Hoth Therapeutics Announces Engagement with ICON and Expansion of Phase II Clinical Trial for HT-001 in Europe
Hoth Therapeutics (NASDAQ: HOTH) has announced the expansion of its Phase II clinical trial for HT-001 into European Union countries, partnering with ICON Clinical Research Limited. The trial focuses on treating skin toxicities in cancer patients associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi).
The company expects regulatory approval from three EU countries in the coming months, while continuing patient enrollment at multiple U.S. sites. This Phase 2a study aims to evaluate the efficacy, safety, and proper dosing of topical HT-001. The expansion aligns with Hoth's international clinical development strategy and sets the foundation for a future global Phase III trial.
Hoth Therapeutics (NASDAQ: HOTH) ha annunciato l'espansione della sua sperimentazione clinica di Fase II per HT-001 nei paesi dell'Unione Europea, in collaborazione con ICON Clinical Research Limited. Lo studio si concentra sul trattamento delle tossicità cutanee nei pazienti oncologici associate agli inibitori del recettore del fattore di crescita epidermico (EGFRi).
L'azienda prevede di ottenere l'approvazione regolatoria da tre paesi UE nei prossimi mesi, continuando nel contempo il reclutamento di pazienti in diversi centri negli Stati Uniti. Questo studio di Fase 2a mira a valutare l'efficacia, la sicurezza e il dosaggio appropriato di HT-001 topico. L'espansione è in linea con la strategia di sviluppo clinico internazionale di Hoth e pone le basi per un futuro trial globale di Fase III.
Hoth Therapeutics (NASDAQ: HOTH) ha anunciado la expansión de su ensayo clínico de Fase II para HT-001 en países de la Unión Europea, en asociación con ICON Clinical Research Limited. El estudio se centra en el tratamiento de toxicidades cutáneas en pacientes con cáncer asociadas a inhibidores del receptor del factor de crecimiento epidérmico (EGFRi).
La compañía espera obtener la aprobación regulatoria de tres países de la UE en los próximos meses, mientras continúa la inscripción de pacientes en varios sitios de EE. UU. Este estudio de Fase 2a tiene como objetivo evaluar la eficacia, seguridad y la dosificación adecuada de HT-001 tópico. La expansión está alineada con la estrategia internacional de desarrollo clínico de Hoth y sienta las bases para un futuro ensayo global de Fase III.
호스 테라퓨틱스(NASDAQ: HOTH)는 ICON Clinical Research Limited와 협력하여 HT-001의 2상 임상시험을 유럽 연합 국가들로 확장한다고 발표했습니다. 이 임상시험은 상피 성장 인자 수용체 억제제(EGFRi)와 관련된 암 환자의 피부 독성 치료에 중점을 두고 있습니다.
회사는 앞으로 몇 달 내에 세 개 EU 국가로부터 규제 승인을 받을 것으로 기대하며, 미국 내 여러 기관에서 환자 등록을 계속 진행하고 있습니다. 이 2a상 연구는 국소용 HT-001의 효능, 안전성 및 적절한 용량을 평가하는 것을 목표로 합니다. 이번 확장은 Hoth의 국제 임상 개발 전략과 일치하며, 향후 글로벌 3상 시험을 위한 기반을 마련합니다.
Hoth Therapeutics (NASDAQ : HOTH) a annoncé l'expansion de son essai clinique de phase II pour HT-001 dans les pays de l'Union européenne, en partenariat avec ICON Clinical Research Limited. L'étude se concentre sur le traitement des toxicités cutanées chez les patients atteints de cancer associées aux inhibiteurs du récepteur du facteur de croissance épidermique (EGFRi).
L'entreprise prévoit d'obtenir l'approbation réglementaire de trois pays de l'UE dans les mois à venir, tout en poursuivant l'inscription des patients dans plusieurs centres aux États-Unis. Cette étude de phase 2a vise à évaluer l'efficacité, la sécurité et le dosage approprié du HT-001 topique. Cette expansion s'inscrit dans la stratégie de développement clinique internationale de Hoth et prépare le terrain pour un futur essai mondial de phase III.
Hoth Therapeutics (NASDAQ: HOTH) hat die Erweiterung seiner Phase-II-Studie für HT-001 in Länder der Europäischen Union bekannt gegeben, in Zusammenarbeit mit ICON Clinical Research Limited. Die Studie konzentriert sich auf die Behandlung von Hauttoxizitäten bei Krebspatienten, die mit Inhibitoren des epidermalen Wachstumsfaktorrezeptors (EGFRi) in Verbindung stehen.
Das Unternehmen erwartet in den kommenden Monaten die behördliche Zulassung von drei EU-Ländern und setzt gleichzeitig die Patientenaufnahme an mehreren Standorten in den USA fort. Diese Phase-2a-Studie zielt darauf ab, die Wirksamkeit, Sicherheit und die richtige Dosierung von topischem HT-001 zu bewerten. Die Erweiterung entspricht Hoths internationaler klinischer Entwicklungsstrategie und bildet die Grundlage für eine zukünftige globale Phase-III-Studie.
- Strategic expansion of clinical trial into EU markets enhances patient recruitment potential
- Partnership with experienced clinical research organization ICON strengthens trial management
- Dual benefit: accelerates Phase II enrollment while preparing for global Phase III trial
- Multiple trial sites across US and EU demonstrate growing clinical presence
- Additional regulatory approvals still pending from EU countries
- Timeline for completing Phase II enrollment not specified
- No efficacy or safety data reported from current trial sites
The Company plans to extend its Phase II trial of HT-001 in Cancer Patients with skin toxicities in European Union (EU) Countries
Additional regulatory approval for the Phase II clinical trial is expected from potentially three EU countries in the upcoming months. The EU approval is part of the Company's international clinical development strategy for HT-001. The trial is currently enrolling patients in multiple sites in
"We are delighted with the addition of clinical sites in the EU and for a strong partnership with ICON. ICON was selected based on their previous clinical trial management experience and their interest in novel therapies," said Robb Knie, CEO of Hoth Therapeutics. "Broadening the clinical presence in the EU serves dual purposes. First, it addresses the near-term objective of completing enrollment of the Phase II trial. Additionally, the initiation of sites in the EU establishes the groundwork for realizing our long-term goal of conducting a global Phase III trial."
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
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