NEW YORK, July 22, 2025 — Hoth Therapeutics, Inc. (NASDAQ: HOTH), a clinical-stage biopharma innovator, today announced a CRADA (Cooperative Research and Development Agreement) with the U.S. Department of Veterans Affairs and Foundation for Atlanta Veterans Education and Research (FAVER) to evaluate GDNF (glial cell-derived neurotrophic factor) as a novel metabolic therapy targeting obesity and hepatic steatosis (fatty liver disease).
The study, conducted at the Atlanta VA Medical Center, will benchmark daily GDNF injections against semaglutide in both standard diet-induced obese mice and human liver chimeric mouse models, a gold-standard translational platform.
Dual-Arm Study: Head-to-Head vs. Semaglutide
CRADA Title:
“Efficacy of Parenteral GDNF Administration in the Induction of Weight Loss and Resolution of Hepatic Steatosis”
Study Highlights:
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Arm 1: Western diet-fed CF-1 mice treated with GDNF vs. placebo and semaglutide — tracking weight loss, liver histology, and metabolic markers.
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Arm 2: GDNF administered to TK-NOG human hepatocyte-engrafted mice — assessing human liver-specific gene expression, pathology, and glucose metabolism.
All protocols are IRB-approved and comply with VA and federal research ethics standards.
Deal Structure & Value
Under the agreement:
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Hoth Therapeutics will fund the study
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Hoth will supply GDNF while the VA retains data rights and shares de-identified results per HIPAA-compliant CRADA terms.
Key Collaborators:
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Hoth Therapeutics, Inc.
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U.S. Department of Veterans Affairs
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Foundation for Atlanta Veterans Education and Research (FAVER)
Why It Matters: Scientific Rationale
GDNF has demonstrated the ability to:
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Reduce body weight and hepatic lipid accumulation in prior transgenic models
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Enhance insulin sensitivity and promote fatty acid oxidation
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Show clinical safety in previous human trials (Parkinson’s disease)
This CRADA marks the first pharmacologic test of GDNF in human liver-engrafted mice — setting the stage for potential first-in-class metabolic applications beyond CNS indications.
“This landmark agreement allows a real-world, controlled comparison of GDNF’s metabolic effects alongside semaglutide — the current gold standard,” said Robb Knie, CEO of Hoth Therapeutics. “We are proud to support the VA’s efforts in exploring bold new solutions for obesity and liver disease.”
Learn more: 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/.