Hoth Therapeutics announces Expanded Access Program aplication for HT-001

Hoth Therapeutics (HOTH) announced a major milestone in the development of its lead asset, HT-001, with the engagement of Premier Research to support submission of an Expanded Access Program, or EAP, application. This move positions Hoth to offer compassionate access to HT-001 for cancer patients suffering from painful and debilitating skin toxicities caused by epidermal growth factor receptor, or 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 of 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.