Hoth Therapeutics Secures Key European Regulatory Milestone with EMA Submission for Phase II Trial of HT-001 in Cancer Patients Suffering from EGFRi-Induced Skin Toxicities
Hoth Therapeutics (NASDAQ: HOTH) has submitted a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for its Phase II trial of HT-001, a topical treatment for skin toxicities caused by Epidermal Growth Factor Receptor inhibitors (EGFRi) in cancer patients.
The company aims to expand its ongoing Phase II trial into Europe, with patient recruitment expected to begin in early 2026. This expansion complements existing U.S. trial sites. The submission represents a significant milestone as there are currently no FDA or EMA-approved treatments for EGFRi-induced skin toxicities.
Hoth Therapeutics (NASDAQ: HOTH) ha presentato una Clinical Trial Application (CTA) all'Agenzia europea per i medicinali (EMA) per la sua sperimentazione di fase II su HT-001, un trattamento topico per le tossicità cutanee indotte dagli inibitori del recettore del fattore di crescita epidermico (EGFRi) nei pazienti oncologici.
La società intende estendere il suo attuale studio di fase II all'Europa, con l'arruolamento dei pazienti previsto per l'inizio del 2026. Questa espansione integra i siti di sperimentazione già attivi negli Stati Uniti. La sottomissione costituisce un traguardo importante, poiché al momento non esistono trattamenti approvati da FDA o EMA per le tossicità cutanee da EGFRi.
Hoth Therapeutics (NASDAQ: HOTH) ha presentado una Solicitud de Ensayo Clínico (CTA) a la Agencia Europea de Medicamentos (EMA) para su ensayo de fase II con HT-001, un tratamiento tópico para las toxicidades cutáneas causadas por inhibidores del receptor del factor de crecimiento epidérmico (EGFRi) en pacientes con cáncer.
La compañía pretende ampliar su ensayo de fase II en curso a Europa, con el reclutamiento de pacientes previsto para principios de 2026. Esta ampliación complementa los centros de ensayo ya existentes en EE. UU. La presentación representa un hito relevante, dado que actualmente no existen tratamientos aprobados por la FDA o la EMA para las toxicidades cutáneas inducidas por EGFRi.
Hoth Therapeutics (NASDAQ: HOTH)는 유럽의약품청(EMA)에 임상시험계획서(CTA)를 제출했으며, 이는 항암 환자에서 표피성장인자수용체(EGFR) 억제제(EGFRi)로 인한 피부 독성 치료를 위한 국소제제 HT-001의 2상 시험을 위한 것입니다.
회사는 진행 중인 2상 시험을 유럽으로 확대할 계획이며, 환자 모집은 2026년 초에 시작될 것으로 예상됩니다. 이번 확대는 미국의 기존 시험 기관들을 보완합니다. 현재 EGFRi로 유발되는 피부 독성에 대해 FDA나 EMA의 승인된 치료제가 없다는 점에서 이번 제출은 중요한 이정표입니다.
Hoth Therapeutics (NASDAQ: HOTH) a soumis une demande d'essai clinique (CTA) à l'Agence européenne des médicaments (EMA) pour son essai de phase II de HT-001, un traitement topique des toxicités cutanées causées par les inhibiteurs du récepteur du facteur de croissance épidermique (EGFRi) chez les patients atteints de cancer.
La société prévoit d'étendre son essai de phase II en cours à l'Europe, le recrutement des patients devant commencer début 2026. Cette expansion vient compléter les sites d'essais déjà actifs aux États-Unis. Le dépôt constitue une étape importante, car il n'existe actuellement aucun traitement approuvé par la FDA ou l'EMA pour les toxicités cutanées induites par les EGFRi.
Hoth Therapeutics (NASDAQ: HOTH) hat einen Clinical Trial Application (CTA) bei der Europäischen Arzneimittel-Agentur (EMA) für seine Phase-II-Studie zu HT-001 eingereicht, einer topischen Behandlung von Hauttoxizitäten, die durch Inhibitoren des epidermalen Wachstumsfaktor-Rezeptors (EGFRi) bei Krebspatienten verursacht werden.
Das Unternehmen beabsichtigt, seine laufende Phase-II-Studie auf Europa auszudehnen; die Patientenrekrutierung soll Anfang 2026 beginnen. Diese Erweiterung ergänzt die bestehenden Studienzentren in den USA. Die Einreichung stellt einen bedeutenden Meilenstein dar, da derzeit keine von FDA oder EMA zugelassenen Behandlungen für durch EGFRi verursachte Hauttoxizitäten existieren.
- Expansion into European market through EMA submission broadens potential market reach
- First-mover advantage with no currently approved treatments for EGFRi-induced skin toxicities
- Multiple active trial sites in U.S. with planned expansion to three EU countries
- EMA approval pending with several months wait time
- European patient recruitment not starting until early 2026
- Phase II trial still ongoing with no efficacy data reported yet
The submission marks a major regulatory inflection point for Hoth, reinforcing its commitment to a global clinical strategy and unlocking the potential to address a vast oncology support market with no currently approved treatments. Pending EMA review and approval, the Company expects to initiate European patient recruitment in early 2026, complementing active enrollment already underway at multiple
CEO Commentary
"We are very pleased with the timely CTA submission to the EMA, a pivotal step in advancing our international development of HT-001," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "Skin toxicities from EGFRi therapies remain an urgent, unmet medical need, and with no FDA or EMA-approved treatment available, advancing HT-001 in
Next Catalysts on Horizon
- EMA Decision Expected in Coming Months covering initial sites across three EU countries.
- Broader EU Expansion underway, with additional sites targeted to accelerate patient enrollment.
U.S. Phase 2a Trial Progressing – evaluating efficacy, safety, and tolerability of HT-001.
More details on the study are available at http://www.hoththerapeutics.com.
About Hoth Therapeutics, Inc.
Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to advancing innovative, first-in-class therapies designed to improve patient quality of life. With a patient-centric approach and global development strategy, Hoth is actively pursuing breakthroughs in oncology supportive care and beyond. Learn more at 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 is the purpose of Hoth Therapeutics' (NASDAQ: HOTH) HT-001 drug?
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