January 22, 2026
Finance

Hoth Therapeutics Reports Promising Interim Results in CLEER-001 Trial Demonstrating Complete Response Rate in Cancer Patients

HT-001 Shows Rapid and Sustained Reduction in Disease Severity Among Patients on EGFR Inhibitor Therapy

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Summary

Hoth Therapeutics, Inc. disclosed encouraging interim findings from the open-label pharmacokinetic cohort of its ongoing CLEER-001 clinical trial evaluating HT-001 in patients undergoing epidermal growth factor receptor (EGFR) inhibitor cancer therapy. Every evaluable patient in this cohort experienced a clinical response within six weeks, alongside a near 50% reduction in disease severity, measured by the ARIGA scale. The treatment benefits surfaced as early as week three and sustained through week six, with additional positive signals observed in oncology toxicity and pruritus metrics.

Key Points

The open-label PK cohort of the CLEER-001 trial showed a 100% clinical response rate in evaluable cancer patients by Week 6.
Disease severity decreased by approximately 50%, with all patients achieving ARIGA scores indicating low severity within six weeks.
Rapid onset of improvement was observed as early as Week 3, with effects maintained through Week 6, including a 34% reduction in oncology toxicity and 37% reduction in patient-reported pruritus.
HT-KIT demonstrated significant tumor cell death in preclinical models within 24 hours, relevant to gastrointestinal stromal tumors and systemic mastocytosis.

Hoth Therapeutics, Inc. (NASDAQ:HOTH) announced interim clinical results from the pharmacokinetic (PK) cohort within its CLEER-001 trial, investigating HT-001 in cancer patients who are receiving treatment with epidermal growth factor receptor (EGFR) inhibitors. According to Benzinga Pro data, Hoth Therapeutics experienced a significant trading volume spike on the day of the announcement, reported at 2.199 million shares compared to the company’s average trading volume of approximately 397,070 shares. The stock has traded within a 52-week range of $0.6554 to $2.115.


Within the open-label PK cohort segment of the study, the clinical outcomes were notable. Evaluations revealed that 100% of patients who could be assessed showed a clinical response by the sixth week of treatment. This was demonstrated by an approximate 50% decrease in disease severity from baseline as rated by the ARIGA scale, a tool used for assessing severity in this patient population. All evaluable patients achieved ARIGA scores of ≤1 by week six, positioning them within a low disease severity classification.

The improvements were not only significant but also rapid, with some clinical benefits evident as early as week three. These improvements were durable, maintaining through the six-week evaluation period. Supporting endpoints in the trial further reinforced these positive results. Notably, there was a reported approximately 34% improvement in oncology-related toxicity, quantified using the Common Terminology Criteria for Adverse Events (CTCAE). In parallel, patient-reported outcomes highlighted a roughly 37% reduction in pruritus, or itching, symptoms. These findings collectively underscore a consistent and broad therapeutic effect of HT-001 across multiple clinical measures.


In addition to the clinical update, Hoth Therapeutics’ drug candidate HT-KIT was previously reported to exhibit significant anti-tumor activity in preclinical settings. As revealed in September 2025, tumor cell death was observed within 24 hours of treatment in models of gastrointestinal stromal tumors (GIST) and systemic mastocytosis, with statistically significant reductions in tumor volume noted by the eighth day post-treatment.


Stock market data reveals that Hoth Therapeutics’ shares are trading below short-term simple moving averages, with prices 2.7% beneath the 20-day SMA and 3.5% below the 50-day SMA, illustrating a near-term bearish momentum. Over the prior 12 months, shares declined by about 22.79%, trending closer to the lower end of their 52-week range. The Relative Strength Index (RSI) currently stands at 45.29, a neutral reading indicating the stock is neither overvalued nor oversold at present. Meanwhile, the Moving Average Convergence Divergence (MACD) indicator is above its signal line, suggesting some underlying bullish momentum. Together, these signals point to a mixed but cautiously optimistic sentiment regarding the company's stock in the short term.

Key technical resistance and support levels are noted at approximately $1.05 and $1.00, respectively.


Analyst coverage of Hoth Therapeutics remains generally positive. The consensus rating is Buy, with an average price target around $6.50. Specific recent analyst activity includes a maintained Buy rating and a $5.00 price target from D. Boral Capital as of December 4, 2025.


At the last market check on Thursday, Hoth Therapeutics stock rose 2.86% to $1.075 per share, reflecting investor reaction to the clinical findings. Supplemental research from a recent Benzinga report highlights several stocks of interest for the coming year, with Hoth Therapeutics featuring among names seen as promising growth opportunities based on proprietary growth, value, quality, and momentum metrics.


These interim trial results offer encouraging data on HT-001’s potential as a treatment option for managing disease severity and associated symptoms in cancer patients receiving EGFR inhibitor therapy. Continued observation of longer-term outcomes and larger patient cohorts will be critical to further evaluating the therapeutic value and safety profile of this investigational agent.

Risks
  • Shares of Hoth Therapeutics have experienced a 22.79% decline over the past year, showing recent bearish trends below key moving averages.
  • The stock currently trades near its 52-week lows, potentially reflecting challenges in clinical development or market confidence.
  • Although interim clinical data are positive, longer-term efficacy and safety remain unconfirmed pending further trial progress.
  • Stock momentum indicators show mixed signals, suggesting uncertainty in market sentiment despite recent positive trial news.
Disclosure
Education only / not financial advice
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