US-based biopharmaceutical company Hoth Therapeutics has reported interim data from a Phase IIa trial of HT-001, a drug designed for treating pruritus associated with skin toxicities caused by epidermal growth factor receptor (EGFR) inhibitors.
The data from the first 21 days of the CLEER-001 trial indicated that subjects in the trial experienced a 50% decrease in the severity of pruritus, with mean scores decreasing from 1.6 on day one to 0.8 by day 21.
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Symptom relief was found to be rapid, with improvements to a mean score of 1.0 by day seven, while some subjects had achieved complete resolution within the 21-day timeframe.
The therapy was well-tolerated, with no treatment-related serious adverse events observed.
Both cohorts are engaged in this ongoing trial, which includes the randomised, double-blind portion.
HT-001 is a non-steroidal topical formulation intended for treating pruritus and other inflammatory skin conditions associated with targeted cancer therapies.
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By GlobalDataThe drug is designed for localised application to ease symptoms such as irritation and itching without the systemic side effects that are often seen with traditional therapies.
Hoth Therapeutics CEO Robb Knie said: “These findings support the potential of HT-001 to deliver meaningful relief for cancer patients experiencing EGFR-related pruritus.
“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, gives us further belief in the promise of HT-001.”
Based in New York, Hoth Therapeutics develops therapies to improve patients’ quality of life, specialising in early-stage pharmaceutical research and development.
Last year, the US Food and Drug Administration (FDA) granted approval for the protocol amendments for the company’s Phase IIa trial of HT-001.
The trial is being carried out under an active investigational new drug application (IND) for the therapy.
