100% of Patients in Cohort 1 Achieve Primary Efficacy Endpoint
No Treatment-Related Adverse Effects Observed
Preserves Cancer Treatment Efficacy with Zero Dose Reductions
NEW YORK, Jan. 7, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a leading biopharmaceutical company focused on patient-centric solutions, today shared encouraging interim safety and efficacy results from its Phase 2a clinical trial of HT-001, designed to address skin toxicities linked to Epidermal Growth Factor Receptor Inhibitors (EGFRi) in cancer patients.
(PRNewsfoto/Hoth Therapeutics Inc.)
Exceptional Patient Outcomes:
Data from the open-label portion of the CLEER-001 trial demonstrated remarkable success:
100% of patients achieved the primary efficacy endpoint of an ARIGA score ≤1, showing significant skin toxicity improvement by the six-week mark.
66% of patients reported reduced pain and itching scores, further enhancing quality of life.
Crucially, all patients maintained their full EGFRi dosage, preserving the cancer treatment's full therapeutic effect—a notable improvement compared to past reports showing widespread dose reductions or treatment halts due to skin-related side effects.
A Groundbreaking Approach:
The trial uses the proprietary Acneiform Rash Investigator Global Assessment Scale (ARIGA), developed in collaboration with onco-dermatology experts. The innovative scale ensures precise measurement and assessment of skin toxicity improvements.
Robb Knie, CEO of Hoth Therapeutics, remarked, "These results are a significant milestone, underscoring HT-001's potential to transform patient care by mitigating debilitating skin toxicities while maintaining critical cancer treatments. Our data highlight HT-001's strong safety profile and the potential for it to set a new standard of care in this underserved area."
A Strong Safety Profile:
No treatment-related adverse effects have been reported, reaffirming HT-001's excellent tolerability.
Looking Ahead:
"These interim findings align with a recent case report of rapid resolution of EGFRi-induced skin conditions using HT-001," added Knie. "As the study progresses, we anticipate further validating these results and are excited about the potential impact HT-001 could have on patient outcomes."
Hoth Therapeutics is committed to advancing groundbreaking treatments and improving patient lives through innovative therapies like HT-001. Full results from this trial are eagerly awaited as patient enrollment continues.
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.
