Hoth Therapeutics Reports Positive Interim Results from CLEER-001 Trial
Hoth Therapeutics announced positive interim results from the open-label pharmacokinetic cohort of its ongoing CLEER-001 clinical trial evaluating HT-001 in cancer patients receiving EGFR inhibitor therapy. In the open-label PK cohort, 100% of evaluable patients achieved clinical response by Week 6, accompanied by a ~50% reduction in investigator-assessed disease severity from baseline. In addition to the primary endpoint, supportive clinical endpoints showed meaningful improvements, including a ~34% improvement in oncology toxicity and a ~37% reduction in patient-reported pruritus, demonstrating both rapid onset and durability of response. Beyond the primary endpoint, HT-001 demonstrated meaningful improvements across additional clinically relevant endpoints. HT-001 was well tolerated in the open-label PK cohort, with no unexpected safety signals observed. EGFR inhibitors are cornerstone therapies across multiple major cancer indications, including lung, colorectal, and head-and-neck cancers. The CLEER-001 results highlight HT-001's potential to serve as an important oncology supportive-care therapy, helping patients remain on effective, life-extending cancer treatments.
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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.
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.
