HOTH News & Events

Hoth Therapeutics announced that the China National Intellectual Property Administration has granted Chinese Patent, titled "Targeting Kit with Splice Switching Oligonucleotides to Induce Apoptosis of Mast Cells." The patent, originally filed under PCT Application No. PCT/US2019/048400 and developed by North Carolina State University, strengthens Hoth's intellectual property portfolio and provides protection in a key global market through August 27, 2039, subject to maintenance requirements. The granted patent relates to a novel therapeutic platform utilizing splice-switching oligonucleotides designed to selectively induce apoptosis in mast cells, which play a central role in a variety of inflammatory and immunological conditions.

Hoth Therapeutics reported "positive" pharmacokinetic - or PK -, safety, and clinical activity data for HT-001, demonstrating a ~77% increase in systemic drug exposure following repeat dosing, minimal systemic absorption relative to oral formulations, a favorable safety profile with no serious adverse events, and "encouraging" reductions in symptom severity. In addition, HT-001 demonstrated "encouraging" clinical activity, with treated subjects exhibiting "meaningful" reductions in symptom severity and sustained response over the treatment period. These efficacy observations were consistent with the pharmacokinetic profile, suggesting that increased and sustained drug exposure may translate into improved clinical outcomes. In the company's PK analysis, mean AUC-2 increased to 80.60 h*ng/mL on Day 42 from 45.61 h*ng/mL on Day 1, representing an approximate 76.7% increase in systemic exposure. Mean Cavg increased 76.8%, while mean Cmax increased 48.5% demonstrating consistent, dose-dependent increases in drug exposure. Systemic absorption was observed in a subset of subjects, consistent with topical delivery, and remained low overall, supporting a favorable systemic safety profile. No serious adverse events, no dose-limiting toxicities observed, and no treatment discontinuations due to adverse events. The company believes these data support continued clinical advancement and dose optimization.

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.