HOTH News & Events

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.

Hoth Therapeutics announced positive interim results from the open-label pharmacokinetic cohort of its ongoing CLEER-001 clinical trial evaluating HT-001 in cancer patients receiving EGFR inhibitor therapy. In the open-label PK cohort, 100% of evaluable patients achieved clinical response by Week 6, accompanied by a ~50% reduction in investigator-assessed disease severity from baseline. In addition to the primary endpoint, supportive clinical endpoints showed meaningful improvements, including a ~34% improvement in oncology toxicity and a ~37% reduction in patient-reported pruritus, demonstrating both rapid onset and durability of response. Beyond the primary endpoint, HT-001 demonstrated meaningful improvements across additional clinically relevant endpoints. HT-001 was well tolerated in the open-label PK cohort, with no unexpected safety signals observed. EGFR inhibitors are cornerstone therapies across multiple major cancer indications, including lung, colorectal, and head-and-neck cancers. The CLEER-001 results highlight HT-001's potential to serve as an important oncology supportive-care therapy, helping patients remain on effective, life-extending cancer treatments.