Pharma Focus America

Hoth Therapeutics Gains Protocol Approval for HT-001 Cancer Therapeutic

Thursday, July 20, 2023

Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company focused on patient care, has recently obtained approval from the Food & Drug Administration (FDA) for a protocol modification in its Phase 2a clinical trial of HT-001. The trial aims to assess the efficacy of HT-001 Gel in treating acneiform rash and other skin disorders induced by EGFRI therapy.

During the trial, participants will apply HT-001 Gel once daily for 6 weeks, and the impact on treating the mentioned skin conditions will be evaluated using various assessment tools. These tools will measure the severity of the rash, pain, itching (pruritus), and the change in the patients' quality of life.

The study will be conducted in two parts. The first part will consist of an open-label cohort, where all patients will receive the HT-001 topical gel containing the active ingredient. The second part will be a randomized, placebo-controlled, parallel Phase 2a dose-ranging study, where patients will be assigned randomly to receive one of three concentrations of HT-001 or a placebo. Hoth will compare the results of HT-001 to the placebo group during this phase to determine the treatment's efficacy.

Hoth Therapeutics' Chief Executive Officer, Robb Knie, expressed optimism about the approved protocol change, stating that it will make HT-001 more widely available to patients suffering from chemo rash due to Epidermal Growth Factor Receptor Inhibitors.

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