Primary endpoint ARIGA improved by ~50% from baseline by Week 6, with all evaluable patients reaching low-severity disease; additional endpoints demonstrated ~34% improvement in oncology toxicity (CTCAE) and ~37% reduction in patient-reported pruritus.
NEW YORK, Jan. 22, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company focused on advancing innovative therapies for cancer patients with significant unmet needs, today announced positive interim results from the open-label pharmacokinetic (PK) 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 (CTCAE) and a ~37% reduction in patient-reported pruritus, highlighting a broad and consistent treatment effect across multiple clinically relevant measures.
Primary Endpoint: Marked Improvement in Disease Severity (ARIGA)
The primary endpoint of CLEER-001 assessed disease severity using the ARIGA scale. In the open-label PK cohort, mean ARIGA scores improved from 1.67 at baseline to 0.83 at Week 6, representing an approximate 50% reduction in severity.
Importantly, all evaluable patients reached ARIGA ≤1 by Week 6, placing the entire evaluable cohort within the low-severity disease range. Improvements were observed as early as Week 3 and were maintained through Week 6, demonstrating both rapid onset and durability of response.
Additional Endpoints: Improvement in Oncology Toxicity and Patient-Reported Symptoms
Beyond the primary endpoint, HT-001 demonstrated meaningful improvements across additional clinically relevant endpoints:
- Oncology Toxicity (CTCAE):
Investigator-assessed CTCAE scores improved from 2.0 at baseline to 1.33 at Week 6, representing an approximate 34% improvement in treatment-related toxicity. CTCAE is a core oncology toxicity scale frequently used to guide dose modification, interruption, or discontinuation of cancer therapies. - Pruritus (Patient-Reported NRS):
Mean pruritus scores improved from 4.22 at baseline to 2.67 at Week 6, representing approximate 37% reduction in symptom severity. This level of improvement exceeds commonly accepted thresholds for clinically meaningful benefit and is directly relevant to patient comfort, quality of life, and treatment adherence.
Favorable Tolerability and PK-Supported Dosing
HT-001 was well tolerated in the open-label PK cohort, with no unexpected safety signals observed. The PK portion of CLEER-001 was designed to evaluate exposure, tolerability, and early clinical signal, and the observed consistent improvements across investigator-assessed and patient-reported endpoints support the selected dosing regimen and continued clinical development.
Oncology Context and Unmet Need
EGFR inhibitors are cornerstone therapies across multiple major cancer indications, including lung, colorectal, and head-and-neck cancers. However, treatment-related toxicity and symptom burden remain among the most common and dose-limiting challenges, often impacting treatment continuity and outcomes. 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.
Management Commentary
"These results represent a meaningful milestone for HT-001," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "Seeing 100% clinical response in the open-label PK cohort, along with a ~50% reduction in disease severity and additional improvements in oncology toxicity and patient-reported symptoms, underscores the potential of HT-001 to improve the treatment experience for cancer patients receiving EGFR inhibitors. We are encouraged by the breadth and consistency of these findings as the CLEER-001 trial continues."
About HT-001
HT-001 is Hoth Therapeutics' proprietary topical therapy under investigation for the management of treatment-related toxicity and symptom burden in cancer patients receiving targeted therapies, including EGFR inhibitors.
About Hoth Therapeutics, Inc.
Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit https://ir.hoththerapeutics.com/.
Forward-Looking Statement
This press release includes forward-looking statements based upon Hoth's current expectations, which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties, and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, and the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; our intellectual property; our reliance on third-party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, and timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans, and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms, or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section titled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance, or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.
Investor Contact:
LR Advisors LLC
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791
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