PolarityTE Inc. (NASDAQ: PTE) has announced that the FDA has approved its investigational new drug submission for SkinTE evaluation for Chronic cutaneous ulcers treatment. This comes at the back of the Company’s successful resolution of clinical hold components listed by the FDA.
The approval allows the company to commence two pivotal studies
The approval allows PolarityTE to begin the first of two crucial studies planned to support its biologics licence application (BLA) for SkinTE to treat persistent cutaneous ulcers.
CEO and President Richard Hague commented, “The clearance of our IND is a critical milestone for PolarityTE and a testament to the talent and hard work of our entire team. It is important to note that our strategy to pursue a complex chronic cutaneous ulcer indication, which includes the most challenging and cost-intensive wounds, is based on the learnings from our prior commercial experience as a 361 HCT/P and from our previous non-IND DFU and VLU RCTs, which gives us a great deal of confidence as we look forward to commencing our first pivotal study in the very near future.”
PolarityTE to enroll 100 participants in COVER DFUs in the US
The first critical trial, named ” Closure Obtained with Vascularized Epithelial Regeneration for DFUs with SkinTE,” or “COVER DFUs,” is a randomized multi-center controlled trial investigating SkinTE in Wager 2 DFUs treatment. The company expects to recruit up to 100 subjects in COVER DFUs across up to 20 locations within the United States, comparing therapy with SkinTE plus standard-of-care to SoC alone. The frequency of DFUs closed after 24 weeks is the study’s primary endpoint. Secondary measures evaluated include percentage area reduction (PAR) after 4, 8, 12, 16, and 24 weeks, a better quality of life, as well as new onset of DFU infection.
Enrollment is expected to commence later in the first quarter or early in the second quarter, and the company plans to provide updates as the study continues and PolarityTE meets FDA in talks about the design and execution of the second critical study.
