Hoth Therapeutics(US:HOTH) Prnewswireยท2025-06-11 12:28Core Viewpoint - Hoth Therapeutics is advancing its lead asset HT-001 by engaging Premier Research to support the submission of an Expanded Access Program (EAP) application, aiming to provide compassionate access to cancer patients suffering from skin toxicities caused by EGFR inhibitor therapies, addressing a significant unmet medical need [1][2][3]. Company Developments - Hoth Therapeutics has reported promising clinical benefits from HT-001 in early evaluations and is preparing to make the drug available to qualified patients outside of clinical trials through the Expanded Access initiative, which allows access to experimental treatments when no approved alternatives exist [3][4]. - The CEO of Hoth Therapeutics, Robb Knie, emphasized that the Expanded Access initiative reflects the company's commitment to patient care and enhances HT-001's clinical visibility and commercial potential [2][4]. Market Potential - There is a high unmet need in the market, with over 100,000 cancer patients annually receiving EGFR inhibitors, most of whom experience skin toxicities that currently lack targeted treatments [9]. - HT-001 targets a rapidly growing segment in oncology supportive care, positioning the company to capture attention from both the medical community and investors [4][9]. Regulatory and Strategic Positioning - The engagement in the Expanded Access program creates a faster route to commercialization for HT-001 and increases the generation of real-world data, which is crucial for future market acceptance [9]. - Hoth Therapeutics aims to establish itself as a leader in cancer supportive care with a clearly defined regulatory pathway and a fast-growing addressable market [4].