Hoth Therapeutics' HT-001 Hits ARIGA ≤1 by Week Six with 65% Symptom Relief and Hungary Trial Expansion
HT-001 achieved primary endpoint with patients reaching ARIGA rash severity score ≤1 by week six in interim analysis, while over 65% reported meaningful reductions in pain and itching and no EGFR inhibitor therapy interruptions. Pharmacokinetic data showed ~99% lower systemic exposure, and Hungary approved expansion of the Phase 2 trial.
1. Interim Analysis Results
In interim analysis of the Phase 2 HT-001 trial, all patients reached an ARIGA rash severity score of ≤1 by week six, meeting the primary efficacy endpoint. Over 65% of participants also reported significant reductions in pain and itching, underscoring the therapy’s potential to improve quality of life for those on EGFR inhibitor regimens.
2. Safety and Pharmacokinetics
HT-001 was well tolerated with zero dose reductions or discontinuations of concurrent EGFR inhibitor therapy. Pharmacokinetic profiling demonstrated approximately 99% lower systemic exposure than FDA-approved oral therapies, indicating a focused local delivery profile that minimizes systemic side effects.
3. Regulatory Expansion Plans
Hoth secured regulatory approval in Hungary to expand its HT-001 Phase 2 trial and expects additional nods in Spain and Poland in the near term. A new clinical site in the United States is also scheduled for activation to accelerate patient enrollment and data generation.