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

Core Insights - Hoth Therapeutics has submitted a Clinical Trial Application (CTA) to the European Medicines Agency (EMA) to expand its ongoing Phase II trial of HT-001, a topical treatment for skin toxicities related to Epidermal Growth Factor Receptor inhibitors (EGFRi) [1][2] - This submission is a significant regulatory milestone for the company, aiming to tap into a large oncology support market that currently lacks approved treatments [2][3] - The company plans to begin patient recruitment in Europe in early 2026, complementing ongoing enrollment in the U.S. [2][6] Company Strategy - Hoth Therapeutics is focused on advancing innovative therapies to enhance patient quality of life, with a patient-centric and global development strategy [4] - The CEO emphasized the urgent need for treatments addressing skin toxicities from EGFRi therapies, highlighting the opportunity for HT-001 to improve patient outcomes and create shareholder value [3] Future Developments - The EMA's decision on the CTA is anticipated in the coming months, with plans for broader EU expansion and additional sites to accelerate patient enrollment [6] - The U.S. Phase 2a trial is progressing, evaluating the efficacy, safety, and tolerability of HT-001 [6]