FDA Grants Breakthrough Therapy Designation to SkinTE for Wagner Grade 1 Diabetic Foot Ulcers
By 12 weeks, investigators report that SkinTE facilitated significantly more wound closures compared with the standard of care.
The FDA granted breakthrough therapy designation to SkinTE for the treatment of Wagner grade 1 diabetic foot ulcers (DFUs).1
Data from a phase 2 (NCT03881254) multicenter, randomized, controlled trial supported the designation. | Image Credit: wladimir1804 | stock.adobe.com
“We are thrilled that the FDA has granted breakthrough therapy designation to SkinTE for the treatment of Wagner grade 1 diabetic foot ulcers,” Nik Sopko, chief operating officer and chief scientific officer of PolarityBio, said in a news release.1 “Our ongoing COVER DFUS II phase 3 pivotal trial evaluating the safety and efficacy of SkinTE to treat Wagner 1 DFUs is over 75% enrolled, and we anticipate final results in Q1 2026, which will help us further understand the role SkinTE can play in treating this serious condition.”
Data from a phase 2 (NCT03881254) multicenter, randomized, controlled trial supported the designation. The study was intended to collect patient outcome data on a commercially available human autologous homologous skin construct (SkinTE) with standard of care dressing compared to the standard of care dressing alone. It was designed to last 13 weeks with a 2-week screening period.1,2
Investigators split the study into 2 arms: the experimental arm and the standard of care arm. The experimental arm included the standard of care therapy, such as CAM boots or total contact casting, appropriate sharp or surgical debridement, infection management, SkinTE followed by a moisture retention dressing, soft roll, and compression wrap. The standard of care was similar but included a wound care covering with calcium alginate Fibrocol dressing instead of SkinTE.
The primary study end point included the percentage of index ulcers healed at 12 weeks, and secondary outcomes included percentage area reductions at 4 weeks, 6 weeks, 8 weeks, and 12 weeks, improvement in quality of life with Wound Quality of Life score, change in pain levels during the trial, and changes in peripheral neuropathy. An additional end point included visible graft take at each visit.2
There were 153 patients who were screened for the study, with 53 patients failing screening due to withdrawing consent, infections, not meeting inclusion criteria, and other reasons. There were 100 patients included in the study, with 11 subjects not completing the study. By 12 weeks, investigators reported that there were significantly more wound closures in the experimental group (35 of 50 patients) than in the control group (17 of 50 patients). For the secondary end point of percentage area reduction, the experimental group had a greater percentage at 80.7% compared to the control group at 26.8% over 8 weeks.1,3
The quality-of-life scores improved in both groups, with the experimental group having a mean baseline score of 1.3, reducing by 0.4 by the end of the study. For the control group, the baseline was 1.6, with reductions by 0.5 at the end of the study. For reductions in pain, there were also no significant differences between both groups, with the baseline in the experimental group being 1.1 and reducing by 0.7, and the control group had a baseline mean of 0.9 and reducing by 0.4.3
Furthermore, SkinTE treatment did not result in more adverse events than the standard of care.1
READ MORE: Diabetes Resource Center
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