On July 29, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharma innovator, reported 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) (Press release, Hoth Therapeutics, JUL 29, 2025, View Source [SID1234654617]).

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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."