NEW YORK, United States – May 5, 2026
Hoth Therapeutics, Inc. has announced that it secured regulatory authorization in Spain for its ongoing Phase 2a CLEER Trial evaluating HT-001, while simultaneously reporting encouraging interim clinical data showing strong efficacy and safety in cancer patients suffering from EGFR inhibitor-associated skin toxicities. The authorization represents an important milestone in the company’s European expansion strategy and supports continued enrollment and execution of the randomized, placebo-controlled study. Interim results demonstrated clinically meaningful reductions in rash severity, pain, and itching, while allowing patients to continue their underlying cancer therapies without interruption. The findings position HT-001 as a potentially important supportive care treatment for oncology patients receiving epidermal growth factor receptor (EGFR) inhibitor therapies, where dermatologic toxicities remain a major challenge affecting treatment adherence and patient quality of life.
Interim Data Show Strong Clinical Benefit
According to preliminary findings from the ongoing CLEER study, patients receiving HT-001 achieved the trial’s primary efficacy endpoint, with rash severity reduced to clinically manageable levels defined as ARIGA ≤1 by Week 6. In addition, more than 65% of patients reported meaningful reductions in pain and itching, two of the most common and debilitating side effects associated with EGFR inhibitor treatments.
Importantly, no patients required dose reduction or discontinuation of their underlying cancer therapy due to skin-related adverse effects, highlighting the potential of HT-001 to improve treatment tolerability and support uninterrupted cancer care. The therapy also demonstrated a favorable safety profile, with no treatment-limiting adverse events reported during the interim analysis period. These results are particularly significant because severe dermatologic toxicities are a common reason patients reduce or discontinue highly effective EGFR-targeted cancer therapies.
Spain Authorization Expands European Development Strategy
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The newly secured regulatory authorization in Spain enables Hoth Therapeutics to continue advancing its Phase 2a CLEER Trial across Europe, supporting broader clinical development of HT-001. The CLEER study, formally known as Chemotherapy Longevity by Evading EGFR Inhibitor Reactions, is designed as a randomized, placebo-controlled, parallel, dose-ranging clinical trial evaluating the effectiveness of HT-001 in managing EGFR inhibitor-induced skin toxicities.
Hoth Therapeutics stated that the Spanish regulatory clearance strengthens its European clinical infrastructure and opens opportunities for additional regional trial expansion. CEO Robb Knie emphasized that the combination of regulatory progress and positive interim efficacy signals reinforces confidence in HT-001’s potential to become an important supportive care therapy in oncology.
HT-001 Targets a Significant Unmet Need in Oncology
EGFR inhibitors are widely used across multiple cancer types, including lung, colorectal, and head and neck cancers, but their effectiveness is often accompanied by severe skin toxicities such as rashes, irritation, itching, and inflammation. These adverse events can significantly impact patient comfort, adherence, and long-term treatment outcomes.
HT-001 was specifically developed as a novel topical therapeutic targeting inflammatory pathways associated with cancer therapy-induced dermatologic toxicities, with the goal of enabling patients to remain on life-saving cancer treatments for longer durations. By addressing one of the most common dose-limiting side effects of EGFR inhibitor therapies, HT-001 could fill a major gap in oncology supportive care, an area receiving increasing industry attention as cancer survival rates improve and treatment tolerability becomes more important.
Growing Opportunity in Oncology Supportive Care
The positive interim findings and regulatory advancement position Hoth Therapeutics within the expanding oncology supportive care market, where therapies aimed at improving quality of life and treatment adherence are becoming strategically important. Unlike traditional cancer treatments focused directly on tumor reduction, supportive care therapies seek to minimize treatment-related complications and enhance patient outcomes during long-term therapy.
If future clinical data continue to demonstrate efficacy and safety, HT-001 could emerge as a differentiated supportive care product capable of improving both patient experience and continuity of oncology treatment. The company believes the therapy has the potential to become a critical component of supportive oncology management as use of targeted EGFR therapies continues expanding globally.
Source: Hoth Therapeutics press release
