagner 1 Diabetic Foot Ulcers (COVER DFUS II). The company has enrolled 65 participants out of the 120 needed for the interim analysis of the trial's 12-week primary endpoint.

John Stetson, CEO of PolarityBio, credited the clinical operations team for their efforts in recruiting and activating trial sites, which has led to a significant increase in the pace of enrollment since the summer months. This progress suggests that the interim analysis, anticipated for the end of Q1 2025, is on track. Stetson is optimistic that they will complete the enrollment in the first half of 2025.

Dr. Felix Sigal, a Principal Investigator for the COVER DFUS II trial at his Foot & Ankle Clinic in Los Angeles, California, expressed his enthusiasm for the trial's progress. Having been involved in four SkinTE trials, he is pleased with the rapid achievement of 50% enrollment and is eager to see the results. He hopes that SkinTE will soon be available to assist patients suffering from chronic, non-healing diabetic foot ulcers.

PolarityBio is based in Salt Lake City, Utah, and focuses on developing regenerative tissue products. SkinTE is their first product and is currently available for investigational use only. The company has an open investigational new drug application (IND) for SkinTE with the U.S. Food and Drug Administration (FDA) and is conducting pivotal studies to support a biologics license application (BLA) for treating chronic cutaneous ulcers.