#United States #Atlanta #Semaglutide #Hoth Therapeutics #GDNF

Hoth Therapeutics Teams Up with VA to Explore Breakthrough Therapy

In a significant advancement for metabolic disease research, Hoth Therapeutics, Inc. (NASDAQ: HOTH), a leader in biopharmaceutical innovations, has announced a cooperative research initiative (CRADA) with the U.S. Department of Veterans Affairs and the Foundation for Atlanta Veterans Education and Research (FAVER). This landmark study will assess GDNF (glial cell-derived neurotrophic factor) as a potential treatment for both obesity and fatty liver disease.

Understanding the Study

Conducted at the Atlanta VA Medical Center, the study aims to directly compare GDNF injections to the widely-used drug semaglutide in mice models that exhibit diet-induced obesity. Researchers will utilize a dual-arm approach with two specific groups:

1. Western Diet-Fed Mice: This group will undergo treatment with GDNF against a placebo and semaglutide, focusing on metrics like weight loss, liver histology, and metabolic markers.
2. Human Liver Chimeric Mice: Here, GDNF will be administered to TK-NOG mice that have been engrafted with human hepatocytes, allowing researchers to monitor human-specific gene expression and evaluate glucose metabolism.

All research protocols are approved by the Institutional Review Board (IRB) and adhere strictly to the ethical standards of both VA and federal research regulations.

The Partnership's Framework

Under the terms of the agreement, Hoth Therapeutics will finance the entirety of the study while supplying GDNF. The VA will retain the rights to the data generated, sharing de-identified results in compliance with HIPAA regulations. This partnership brings together key collaborators:

• - Hoth Therapeutics, Inc.
• - U.S. Department of Veterans Affairs
• - Foundation for Atlanta Veterans Education and Research (FAVER)

Scientific Significance

Research indicates that GDNF has previously shown potential benefits in reducing body weight and hepatic lipid accumulation in transgenic models. It has also improved insulin sensitivity and promoted fatty acid oxidation while demonstrating clinical safety in earlier trials focused on Parkinson’s disease. This study marks the first pharmacologic evaluation of GDNF in mice models engrafted with human liver tissue, paving the way for its application in metabolic conditions beyond central nervous system indications.

Robb Knie, CEO of Hoth Therapeutics, expressed enthusiasm about the partnership, stating, "This groundbreaking agreement enables a real-world, controlled comparison of GDNF's metabolic impacts relative to semaglutide, the current standard treatment. We are honored to support the VA's mission in investigating innovative solutions for obesity and liver disease."

Towards Future Innovations

The findings from this study could be pivotal, not only for treatment of obesity and fatty liver disease but also for advancements in therapies targeting other metabolic dysfunctions. As Hoth Therapeutics continues to explore novel and effective treatments, its collaboration with the VA sets a progressive tone for the future of therapeutic options in this critical healthcare arena.

For more details about Hoth Therapeutics and its cutting-edge research, visit www.hoththerapeutics.com.