Rocket One’s Hoth unit halts trial early, eyes phase 3 study

HOBOKEN, N.J. - Rocket One Inc. has halted its Phase 2a clinical trial of HT-001 early, according to a recent press release. HT-001 is a topical formulation of aprepitant being developed to treat skin toxicities caused by epidermal growth factor receptor (EGFR) inhibitor cancer therapies. The skin complications can cause discomfort and disrupt cancer treatment.

The interim efficacy and safety data from the trial have convinced Hoth Therapeutics, Hoth's biotechnology subsidiary, to conclude the trial and initiate discussions with the FDA regarding the next stage of HT-001's development. CEO Robb Knie expressed optimism about the interim findings, stating they support moving forward with a potential Phase 3 program.

However, it's important to note that the interim results are preliminary and could change as more data is collected and finalized. The company plans to complete the remaining data review and analysis necessary for a regulatory submission. The FDA feedback will be crucial in determining whether a Phase 3 trial will be initiated, depending on the regulatory feedback and completion of required development activities.

HT-001, which delivers aprepitant directly to affected skin, is still in the investigational stage and has not received FDA approval for any indication.