The FDA has signed off PolarityTE Inc's (NASDAQ:PTE) investigational new drug (IND) application to evaluate SkinTE to treat chronic cutaneous ulcers.
- This follows the Company satisfactorily addressing clinical hold items that the FDA had previously identified.
- The approval enables PolarityTE to commence the first of two expected pivotal studies needed to support a biologics license application (BLA) seeking a chronic cutaneous ulcer indication for SkinTE.
- Related: PolarityTE Stock Drops On FDA Clinical Hold On SkinTE Trial Application.
- The first planned pivotal study is a multi-center, randomized controlled trial evaluating SkinTE for Wager 2 diabetic foot ulcers (DFUs).
- The Company plans to enroll up to 100 patients to compare treatment with SkinTE plus the standard-of-care to the standard-of-care alone.
- Related content: Benzinga's Full FDA Calendar.
- The Company expects enrollment to begin later in Q1 or early Q2.
- Price Action: PTE shares are down 8.31% at $0.66 during the market session on the last check Tuesday.