Regulatory Clearance in Spain Advances Randomized, Placebo-Controlled Study; Patients Show Meaningful Reductions in EGFR-Inhibitor Skin Toxicities with No Treatment Disruptions

NEW YORK, May 5, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ:HOTH), a clinical-stage biopharmaceutical company, today announced that it has secured regulatory authorization in Spain for its Phase 2a CLEER Trial of HT-001, while concurrently reporting encouraging interim clinical results demonstrating meaningful efficacy and safety in cancer patients experiencing EGFR inhibitor-associated skin toxicities.

The authorization supports the continued advancement of Hoth's randomized, placebo-controlled, dose-ranging Phase 2a study evaluating HT-001 for the treatment of dermatologic toxicities associated with epidermal growth factor receptor (EGFR) inhibitor therapies.

Interim Clinical Results Highlight Strong Efficacy Signal

Preliminary data from the ongoing study indicate:

  • Patients achieved the primary efficacy endpoint, with rash severity reduced to clinically manageable levels (ARIGA ≤1) by Week 6
  • Over 65% of patients reported meaningful reductions in pain and itching
  • Zero patients required dose reduction or discontinuation of their underlying EGFR inhibitor cancer therapy
  • Favorable safety profile, with no treatment-limiting adverse events observed

These findings suggest that HT-001 may enable patients to remain on life-saving cancer therapies longer, addressing a major limitation of current oncology treatment regimens.