Hoth Therapeutics Inc - HOTH STOCK NEWS

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.

Hoth Therapeutics (NASDAQ: HOTH) has announced breakthrough preclinical results for HT-KIT, their novel targeted therapy for gastrointestinal stromal tumors (GIST). The study demonstrated significant efficacy in several key areas:

• Tumor cell death occurred within 24 hours of treatment
• Reduced KIT receptor expression was sustained for 72 hours
• Decreased tumor cell proliferation in GIST-T1 cells
• Significant tumor growth reduction in humanized xenograft models by day 8
• Smaller and lighter tumors in HT-KIT-treated mice compared to control group

HT-KIT targets KIT mutations, which drive GIST progression, potentially offering a new treatment option for patients who develop resistance to current therapies. The company plans to conduct additional preclinical studies before initiating regulatory discussions for first-in-human trials.

Hoth Therapeutics (NASDAQ: HOTH) has announced plans to submit an Expanded Access application for its therapeutic candidate HT-001. The drug is being developed to treat dermatological side effects in cancer patients using EGFR inhibitor treatments.

The company aims to make HT-001 available through the Expanded Access Program (EAP), also known as 'compassionate use', which allows patients with serious conditions to access investigational treatments outside traditional clinical trials. This initiative comes following positive progress in ongoing clinical studies.

The EAP submission represents a strategic move to provide treatment access while gathering additional safety and efficacy data for HT-001, specifically targeting patients who lack comparable treatment options.

Hoth Therapeutics (NASDAQ: HOTH) has announced positive results for HT-001, their topical neurokinin 1 receptor antagonist, in treating EGFR inhibitor-associated skin conditions. A case study demonstrated remarkable efficacy where a 59-year-old metastatic breast cancer patient experienced complete resolution of skin lesions after one week of twice-daily HT-001 2% cream application, with no recurrence in the following three weeks.

The therapy works by blocking the pro-inflammatory SP-NK1R pathway. The company is currently conducting a Phase 2A clinical trial to evaluate HT-001's efficacy and safety in a broader patient population with varying severities of EGFR inhibitor-induced skin reactions.

These findings will be presented at the American Academy of Dermatology (AAD) 2025 Annual Meeting from March 7-11, 2025, positioning HT-001 as a potential breakthrough therapy for EGFR inhibitor-induced dermatologic toxicities.

Hoth Therapeutics (NASDAQ: HOTH) has announced promising preclinical findings for Glial Cell Line-Derived Neurotrophic Factor (GDNF) as a potential obesity treatment. The study, using GDNF-transgenic models, demonstrated significant results in:

• Reduced body weight and fat deposition despite high-fat diet consumption
• Increased basal metabolic rate and energy expenditure
• Suppression of fat storage genes while promoting fat oxidation
• Enhanced glucose tolerance and lower serum leptin levels
• Prevention of hepatic steatosis (liver fat accumulation)

The research, conducted in partnership with the Department of Veterans Affairs, suggests GDNF could revolutionize obesity treatment by enhancing natural metabolic processes rather than restricting food intake. Hoth is exploring multiple development pathways, including recombinant protein delivery, gene therapy, and small-molecule mimetics.