Hoth Therapeutics HT-001 Interim Results First-in-Class Topical Therapy Preserves Cancer Treatment While Resolving Dermatologic Side Effects

Hoth Therapeutics' HT-001 Achieves 100% Response Rate in at least one endpoint in Phase 2a Trial in PK Patients for EGFR Inhibitor-Related Skin Toxicities.

Hoth Therapeutics will host a Key Opinion Leader (KOL) event on, at 3:30PM EST to highlight recent clinical progress with HT-001, a novel topical therapeutic developed to address EGFR inhibitor-induced skin toxicities in cancer patients. This event will feature insights from derm-oncology and dermatology specialists Jonathan Hale Zippin M.D., Ph.D., and Adam Friedman M.D., F.A.A.D., who will present interim results from the ongoing Phase 2 trial and discuss how HT-001 could redefine supportive care standards for oncology patients.  Access/join the event through the following link: https://zoom.us/j/91353016981.

Phase 2a Trial Highlights (CLEER-001)

• 100% of enrolled patients in open-label cohort achieved at least one primary endpoint of clinical dermatologic improvement
• Over 65% reported reductions in pain and pruritus (itching)
• 0% required dose reduction or discontinuation of their EGFRI therapy.
• Topical therapy was well tolerated with no serious adverse events.

NEW YORK, June 24, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ:HOTH), a clinical-stage biopharmaceutical company developing targeted therapies for rare and serious inflammatory conditions, today announced that its investigational candidate HT-001 met the primary efficacy endpoint in at least one metric in 100% of patients in its ongoing Phase 2a clinical study (CLEER-001) evaluating treatment for epidermal growth factor receptor inhibitor (EGFRI)-induced cutaneous toxicities.

EGFR inhibitors, used widely to treat non-small cell lung cancer (NSCLC), pancreatic, breast, colorectal, and head and neck cancers, are associated with dermatologic side effects in up to 90% of patients, often resulting in painful rashes, pruritus, dryness, nail changes, and alopecia. These adverse events frequently force dose reductions or treatment discontinuation, limiting therapeutic efficacy and patient outcomes.

"HT-001 is a breakthrough candidate with the potential to be the first FDA-approved therapy specifically targeting these EGFRI-related skin toxicities," said Robb Knie, CEO of Hoth Therapeutics. "The ability to preserve full-dose cancer treatment while improving patient quality of life addresses a critical unmet need across oncology."

Phase 2a Trial Highlights (CLEER-001)

• 100% of enrolled patients in open-label cohort achieved at least one primary endpoint of clinical dermatologic improvement
• Over 65% reported reductions in pain and pruritus (itching)
• 0% required dose reduction or discontinuation of their EGFRI therapy.
• Topical therapy was well tolerated with no serious adverse events.

HT-001 is a once-daily topical gel formulated with an FDA-approved neurokinin-1 receptor antagonist (NK1RA). This mechanism mitigates inflammatory pathways triggered by EGFR inhibition, particularly Substance P-driven responses that lead to skin breakdown. By targeting the neuroinflammatory axis, HT-001 reduces symptoms without immunosuppression or systemic toxicity.

Supporting Preclinical Data

In preclinical rat models co-treated with erlotinib (5.85 mg/kg/day), HT-001 significantly reduced:

• Dermatitis and alopecia severity
• Inflammatory markers including Substance P and neutrophil activity
• Disease progression even when HT-001 was introduced after symptom onset.

Additionally, in compassionate-use human cases, complete symptom resolution was observed within one week, with no recurrence for up to three weeks post-treatment discontinuation.

Regulatory and Development Pathway

HT-001 is being advanced under the 505(b)(2) regulatory pathway, enabling the use of existing safety data to accelerate development. Key milestones include:

• IND opened and chronic toxicology completed.
• Phase 2a trial (CLEER-001) currently underway in the U.S.
• Phase 2b/3 trial planning in progress

About Hoth Therapeutics

Hoth Therapeutics, Inc. (NASDAQ:HOTH) is a biopharmaceutical company developing innovative therapies for patients with unmet medical needs. The Company's pipeline includes treatments targeting rare diseases, inflammatory skin disorders, cancer, and neurological conditions. For more information, visit: www.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: [email protected]

www.hoththerapeutics.com

Phone: (678) 570-6791

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