Hoth Therapeutics HT-001 Interim Results First-in-Class Topical Therapy Preserves Cancer Treatment While Resolving Dermatologic Side Effects

Core Insights - Hoth Therapeutics' investigational candidate HT-001 achieved a 100% response rate in at least one primary efficacy endpoint in its ongoing Phase 2a clinical study for EGFR inhibitor-induced skin toxicities [2][7] - The company will host a Key Opinion Leader event to discuss the interim results and potential impact of HT-001 on supportive care standards for oncology patients [1] Clinical Trial Highlights - The Phase 2a trial (CLEER-001) demonstrated that 100% of enrolled patients achieved at least one primary endpoint of clinical dermatologic improvement [7][8] - Over 65% of patients reported reductions in pain and pruritus, with 0% requiring dose reduction or discontinuation of their EGFR inhibitor therapy [7][8] - HT-001 is a once-daily topical gel that targets neuroinflammatory pathways without causing immunosuppression or systemic toxicity [4] Mechanism of Action - HT-001 is formulated with an FDA-approved neurokinin-1 receptor antagonist (NK1RA) that mitigates inflammatory pathways triggered by EGFR inhibition, particularly those driven by Substance P [4][5] - Preclinical data showed significant reductions in dermatitis and alopecia severity, as well as inflammatory markers in rat models co-treated with erlotinib [5][9] Regulatory and Development Pathway - HT-001 is being advanced under the 505(b)(2) regulatory pathway, which allows the use of existing safety data to expedite development [10] - The company is currently planning a Phase 2b/3 trial following the ongoing Phase 2a trial [13]