Hoth Therapeutics Achieves EU Regulatory Approval for HT-001 Clinical Program
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 15 2026
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Hoth Therapeutics has achieved a major European regulatory milestone for its HT-001 clinical program targeting cancer patients undergoing EGFR inhibitor therapies. The company received a positive regulatory conclusion under the European Union Clinical Trials Information System, or CTIS, for Part I. This determination confirms the scientific and regulatory acceptability of the trial design and investigational products. Hoth expects to activate clinical trial sites and initiate the study across multiple European countries. In parallel, country-specific Part II regulatory decisions in Hungary, Spain, and Poland are expected by January 19. The HT-001 program is being developed to address EGFRI-induced dermatologic toxicities, a common and often dose-limiting complication experienced by cancer patients undergoing treatment.
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Analyst Views on HOTH
About HOTH
Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing new generation therapies for unmet medical needs. The Company is focused on developing a topical formulation for treating side effects from drugs used for the treatment of cancer (HT-001); a treatment for mast-cell derived cancers and anaphylaxis (HT-KIT), and a treatment and/or prevention for Alzheimer's or other neuroinflammatory diseases (HT-ALZ). The Company also has assets being developed for atopic dermatitis (also known as eczema) (BioLexa); a treatment for asthma and allergies using inhalational administration (HT-004), and a treatment for obesity, and obesity-related diseases and conditions (HT-VA).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Hoth Therapeutics Reports Significant Clinical Results from HT-001 Trial in Cancer Patients
- Clinical Response Rate: In the open-label PK cohort of the CLEER-001 trial, 100% of evaluable patients achieved a clinical response by Week 6, demonstrating the efficacy of HT-001 in cancer patients and potentially laying the groundwork for future treatment options.
- Disease Severity Improvement: There was approximately a 50% reduction in disease severity (ARIGA score) from baseline, with all evaluable patients reaching ARIGA ≤1 by Week 6, indicating significant and durable treatment effects that enhance the company's competitive position in oncology.
- Reduction in Side Effects: Supportive clinical endpoints showed a ~34% improvement in oncology toxicity (CTCAE) and a ~37% reduction in patient-reported pruritus, highlighting a broad and consistent treatment effect across multiple clinically relevant measures, which may improve patient quality of life.
- Market Performance Analysis: Hoth Therapeutics' stock is currently trading at $1.075, 2.7% below its 20-day simple moving average, indicating a bearish trend in the short term, although analysts maintain a 'Buy' rating with a price target of $6.50, reflecting confidence in the company's future potential.
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Hoth Therapeutics Reports 50% Improvement in Cancer Patients with HT-001 in CLEER-001 Trial
- Primary Endpoint Improvement: In the CLEER-001 trial's open-label PK cohort, HT-001 reduced ARIGA scores from a baseline of 1.67 to 0.83, representing a ~50% improvement in disease severity, with all evaluable patients achieving low-severity status by Week 6, demonstrating rapid onset and durability of response.
- Oncology Toxicity Reduction: HT-001 showed significant improvements in additional endpoints, with a ~34% reduction in oncology toxicity (CTCAE) and a ~37% decrease in patient-reported pruritus, indicating a broad and consistent treatment effect across multiple clinically relevant measures.
- Favorable Tolerability: HT-001 was well tolerated in the open-label PK cohort, with no unexpected safety signals observed, supporting the efficacy of the selected dosing regimen and continued clinical development.
- Potential Supportive Care: The results highlight HT-001's potential as an important oncology supportive-care therapy, aiding patients in maintaining effective cancer treatments and improving their quality of life amidst the challenges posed by EGFR inhibitors.
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