Hoth Therapeutics’ HT-001 shows positive PK, safety and clinical activity

Hoth Therapeutics (HOTH) reported “positive” pharmacokinetic – or PK -, safety, and clinical activity data for HT-001, demonstrating a ~77% increase in systemic drug exposure following repeat dosing, minimal systemic absorption relative to oral formulations, a favorable safety profile with no serious adverse events, and “encouraging” reductions in symptom severity. In addition, HT-001 demonstrated “encouraging” clinical activity, with treated subjects exhibiting “meaningful” reductions in symptom severity and sustained response over the treatment period. These efficacy observations were consistent with the pharmacokinetic profile, suggesting that increased and sustained drug exposure may translate into improved clinical outcomes. In the company’s PK analysis, mean AUC-2 increased to 80.60 h*ng/mL on Day 42 from 45.61 h*ng/mL on Day 1, representing an approximate 76.7% increase in systemic exposure. Mean Cavg increased 76.8%, while mean Cmax increased 48.5% demonstrating consistent, dose-dependent increases in drug exposure. Systemic absorption was observed in a subset of subjects, consistent with topical delivery, and remained low overall, supporting a favorable systemic safety profile. No serious adverse events, no dose-limiting toxicities observed, and no treatment discontinuations due to adverse events. The company believes these data support continued clinical advancement and dose optimization.