Hoth Therapeutics reports results from ongoing HT-001 program

Hoth Therapeutics (HOTH) announced positive clinical results from its ongoing HT-001 program, including achievement of the primary efficacy endpoint in interim analysis, with patients reaching an ARIGA rash severity score of less than or equal to1 by week six. In addition to the strong results in Ariga score, HT-001 demonstrated strong patient benefit across multiple clinically meaningful measures. Over 65% of patients reported meaningful reductions in pain and itching, supporting HT-001’s potential to significantly improve quality of life for patients suffering from dermatologic toxicities, including those associated with epidermal growth factor receptor inhibitor cancer therapies. Importantly, zero patients required dose reduction or discontinuation of their EGFR inhibitor therapy while receiving HT-001, highlighting the potential for HT-001 to manage dermatologic side effects without interfering with life-saving cancer treatments. HT-001 was also well tolerated, with no treatment discontinuations reported. Pharmacokinetic analysis further demonstrated that HT-001 achieves approximately 99% lower systemic exposure compared to FDA-approved oral therapies, supporting a targeted delivery profile designed to maximize local efficacy while minimizing systemic side effects. Building on these positive results, Hoth has received regulatory approval in Hungary, enabling expansion of the Phase 2 clinical trial into Europe. The Company anticipates additional regulatory approvals in Spain and Poland, with site activations expected in the near term. In the United States, an additional clinical site is expected to be activated, further accelerating patient enrollment and data generation.