PolarityBio has announced that its Phase III pivotal study, COVER DFUS II, evaluating SkinTE for the treatment of Wagner 1 Diabetic Foot Ulcers, has reached its interim enrollment target. The company has enrolled 65 subjects, exceeding the required number for an interim analysis of the trial's primary endpoint, which is assessed at 12 weeks.
Enrollment Progress and Anticipated Analysis
John Stetson, CEO of PolarityBio, noted the accelerated pace of enrollment since the summer months, attributing it to the clinical operations team's effective recruitment and activation of trial sites. The company anticipates conducting the interim analysis in Q1 2025 and expects to complete full enrollment in the first half of 2025.
Investigator Perspective
Dr. Felix Sigal, a principal investigator for the COVER DFUS II trial, expressed enthusiasm about the trial's progress, highlighting the potential of SkinTE to address chronic, non-healing diabetic foot ulcers. "I am excited that the COVER DFUS II trial has achieved 50% enrollment in such a short time," said Dr. Sigal. "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 SkinTE and PolarityBio
SkinTE is PolarityBio's lead regenerative tissue product. The company currently has an open investigational new drug application (IND) with the FDA for SkinTE and is pursuing two pivotal studies to support a biologics license application (BLA) for a chronic cutaneous ulcer indication. SkinTE is currently available for investigational use only.
Diabetic Foot Ulcers: An Unmet Need
Diabetic foot ulcers (DFUs) are a significant complication of diabetes, affecting millions worldwide. Wagner 1 DFUs are characterized by superficial ulcers without penetration to deeper tissues. Current treatments often involve wound care, offloading, and infection control, but many ulcers remain chronic and non-healing, leading to significant morbidity and potential amputation. New therapies like SkinTE offer hope for improved healing rates and patient outcomes.
