PolarityTE Inc PTE has announced results from a multi-center randomized controlled trial evaluating SkinTE for Venous Leg Ulcers (VLU). There were twenty-nine participants, with 14 receiving SkinTE plus standard of care (SOC) and 15 receiving SOC alone.
- 71% (10/14) of participants receiving SkinTE plus SOC had wound closure at 12 weeks versus 33% (5/15) of participants receiving SOC alone (p=0.046).
- Percent Area Reduction (PAR) assessed at 4, 6, 8, 10, and 12 weeks was significantly greater for the SkinTE plus SOC treatment group versus SOC alone.
- 93% (13/14) of SkinTE plus SOC treated participants received a single application of SkinTE.
- PolarityTE started the trial with a target enrollment of 100 patients, but decided in Q1 FY21 to suspend the trial after 29 patients were enrolled because the company believed that its resources would be better used in future clinical trials conducted under an open investigational new drug application (IND) that can be used in its eventual planned BLA submission.
- Since then, PolarityTE has received FDA approval of its IND for the proposed indication of chronic cutaneous ulcers.
- PolarityTE plans to conduct its first pivotal study under the IND in diabetic foot ulcers (DFU) and is evaluating additional wound types for its second planned pivotal study that is expected to be required for a BLA submission.
- Price Action: PTE shares are down 6.73% at $0.40 during the market session on the last check Tuesday.
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