On May 5, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, reported 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.
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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.
Regulatory Momentum + Clinical Validation
"Regulatory advancement paired with strong clinical signals has helped open up a new avenue for patients in Spain," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "Securing European authorization while demonstrating meaningful patient benefit reinforces our belief that HT-001 has the potential to become a critical supportive care therapy in oncology."
The Spain authorization marks an important step in Hoth’s European strategy and supports continued trial execution and expansion across additional regions.
About the CLEER Trial
The CLEER Trial (Chemotherapy Longevity by Evading EGFR Inhibitor Reactions) is a Phase 2a randomized, placebo-controlled, parallel, dose-ranging study evaluating HT-001 in patients experiencing EGFR inhibitor-related dermatologic toxicities.
About HT-001
HT-001 is a novel topical therapeutic designed to target inflammatory pathways associated with cancer therapy-induced skin toxicities, with the goal of improving tolerability and enabling uninterrupted treatment.
(Press release, Hoth Therapeutics, MAY 5, 2026, View Source [SID1234665146])