Hoth Therapeutics Achieves Positive EU CTIS Conclusion, Near-Term Clinical Trial for Cancer Patients Set to Initiate
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 15 2026
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Source: PRnewswire
- Regulatory Milestone: Hoth Therapeutics has achieved a positive conclusion under the EU Clinical Trials Information System for its HT-001 clinical program, confirming the scientific and regulatory acceptability of the trial design and investigational products, marking a significant advancement in the oncology sector.
- Multi-Country Trial Launch: The company expects to activate clinical trial sites and initiate the study across multiple European countries, rapidly advancing multi-national clinical execution to meet the urgent demand for new therapies among cancer patients.
- Targeted Treatment Development: The HT-001 program aims to address EGFR inhibitor-induced dermatologic toxicities, a common side effect that negatively impacts cancer patients' quality of life and increases healthcare burdens, with Hoth's new therapy poised to enhance patient treatment experiences.
- Rapid Decision Anticipation: Hoth expects to receive country-specific Part II regulatory decisions in Hungary, Spain, and Poland by January 19, 2026, thereby accelerating the overall clinical trial process and further solidifying its market position in oncology.
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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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