Hoth Therapeutics (NASDAQ:HOTH) announced Thursday that it has received a positive regulatory conclusion under the European Union Clinical Trials Information System (CTIS) for Part I of its HT-001 clinical program.
This pivotal determination confirms the scientific and regulatory acceptability of the trial's design and investigational products, marking a significant "inflection point" for the company’s oncology-focused pipeline.
The HT-001 program is a first-in-class topical gel designed to treat dermatologic toxicities—specifically painful rashes and skin breakdown—associated with Epidermal Growth Factor Receptor (EGFR) inhibitors.
These side effects affect up to 90% of patients taking such cancer therapies and often lead to dose reductions or the complete discontinuation of life-saving treatments.
With the Part I conclusion secured, Hoth now has a clear line of sight for site activation across Europe.
In parallel, the company expects country-specific Part II decisions for Hungary, Spain, and Poland by January 19, 2026.
These approvals will allow for immediate patient enrollment and the transition into active clinical execution across a multi-national network.
The Phase 2a study, known as CLEER-001, is a dose-ranging trial evaluating the efficacy and safety of HT-001.
Interim data from the U.S. portion of the trial has already shown a 100% success rate in reaching primary efficacy endpoints in the initial cohort, with 66% of patients reporting a significant reduction in pain and itching.
Crucially, all trial participants were able to maintain their full anti-cancer medication dosage.
The company is advancing HT-001 via the FDA’s 505(b)(2) regulatory pathway, which streamlines development by utilizing existing safety data from previously approved compounds.
In addition to the EU expansion, Hoth recently filed for new patents to cover HT-001's use in managing skin toxicities caused by radiation and emerging targeted therapies like menin inhibitors.