Hoth Therapeutics receives FDA clearance for amendments in HT-001 clinical trial

Hoth Therapeutics announced that it has received FDA clearance to implement a number of protocol amendments to its ongoing clinical trial for HT-001, which is being developed as a potential treatment for cancer patients undergoing treatment of skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors, or EGFRI. The trial is being conducted under Hoth‘s open Investigational New Drug Application, or IND, for HT-001. This is a randomized, double-blind, placebo-controlled, multi-center Phase 2a dose-ranging study to evaluate the efficacy, safety, and tolerability of HT-001 for treatment of EGFRI-induced skin toxicity. The study will include adult patients receiving EGFRI therapy. The study will be conducted in 2 parallel cohorts: Part 1, an open-label cohort consisting of 12 patients to measure pharmacokinetics of HT 001 gel and Part 2, a randomized, parallel arm study comparing 3 dose strengths of HT-001 gel to placebo. Patients in the randomized cohorts will be randomly assigned to 1 of the 4 treatment arms in a 2:2:2:1 ratio. All patients in both open-label and blinded cohorts will apply the study drug once a day to each area affected with cutaneous toxicity up to 30% body surface area, or BSA, involvement, inclusive of skin, scalp, and nails.