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 events
Day 42 Data Show Higher AUC, Cavg, and Cmax vs Day 1, with ~2.1x Accumulation Supporting Sustained Drug Exposure, Consistent Tolerability, and Clinically Meaningful Response
NEW 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.
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_AUCt) 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.
About Hoth Therapeutics, Inc.
Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit https://ir.hoththerapeutics.com/.
Forward-Looking Statement
This press release includes forward-looking statements based upon Hoth's current expectations, which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties, and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, and the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; our intellectual property; our reliance on third-party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, and timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans, and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms, or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section titled "Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance, or achievements. Hoth does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.
Investor Contact:
LR Advisors LLC
Email: [email protected]
www.hoththerapeutics.com
Phone: (678) 570-6791
SOURCE Hoth Therapeutics, Inc.
