Hoth Therapeutics Announces Positive Results for HT-001 in Treating EGFR Inhibitor-Associated Papulopustular Eruptions Findings to be Presented at the American Academy of Dermatology 2025 Annual Meeting

Rhea-AI Summary

Hoth Therapeutics (NASDAQ: HOTH) has announced positive results for HT-001, their topical neurokinin 1 receptor antagonist, in treating EGFR inhibitor-associated skin conditions. A case study demonstrated remarkable efficacy where a 59-year-old metastatic breast cancer patient experienced complete resolution of skin lesions after one week of twice-daily HT-001 2% cream application, with no recurrence in the following three weeks.

The therapy works by blocking the pro-inflammatory SP-NK1R pathway. The company is currently conducting a Phase 2A clinical trial to evaluate HT-001's efficacy and safety in a broader patient population with varying severities of EGFR inhibitor-induced skin reactions.

These findings will be presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting from March 7-11, 2025, positioning HT-001 as a potential breakthrough therapy for EGFR inhibitor-induced dermatologic toxicities.

Positive

• Complete symptom resolution in case study patient within 1 week
• No recurrence of symptoms for 3 weeks post-treatment
• Advancement to Phase 2A clinical trials
• Potential breakthrough therapy status for unmet medical need

Negative

• data from single patient case study
• Early-stage clinical development - not yet market ready

The data will be presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting, which takes place March 7-11, 2025, highlighting HT-001 as a potential breakthrough therapy for EGFR inhibitor-induced dermatologic toxicities.

The recent case study will be highlighted that demonstrated the efficacy of HT-001 2% cream in a 59-year-old patient with metastatic breast cancer undergoing treatment with paclitaxel, trastuzumab, and pertuzumab. The patient developed pruritic, burning red papules on the face, scalp, and upper back, a known dermatologic side effect of EGFR inhibitors. After just one week of applying HT-001 2% cream twice daily, the patient experienced full symptom and lesion resolution, with no recurrence of lesions in the following three weeks.

NEW YORK, March 5, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, is excited to announce promising findings for its novel therapeutic candidate, HT-001, a topical neurokinin 1 receptor (NK1R) antagonist, in the treatment of Epidermal Growth Factor Receptor Inhibitor-Associated Papulopustular Eruptions (EGFRi PPEs).

The data will be presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting, which takes place March 7-11, 2025, highlighting HT-001 as a potential breakthrough therapy for EGFR inhibitor-induced dermatologic toxicities.

A recent case study demonstrated the efficacy of HT-001 2% cream in a 59-year-old patient with metastatic breast cancer undergoing treatment with paclitaxel, trastuzumab, and pertuzumab. The patient developed pruritic, burning red papules on the face, scalp, and upper back, a known dermatologic side effect of EGFR inhibitors. After just one week of applying HT-001 2% cream twice daily, the patient experienced full symptom and lesion resolution, with no recurrence of lesions in the following three weeks.

"These findings demonstrate the potential of HT-001 as a safe and effective therapy for EGFR inhibitor-associated skin toxicities," said Robb Knie, CEO at Hoth Therapeutics. "With a significant unmet need for long-term, well-tolerated treatment options, HT-001 could offer relief to cancer patients experiencing debilitating skin reactions."

HT-001 works by blocking the pro-inflammatory effects of the Substance P (SP)-NK1R pathway, a key mediator of neurogenic inflammation. Preclinical research has shown that HT-001 reduces inflammation and hair loss associated with EGFR inhibitor therapy. These latest clinical observations further support its potential role in dermatologic oncology.

Hoth Therapeutics is currently conducting a Phase 2A clinical trial to evaluate the efficacy and safety of HT-001 in a broader patient population. The trial will assess the treatment's effectiveness across varying severities of EGFRi PPEs and explore its impact on other dermatologic manifestations induced by EGFR inhibitors.

For more information about HT-001 and ongoing clinical trials, visit www.hoththerapeutics.com

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

View original content to download multimedia:https://www.prnewswire.com/news-releases/hoth-therapeutics-announces-positive-results-for-ht-001-in-treating-egfr-inhibitor-associated-papulopustular-eruptions-findings-to-be-presented-at-the-american-academy-of-dermatology-2025-annual-meeting-302393579.html

SOURCE Hoth Therapeutics, Inc.

FAQ

What are the clinical results of Hoth Therapeutics' HT-001 treatment for EGFR inhibitor skin reactions?

In a case study, HT-001 2% cream showed complete symptom resolution within one week of twice-daily application, with no recurrence for three weeks in a metastatic breast cancer patient.

How does Hoth Therapeutics' HT-001 work to treat EGFR inhibitor-associated skin conditions?

HT-001 works by blocking the pro-inflammatory effects of the Substance P (SP)-NK1R pathway, which is a key mediator of neurogenic inflammation.

What is the current development stage of HOTH's HT-001 treatment?

Hoth Therapeutics is currently conducting a Phase 2A clinical trial to evaluate HT-001's efficacy and safety across varying severities of EGFR inhibitor-induced skin reactions.

When will HOTH present the HT-001 clinical findings?

The findings will be presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting, taking place March 7-11, 2025.