PolarityTE, Inc. ( PTE Quick Quote PTE - Free Report) announced that the FDA has approved its investigational new drug (“IND”) application for commencing a pivotal study to evaluate its regenerative tissue candidate, SkinTE, as a potential treatment of chronic cutaneous ulcers. The company has plans to conduct two pivotal studies on the candidate. Data from these pivotal studies will support a biologics license application (“BLA”) for SkinTE.
We note that PolarityTE had submitted the IND application to the FDA in July last year. However, the regulatory authority placed the proposed study in the IND application under clinical hold as certain Chemistry, Manufacturing, and Control (CMC) items needed to be addressed prior to proceeding with a pivotal study, including the assay to demonstrate the potency of SkinTE.
PolarityTE submitted its response, addressing the issues related to the clinical hold, to the FDA last month. Based on these responses, the FDA decided to remove the clinical hold on the proposed study.
The IND application for SkinTE pivotal study was based on data from a multi-center randomized controlled study, evaluating the candidate for treating diabetic foot ulcers (“DFU”). Data from the study showed that 70% of the patients who were treated with SkinTE plus standard of care achieved wound closure at 12 weeks compared to 34% of patients receiving standard of care alone.
Please note that the company has sold SkinTE since 2017 under an act of public health service or an enforcement discretion position stated by the FDA in a regenerative medicine policy framework. This health act or enforcement discretion allowed the sale of SkinTE without any FDA approval. Following the end of enforcement discretion in May 2021, PolarityTE stopped the sale of SkinTE and is currently focusing on the evaluation of the candidate in pivotal studies as a potential treatment for chronic cutaneous ulcers to gain proper FDA approval for the medicine.
Shares of PolarityTE were down 2.5% in after-hours trading on Jan 18. PolarityTE’s shares have declined 32.9% in the past year compared with the
industry’s decrease of 28.9%. Image Source: Zacks Investment Research
The first pivotal study will enroll up to 100 patients and compare SkinTE in combination with standard of care versus standard of care alone for incidence of DFU at week 24 as the primary endpoint.
PolarityTE will start enrollment in the first pivotal study later in the first quarter or early second quarter. Meanwhile, the company is also discussing the study design and implementation for the second pivotal study with the FDA.
Zacks Rank & Stocks to Consider
PolarityTE currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are
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