Hoth Therapeutics Launches VA-Backed Study of Novel GDNF Weight Loss Therapy Targeting Obesity and Fatty Liver Disease

Rhea-AI Summary

Hoth Therapeutics (NASDAQ: HOTH) announced a VA-backed research program to evaluate glial cell line–derived neurotrophic factor (GDNF) as a potential first-in-class biologic for obesity and nonalcoholic fatty liver disease (NAFLD).

The study, led by Dr. Srinivasan at the Atlanta VA Medical Center, begins diet group work in October 2025, starts GDNF and comparator dosing in December 2025, with tissue collection and analysis in January 2026 and initial results expected Q1 2026. Positive results could support IND-enabling development targeting both weight loss and hepatic steatosis through metabolic and neurotrophic mechanisms.

Positive

• VA-backed study adds external validation and credibility
• Study targets obesity and NAFLD concurrently
• Initial results expected Q1 2026, providing a clear near-term milestone

Negative

• Current work is pre‑IND research under Aim 1, not clinical proof
• No efficacy or clinical data available to date
• Outcome-dependent path to IND; success is not guaranteed

Insights

Translational Metabolism Analyst

VA-backed preclinical study initiated to test GDNF for obesity and fatty liver; early data due Q1 2026.

Hoth Therapeutics and the U.S. Department of Veterans Affairs have initiated a program to test glial cell line–derived neurotrophic factor (GDNF) for weight loss and hepatic steatosis. The study follows a defined Statement of Work under Aim 1 with diet groups starting in October 2025, dosing beginning in December 2025, tissue collection and analysis in January 2026, and initial results expected in Q1 2026.

The business mechanism is straightforward: demonstrate biological activity of GDNF on metabolic and neurotrophic pathways relevant to obesity and fatty liver; positive preclinical signal could support IND‑enabling activities. Key dependencies include the robustness of the preclinical model, reproducibility of weight‑loss and liver endpoints, and the ability to generate clear tissue-level biomarkers during the planned collection window.

Risks are explicit and near-term: these are early-stage experiments with milestone milestones tied to preclinical endpoints, not clinical efficacy. Outcomes may be binary for IND progression; lack of clear effects on weight or hepatic steatosis would constrain next steps. Watch the announced timeline closely—initial results in Q1 2026 and the reported dosing start in December 2025 are concrete, monitorable milestones that will determine whether the program advances to IND‑enabling studies.

Collaborative program with the U.S. Department of Veterans Affairs aims to validate GDNF as a first-in-class biologic for obesity and hepatic health.

NEW YORK, Oct. 27, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company focused on developing breakthrough therapies for metabolic, dermatologic, and inflammatory diseases, today announced the initiation of a U.S. Department of Veterans Affairs (VA)–backed study evaluating the potential of glial cell line–derived neurotrophic factor (GDNF)as a novel therapy for obesity and fatty liver disease (hepatic steatosis).

The program, led by Dr. Srinivasan and her research team at the Atlanta VA Medical Center, will explore the ability of GDNF to induce weight loss and promote resolution of fatty liver disease through metabolic and neurotrophic mechanisms. 

"We're honored to work alongside the VA on this important initiative," said Robb Knie, Chief Executive Officer of Hoth Therapeutics. "Metabolic disease and obesity continue to impact millions of people globally. By targeting both neural and metabolic pathways, GDNF could represent an entirely new class of biologic therapy for obesity and related liver conditions. We're excited about the early momentum this study brings."

Study Timeline and Objectives

The program is structured under Aim 1 of the approved Statement of Work (SOW), with key milestones as follows:

• October 2025 – Initiate high-fat and control diet groups
  
  
• December 2025 – Begin GDNF and comparator dosing
  
  
• January 2026 – Collect tissue samples and perform data analysis
  
  
• Q1 2026– Initial results expected

Positive data could support IND-enabling development of a first-in-class biologic addressing both obesity and nonalcoholic fatty liver disease (NAFLD)—representing one of the largest and fastest-growing therapeutic markets globally.

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: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791

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SOURCE Hoth Therapeutics, Inc.

FAQ

What did Hoth Therapeutics (HOTH) announce on October 27, 2025?

Hoth announced a VA-backed study evaluating GDNF as a potential biologic for obesity and fatty liver disease, starting diet groups in October 2025.

When will Hoth (HOTH) begin GDNF dosing and when are initial results expected?

GDNF and comparator dosing is scheduled to begin in December 2025, with tissue analysis in January 2026 and initial results expected in Q1 2026.

What does a VA-backed study mean for Hoth Therapeutics (HOTH) development timeline?

VA backing supports program credibility and may accelerate research milestones, with a stated near-term milestone of initial results in Q1 2026.

Could positive Hoth (HOTH) study data lead to an IND application?

Yes; the announcement says positive data could support IND-enabling development for a first-in-class GDNF biologic.

Who is leading the Hoth (HOTH) VA study and where is it conducted?

The program is led by Dr. Srinivasan and her team at the Atlanta VA Medical Center.