On March 24, 2026 Hoth Therapeutics, Inc. (NASDAQ: HOTH) reported positive pharmacokinetic (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.

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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 AUC₀–₂₄ 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 to 3.36 ng/mL from 1.90 ng/mL (~76.8%), while mean Cmax increased to 4.56 ng/mL from 3.07 ng/mL (~48.5%), demonstrating consistent, dose-dependent increases in drug exposure.

Mean and individual concentration-time profiles showed higher overall exposure at Day 42 compared to Day 1. Semilog analysis confirmed predictable elimination kinetics and sustained plasma concentrations across the dosing interval.

Importantly, systemic exposure following topical HT-001 remained minimal relative to oral formulations. On Day 1, exposure levels were approximately 0.2% of those observed with FDA-approved oral formulations, and remained below 0.5% on Day 42 despite repeated dosing.

Systemic absorption was observed in a subset of subjects, consistent with topical delivery, and remained low overall, supporting a favorable systemic safety profile.

Across paired evaluable subjects, the mean accumulation ratio (RA_AUCτ) was approximately 2.09x, with mean RA_Cmax of approximately 1.72x, supporting repeat-dose pharmacokinetic activity and sustained drug levels over time.

Safety and tolerability findings included:

No serious adverse events (0%)
No dose-limiting toxicities observed
No treatment discontinuations due to adverse events
"These pharmacokinetic results, combined with a favorable safety and tolerability profile, support the continued advancement of HT-001," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "The approximately 77% increase in systemic exposure, along with consistent accumulation and minimal systemic absorption relative to oral therapies, reinforces our dosing strategy as we advance development."

The Company believes these data support continued clinical advancement and dose optimization, with PK findings aligning with observed clinical outcomes, including meaningful reductions in symptom severity and sustained patient response.

(Press release, Hoth Therapeutics, MAR 24, 2026, View Source [SID1234663879])