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Hoth Says HT-001 Met Efficacy Goals in Phase 2a Trial for Cancer-Linked Skin Toxicities
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Hoth Says HT-001 Met Efficacy Goals in Phase 2a Trial for Cancer-Linked Skin Toxicities
Jun 24, 2025 9:08 AM

11:51 AM EDT, 06/24/2025 (MT Newswires) -- Hoth Therapeutics ( HOTH ) said Tuesday its investigational candidate HT-001 met key efficacy goals in all patients in a phase 2a clinical trial targeting skin toxicities caused by epidermal growth factor receptor inhibitors.

The trial showed promising results, with all patients seeing clinical improvement and over 65% reporting less pain and itching; no one needed to reduce or stop cancer treatment, and the topical therapy was well tolerated.

HT-001 is a once-daily topical gel using a US Food and Drug Administration-approved neurokinin-1 receptor antagonist designed to reduce inflammation triggered by EGFRIs without immunosuppression. Preclinical and compassionate-use data also support the gel's effectiveness in mitigating symptoms like dermatitis and alopecia.

Hoth is advancing HT-001 under the FDA's 505(b)(2) pathway, using existing safety data to accelerate development, with chronic toxicology studies completed and phase 2b/3 trial planning in progress, the biopharmaceutical company said.

Shares of Hoth were up more than 2% in recent Tuesday trading.

Price: 1.26, Change: +0.03, Percent Change: +2.45

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