Hoth Therapeutics Inc Stock Price, News & Analysis

Hoth Therapeutics (NASDAQ: HOTH) has announced positive preclinical results for HT-KIT, its antisense oligonucleotide therapy targeting KIT-driven cancers. The treatment demonstrated over 80% reduction in KIT expression in vitro and significant tumor growth inhibition in gastrointestinal stromal tumors (GIST) and mast cell tumor models.

Key achievements include successful targeting of mutant KIT mRNA transcripts with no observable off-target toxicity in liver, kidney, or bone marrow. The company plans to file an Investigational New Drug (IND) application with the FDA in early 2026, followed by Phase 1 trials. HT-KIT represents a potential alternative to current tyrosine kinase inhibitors (TKIs), addressing drug resistance concerns through its mRNA-level targeting approach.

Hoth Therapeutics (NASDAQ: HOTH) has secured a significant patent from the Japan Patent Office for its RNA-based cancer therapy targeting the KIT gene. The patent provides broad coverage for antisense oligomers designed to modify pre-mRNA splicing or reduce KIT protein expression.

The granted patent specifically covers:

• Antisense RNA molecules (10-50 nucleotides) targeting KIT pre-mRNA splicing sequences
• Morpholino and chemically modified antisense variants
• Pharmaceutical compositions and expression vectors
• Applications in both human and veterinary medicine

The KIT gene is associated with various cancers including gastrointestinal stromal tumors (GIST), leukemia, and mastocytosis. This patent strengthens Hoth's position in RNA therapeutics and provides exclusive rights to develop, partner, and commercialize ASO-based therapies targeting KIT in Japan.

Hoth Therapeutics (NASDAQ: HOTH) has reported positive interim data from the open-label portion of its Phase 2a CLEER-001 clinical trial for HT-001, a treatment targeting pruritus associated with EGFR inhibitor-induced skin toxicities in cancer patients.

The key interim results from Day 1-21 demonstrate:

• A 50% reduction in pruritus severity (mean scores decreased from 1.6 to 0.8)
• Rapid symptom improvement by Day 7 (mean score: 1.0)
• Complete pruritus resolution in some patients
• No treatment-related serious adverse events reported

The CLEER-001 study continues with both cohorts active, including the randomized, double-blind portion of the trial. The treatment aims to address quality of life issues and treatment compliance challenges faced by cancer patients using EGFR inhibitors.

Hoth Therapeutics (NASDAQ: HOTH) has partnered with Washington University School of Medicine in St. Louis on an NIH grant application to advance Alzheimer's disease research using HT-ALZ, an FDA-approved NK-1 receptor antagonist.

The research, led by Dr. Carla M. Yuede, aims to understand the mechanisms behind HT-ALZ's cognitive benefits. Preclinical studies have shown promising results:

• Significant improvement in cognitive functions
• Reduced anxiety-like behaviors
• Decreased astrocyte-driven neuroinflammation in APP/PS1 mouse models
• 15% reduction in brain interstitial fluid Aβ40 levels within 20 hours of acute treatment

The company has provided GMP-quality HT-ALZ to support the studies. If funded, the grant will investigate NK-1 receptor antagonism's cellular specificity and its potential for treating neuroinflammatory conditions.

Hoth Therapeutics (NASDAQ: HOTH) has announced promising preclinical data for its Alzheimer's treatment candidate HT-ALZ. The study revealed significant improvements in cognitive function and reduced neuroinflammation in APP/PS1 mouse models.

Key findings include:

• ~15% reduction in brain interstitial fluid Aβ levels within 20 hours
• Decreased GFAP-positive reactive astrocytes
• Improved memory and reduced anxiety-like behavior
• Enhanced sensorimotor gating without motor function impairment

HT-ALZ, an FDA-approved NK-1 receptor antagonist formulation, demonstrates a dual-action profile affecting both pathology and symptoms. The treatment is orally bioavailable, crosses the blood-brain barrier, and shows selective improvement in the presence of Alzheimer's pathology. The company plans to advance HT-ALZ into clinical development for early-stage Alzheimer's disease.

Hoth Therapeutics (NASDAQ: HOTH) has received a USPTO Filing Receipt for a new patent application covering the proprietary formulation of HT-001, its lead clinical asset. This application aims to expand the company's intellectual property portfolio, building upon their existing approved patent for the compound.

The formulation-specific filing focuses on protecting the unique composition and delivery method of HT-001, which is being developed as a topical treatment for dermatologic side effects in cancer patients undergoing EGFR inhibitor therapy. The USPTO Filing Receipt confirms the patent application's formal acceptance for examination, strengthening Hoth's IP position as they advance HT-001 through clinical development.

Hoth Therapeutics (NASDAQ: HOTH) has announced two major developments for its cancer-fighting drug candidate HT-KIT:

1. Filed amended patent claims with the USPTO for its antisense oligonucleotide (ASO) technology targeting MS4A6A and FcεRIβ genes, strengthening intellectual property protection for treating conditions like anaphylaxis, mastocytosis, and allergic asthma.

2. Initiated a GLP-compliant 4-week intravenous toxicity study in C57BL/6 mice with a 14-day recovery period, conducted in partnership with OnTargetx R&D Inc. and ITR Laboratories. The study will assess multiple dose groups, pathology, and pharmacokinetic profiling to support upcoming regulatory filings.

The company is conducting additional preclinical studies to validate HT-KIT's efficacy and safety profile, with plans to initiate regulatory discussions for first-in-human trials.