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Topline Phase 2a Data: HT-001 Curbs Itch in Patients on EGFR Inhibitors

Patients experienced a 50% reduction in pruritus severity, with mean scores dropping from 1.6 on Day 1 to 0.8 by Day 21, according to positive interim data from the open-label part of Hoth Therapeutics, Inc.’s Phase 2a clinical trial evaluating HT-001 for the treatment of pruritus associated with skin toxicities caused by Epidermal Growth Factor Receptor (EGFR) inhibitors.

Moreover, rapid symptom relief was observed, with mean scores improving to 1.0 by Day 7, and some patients achieved complete resolution of pruritus within the 21-day period, the study showed.

EGFR inhibitors, widely used in oncology, are often associated with skin-related adverse effects, including intense itching. HT-001 is a proprietary, non-steroidal topical formulation under development for the treatment of pruritus and other inflammatory skin conditions associated with targeted cancer therapies. Designed for localized application, HT-001 aims to alleviate itching and irritation without the systemic side effects of traditional treatments.

HT-001 was well-tolerated, with no treatment-related serious adverse events reported.

“These findings support the potential of HT-001 to deliver meaningful relief for cancer patients experiencing EGFR-related pruritus,” says Robb Knie, Chief Executive Officer of Hoth Therapeutics, in a news release. “Cutaneous toxicities can significantly impact quality of life and may interfere with treatment. Our goal is to provide a safe and effective therapy that enhances patient comfort and continuity of care. This data, along with our initial results released in January, give us further belief in the promise of HT-001.”

The CLEER-001 study is ongoing, with both cohorts in effect, including the randomized, double-blind part of the trial.