Rocket One ends Phase 2a trial for skin toxicity drug HT-001 early
Rocket One's subsidiary Hoth Therapeutics will conclude its Phase 2a clinical trial for HT-001 ahead of schedule, citing positive interim efficacy data. The company is now planning to seek FDA guidance for a Phase 3 study.
Rocket One announced it is ending the Phase 2a clinical trial for HT-001, an investigational topical treatment for dermatologic side effects caused by EGFR inhibitor cancer therapies. The decision follows an interim data review that the company claims supports advancing the asset to the next stage of development.
HT-001 utilizes aprepitant, a neurokinin-1 receptor antagonist, to manage skin rashes and toxicities that frequently force patients to interrupt their cancer treatments. By addressing these side effects, the developer aims to help patients better tolerate their prescribed oncology regimens.
CEO Robb Knie stated that the company is shifting its focus toward regulatory discussions with the U.S. Food and Drug Administration. These consultations are intended to define the framework for a potential Phase 3 trial, including safety requirements and patient population criteria. The candidate remains in the investigational stage and has not yet received regulatory approval.