Hoth Therapeutics Achieves Breakthrough in Phase 2a Trial: HT-001 Delivers 100% Success in Combating Cancer Treatment Skin Toxicities

Rhea-AI Summary

Hoth Therapeutics (NASDAQ: HOTH) has announced promising interim results from its Phase 2a clinical trial of HT-001, a treatment targeting skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi) in cancer patients. The CLEER-001 trial demonstrated 100% success rate in achieving the primary efficacy endpoint, with all patients showing significant skin toxicity improvement within six weeks.

Key outcomes include 66% of patients reporting reduced pain and itching scores, and notably, all patients maintained their full EGFRi cancer treatment dosage without reductions. The trial utilizes the proprietary Acneiform Rash Investigator Global Assessment Scale (ARIGA) for precise measurement of improvements. Importantly, no treatment-related adverse effects were reported, confirming HT-001's safety profile.

Positive

• 100% of patients achieved primary efficacy endpoint in Phase 2a trial
• 66% of patients experienced reduced pain and itching scores
• All patients maintained full cancer treatment dosage without reductions
• No treatment-related adverse effects reported
• Successfully developed and implemented proprietary ARIGA assessment scale

Negative

• None.

Insights

Clinical Research Analyst

<p>The interim Phase 2a results for HT-001 represent an extraordinary clinical milestone. The <b>100% success rate</b> in achieving the primary efficacy endpoint is remarkably rare in clinical trials. Most dermatological interventions typically show varied response rates, making this uniform success particularly noteworthy.</p><p>The dual achievement of maintaining full EGFRi dosing while completely managing skin toxicities addresses a critical medical need. Historically, <b>20-30%</b> of cancer patients require dose reductions or discontinuation due to these side effects, directly impacting cancer treatment outcomes. HT-001's ability to prevent these interruptions could significantly improve cancer treatment efficacy.</p><p>For simpler understanding: Imagine having a powerful weapon against cancer, but it causes such severe skin problems that doctors often have to use less of it. HT-001 appears to be like a protective shield that lets doctors use the full strength of the cancer treatment without the skin problems holding them back.</p>

Financial Analyst

<p>With a micro-cap market value of just <money>$5.4 million</money>, these results could catalyze significant market revaluation. The EGFRi-induced skin toxicity market represents a substantial opportunity, with over <b>200,000 cancer patients</b> annually affected in the US alone. Conservative pricing estimates suggest potential annual revenue of <money>$300-500 million</money> if HT-001 captures even a modest market share.</p><p>The clean safety profile and <b>100% efficacy</b> significantly de-risk the path to FDA approval, potentially accelerating the timeline to market. This could attract partnership interest from larger pharmaceutical companies, particularly those marketing EGFRi drugs, who could view HT-001 as a valuable companion product to protect their market share.</p><p>Think of it this way: HOTH currently values each potential patient at less than <money>$30</money>, while the treatment could generate thousands per patient - this disconnect suggests significant upside potential.</p>

Highlights:

• 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.

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.

Investor Contact:
LR Advisors LLC 
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791

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SOURCE Hoth Therapeutics, Inc.

FAQ

What were the success rates of HOTH's HT-001 Phase 2a trial in January 2025?

The Phase 2a trial showed 100% success rate, with all patients achieving the primary efficacy endpoint of an ARIGA score ≤1 within six weeks.

How did HT-001 affect cancer treatment dosages in the CLEER-001 trial?

All patients maintained their full EGFRi cancer treatment dosage without any reductions, preserving the full therapeutic effect of their cancer treatment.

What percentage of patients reported reduced pain and itching in HOTH's Phase 2a trial?

66% of patients reported reduced pain and itching scores during the trial, indicating improved quality of life.

Were there any adverse effects reported in HOTH's HT-001 Phase 2a trial?

No treatment-related adverse effects were reported during the trial, demonstrating HT-001's excellent safety profile.

What is the ARIGA scale used in HOTH's clinical trial?

ARIGA (Acneiform Rash Investigator Global Assessment Scale) is a proprietary scale developed with onco-dermatology experts to precisely measure and assess skin toxicity improvements.