US-based biopharmaceutical company Hoth Therapeutics Inc (NASDAQ:HOTH) on Wednesday announced a milestone in the development of its lead asset, HT-001, with the engagement of Premier Research to support submission of an Expanded Access Program (EAP) application.

According to Hoth, this move positions the company to offer compassionate access to HT-001 for cancer patients suffering from painful and debilitating skin toxicities caused by epidermal growth factor receptor (EGFR) inhibitor therapies, an area of high unmet medical need.

HT-001 has shown promising signs of clinical benefit in early evaluations, and now Hoth is preparing to make the investigational drug available to qualified patients outside ongoing clinical trials. Expanded Access, often referred to as compassionate use, represents an important regulatory pathway that allows patients ineligible for traditional trials to gain access to experimental treatments when no approved alternatives exist.

This strategic move expands HT-001's reach in a market with no currently approved targeted treatment.