HOTH News & Events

Hoth Therapeutics announced new female-specific preclinical results from the second phase of its metabolic disease study evaluating glial cell-derived neurotrophic factor, or GDNF. The second phase of the study evaluated serum liver biochemistry and hepatic molecular pathways in female mice fed a western diet to model metabolic dysfunction associated with obesity and Metabolic Dysfunction-Associated Steatotic Liver Disease, or MASLD. Results demonstrate that GDNF improved lipid metabolism biomarkers and preserved key cellular pathways in the liver compared with western diet controls and the GLP-1 agonist Semaglutide. Female mice fed a western diet demonstrated increased serum cholesterol levels relative to control diet animals. Treatment with GDNF restored cholesterol concentrations to levels comparable with control diet-fed mice, indicating improved lipid metabolism in the diet-induced metabolic dysfunction model.

Hoth Therapeutics announced a significant expansion of its CLEER-001 Phase 2a clinical trial with the addition of Regis Clinical Research as a new enrolling site. Located in Miami, Florida, Regis joins the growing CLEER-001 investigational site network as surging patient demand outpaces capacity at existing sites - a direct reflection of the compelling early clinical results HT-001 has produced and the desperate unmet need it addresses.

Hoth Therapeutics announced that the USPTO has issued a Notice of Allowance for "Exon Skipping of FC-Epsilon-RI-Beta and MS4A6A in the Treatment of Allergic Diseases." The Notice of Allowance confirms that the USPTO has allowed all pending claims in the application, moving the patent toward formal issuance. This patent protects a novel dual-mechanism approach targeting key regulators of allergic and inflammatory responses. The allowed claims cover methods directed at: Exon skipping a critical component of the high-affinity IgE receptor pathway central to allergic disease activationless than modulation of MS4A6A, a gene associated with immune signaling and inflammatory regulation; combination therapeutic strategies designed to reduce hypersensitivity responses at a molecular level.

Hoth Therapeutics announced "compelling" preclinical data from its VA-backed study on glial cell-derived neurotrophic factor, or GDNF, as a novel treatment for obesity and metabolic-associated steatotic liver disease, or MASLD. In a head-to-head comparison, GDNF demonstrated superior efficacy over semaglutide - the active ingredient in Wegovy and Ozempic - in key metrics, including weight stabilization, glucose tolerance, liver weight reduction, and adipose tissue control-particularly in female models. This breakthrough positions GDNF as a potential gamechanger in the $200B obesity market, offering a differentiated mechanism that could address limitations of current GLP-1 agonists like gastrointestinal side effects and muscle loss. In female mice on a high-fat Western diet, GDNF attenuated weight gain by 10-15%, leading to a plateau in the final weeks of treatment-unlike semaglutide, which showed no significant impact. Researchers noted that higher doses or longer durations could amplify GDNF's effects. GDNF fully normalized fasting glucose and improved overall response to glucose challenges, outperforming semaglutide in females. Baseline improvements were also seen in males, indicating broad metabolic benefits. GDNF reduced liver weight by 20-30% and prevented adipose tissue accumulation in females, surpassing semaglutide's effects.