Hoth Therapeutics Inc. (HOTH) on Thursday said it received clearance from the U.S. FDA to incorporate various changes in protocol for the ongoing HT-001 clinical trial. Following the news, the shares gained 6% in the pre-market trading.
The trial aims to evaluate the potential, effectiveness, safety, and tolerance of HT-001 as a treatment for cancer patients who experience skin toxicities due to the use of Epidermal Growth Factor Receptor Inhibitors (EGFRI).
The study is set to involve adult individuals aged 18 and above who are undergoing EGFRI therapy. There will be two separate groups in the study: Part 1 will include 12 patients in an open-label cohort to assess the pharmacokinetics of HT 001 gel, while Part 2 will be a randomized study comparing three different strengths of HT-001 gel with a placebo.
The objective of the study is to determine the most effective dose(s) for future exploration.
In the pre-market activity, HOTH is up 6.25%, to $0.08 on the Nasdaq.
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