Hoth Therapeutics Announces Positive Findings on GDNF's Potential as a Game-Changer in Obesity Treatment and Reduced Fatty Liver Disease

• Research Demonstrates GDNF's Ability to Prevent and Reverse Obesity by Enhancing Fat Metabolism and Energy Expenditure
• Hoth is developing this therapeutic in Partnership with the Department of Veterans Affairs

Key Findings from the Study:

• Protection Against High-Fat Diet-Induced Obesity – GDNF-tg mice exhibited significantly lower body weight and reduced fat deposition despite consuming a high-fat diet.
• Enhanced Fat Burning and Energy Expenditure – GDNF increased basal metabolic rate, oxygen consumption, and carbon dioxide production, leading to higher energy expenditure without changes in food intake.
• Inhibition of Fat Cell Formation (Adipogenesis) – GDNF suppressed key genes involved in fat storage, including PPAR-γ, FASN, and SREBF1, while promoting fat oxidation pathways.
• Improved Insulin Sensitivity and Glucose Regulation – GDNF-tg mice showed enhanced glucose tolerance and lower serum leptin levels, markers of improved metabolic health.
• Reduced Fatty Liver Disease – GDNF prevented hepatic steatosis (fat accumulation in the liver), a common obesity-related complication.

NEW YORK, March 4, 2025 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharmaceutical company, today announced preclinical findings that highlight the potential of Glial Cell Line-Derived Neurotrophic Factor (GDNF) as a revolutionary treatment for obesity. The study, conducted in GDNF-transgenic (GDNF-tg) models, demonstrated that GDNF significantly reduces fat accumulation, enhances metabolism, and improves insulin sensitivity, even under high-fat diet conditions.

"These compelling findings reinforce GDNF's potential to fundamentally alter the way we approach obesity treatment," said Robb Knie CEO of Hoth Therapeutics. "Unlike traditional weight-loss interventions that primarily focus on appetite suppression or caloric restriction, GDNF directly enhances the body's natural ability to burn fat and increase metabolic efficiency."

Key Findings from the Study:

• Protection Against High-Fat Diet-Induced Obesity – GDNF-tg mice exhibited significantly lower body weight and reduced fat deposition despite consuming a high-fat diet.
• Enhanced Fat Burning and Energy Expenditure – GDNF increased basal metabolic rate, oxygen consumption, and carbon dioxide production, leading to higher energy expenditure without changes in food intake.
• Inhibition of Fat Cell Formation (Adipogenesis) – GDNF suppressed key genes involved in fat storage, including PPAR-γ, FASN, and SREBF1, while promoting fat oxidation pathways.
• Improved Insulin Sensitivity and Glucose Regulation – GDNF-tg mice showed enhanced glucose tolerance and lower serum leptin levels, markers of improved metabolic health.
• Reduced Fatty Liver Disease – GDNF prevented hepatic steatosis (fat accumulation in the liver), a common obesity-related complication.

A Paradigm Shift in Obesity Treatment

Obesity is a major global health crisis, affecting over 650 million adults worldwide and contributing to life-threatening conditions such as type 2 diabetes, cardiovascular disease, and metabolic syndrome. Current pharmacological treatments often have limited efficacy or undesirable side effects. Hoth Therapeutics' research into GDNF suggests a novel mechanism for weight management that works by enhancing energy metabolism rather than restricting food intake.

"The data suggest that GDNF-based therapies could offer an entirely new approach to obesity treatment—one that activates the body's natural metabolic processes to burn excess fat efficiently," added Robb Knie, CEO Hoth Therapeutics. "This represents a significant advancement over current anti-obesity drugs, which often fail to maintain long-term weight loss."

Next Steps in Development

Hoth Therapeutics is actively exploring multiple pathways for the clinical translation of GDNF-based therapies, including recombinant protein delivery, gene therapy, and small-molecule mimetics that can activate the same metabolic pathways. The company plans to initiate further preclinical and clinical development efforts to bring this potential therapy closer to patients in need.

For more information on Hoth Therapeutics and its innovative pipeline, please visit www.hoththerapeutics.com

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.