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Hoth Therapeutics Reports Positive HT-001 PK, Safety, and Clinical Activity Data in Cancer Patients with EGFR Therapy-Associated Skin Toxicities Showing ~77% Increase in Drug Exposure and Minimal Systemic Absorption
PK studies of topical HT-001 reveal limited systemic absorption and ~99% reduced systemic levels as compared to FDA approved oral formulations.Safety and
About this update from Hoth Therapeutics, Inc.
[{"type":"text","content":"PK studies of topical HT-001 reveal limited systemic absorption and ~99% reduced systemic levels as compared to FDA approved oral formulations.Safety and tolerability findings included:No serious adverse events (0%)No dose-limiting toxicities observed.No treatment discontinuations due to adverse eventsDay 42 Data Show Higher AUC, Cavg, and Cmax vs Day 1, with ~2.1x Accumulation Supporting Sustained Drug Exposure, Consistent Tolerability, and Clinically Meaningful ResponseNEW YORK, March 24, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH) today 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.\n \n \n \n \n \n \n \nIn 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 accumulatio...