The Company plans to extend its Phase II trial of HT-001 in Cancer Patients with skin toxicities in European Union (EU) Countries
NEW YORK, July 29, 2025 — Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharma innovator, today announced its engagement with ICON Clinical Research Limited (“ICON”) to expand it’s Phase II Clinical Trial for cancer patients suffering from skin toxicities associated with Epidermal Growth Factor Receptor Inhibitors (EGFRi).
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 the United States. This Phase 2a dose- ranging study to investigate the efficacy, safety, and tolerability of topical HT-001 for the treatment of skin toxicities associated with EGFRi. More information can be found at www.hoththerapeutics.com.
“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/ .