Hoth Therapeutics Reports Positive Preclinical Safety Data for Cancer Fighting HT-KIT -- Dose-Dependent Liver Activity with No Observed Toxicity Supports IND Pathway
- Clear dose-dependent biological response demonstrated through liver weight increase
- 100% clean safety profile with no observable toxicity across all tested organs
- No adverse effects or visible lesions in any treated animal
- Results support advancement to GLP toxicology studies and IND submission
- Early-stage preclinical data - still requires completion of GLP studies and IND approval
- Limited to safety data only - efficacy in cancer treatment not yet demonstrated
Insights
Hoth's HT-KIT shows promising preclinical safety with dose-dependent liver engagement and zero toxicity, advancing toward IND filing.
The preclinical data for Hoth's oncology candidate HT-KIT demonstrates two critical elements that investors should understand: dose-dependent biological response and clean safety profile. The observed liver weight increase (from
From a drug development perspective, these findings represent a meaningful de-risking event. Many oncology candidates fail due to toxicity issues that emerge during development. The absence of gross pathology or visible lesions across all treatment groups positions HT-KIT well for the upcoming GLP (Good Laboratory Practice) toxicology studies, which are more rigorous and required for FDA submission. The c-KIT pathway that HT-KIT targets is implicated in multiple cancer types including gastrointestinal stromal tumors, melanoma, and certain leukemias, making this a potentially versatile therapeutic approach if successful in further development.
While these results are encouraging, it's important to contextualize that this remains early-stage data. The company must still complete formal GLP toxicology studies, submit an IND application, and receive FDA clearance before entering human clinical trials - each representing significant regulatory hurdles that many candidates fail to overcome.
HOTH ALERT: Hoth Therapeutics Reports Positive Preclinical Safety Data for HT-KIT — Dose-Dependent Activity, No Toxicity, IND on Deck
HOTH announces strong preclinical data for HT-KIT showing dose-dependent liver activity with zero observed toxicity – key milestone as the company prepares for IND filing.
Study Results:
- Liver weight increased from 1.11g → 1.32g across 0 → 3.0 mg/kg
- No adverse effects on kidney, spleen, or thymus
100% clean safety profile — no visible lesions or gross pathology- Validates safety of HT-KIT in vivo
Robb Knie, CEO: "These results strengthen our confidence in HT-KIT as we advance toward clinical trials. A strong safety signal with dose responsiveness and no toxicity gives us a clear path forward."
The study demonstrated a clear dose-responsive effect on liver mass with no observable toxicity or organ pathology, reinforcing the favorable safety profile of HT-KIT as the Company prepares for further toxicology studies and regulatory advancement.
Key Preclinical Findings (HT-KIT):
- Liver weight increased from 1.11g at 0 mg/kg to 1.32g at 3.0 mg/kg, consistent with pharmacological engagement.
- Kidney and spleen weights remained stable, indicating no off-target or systemic toxicity.
- Thymus and other critical organ weights were within normal range across all groups.
- No gross pathology or visible lesions observed in any treated animal.
"These clean and compelling safety results validate our confidence in HT-KIT," said Robb Knie, CEO of Hoth Therapeutics. "A dose-dependent biological signal without organ damage strongly supports our plan to move forward with GLP studies and an IND submission."
Hoth Therapeutics expects to initiate GLP toxicology studies, with plans to submit an Investigational New Drug (IND) application soon after.
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 any 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: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791
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SOURCE Hoth Therapeutics, Inc.
FAQ
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