Hoth Therapeutics Reports Positive HT-001 PK, Safety, and Clinical Activity Data in Cancer Patients with EGFR Therapy-Associated Skin Toxicities Showing ~77% Increase in Drug Exposure and Minimal Systemic Absorption Accessibility StatementSkip Navigation NEW YORK, March 24, 2026 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH) today reported positive pharmacokinetic (PK), safety, and clinical activity data for HT-001, demonstrating a ~77% increase in systemic drug exposure following repeat dosing, min ...

Core Insights - Hoth Therapeutics reported positive preclinical data indicating that HT-VA restores cholesterol levels and improves lipid metabolism in a model of metabolic dysfunction associated with obesity and MASLD [1] Group 1: Study Findings - The second phase of the study evaluated serum liver biochemistry and hepatic molecular pathways in female mice fed a western diet, showing that GDNF improved lipid metabolism biomarkers compared to controls and Semaglutide [1] - GDNF treatment restored cholesterol concentrations to levels comparable with control diet-fed mice, indicating improved lipid metabolism [1] - GDNF-treated mice maintained lower triglyceride levels, while Semaglutide increased triglycerides, demonstrating a more favorable lipid profile for GDNF [1] Group 2: Liver Function and Autophagy - Analysis showed no significant change in alkaline phosphatase (ALP) or albumin (ALB) levels across treatment groups, indicating stable liver synthetic function [1] - GDNF treatment did not increase p62 expression, while Semaglutide increased p62 levels, suggesting GDNF preserved normal cellular recycling pathways in the liver [1] Group 3: Molecular Signaling - No changes in CD36 or PPAR expression were observed in GDNF-treated mice, indicating improved metabolic biomarkers without activating lipogenic pathways [1] - Semaglutide treatment resulted in increased phosphorylation of AKT (pAKT) in liver tissue, while GDNF did not significantly alter pAKT signaling, highlighting a distinct molecular signaling profile [1] Group 4: Study Design - The study design included evaluation of serum liver biochemistry and hepatic protein expression related to lipid metabolism, autophagy, and apoptosis over four weeks of treatment with GDNF, Semaglutide, or vehicle [1]

Core Insights - Hoth Therapeutics has integrated OpenAI API to enhance the development of its orphan-designated therapy HT-KIT, aimed at treating rare KIT-driven cancers [1] - The company is progressing towards Investigational New Drug (IND) submission and Phase 1 clinical evaluation for HT-KIT, which has shown promising results in preclinical studies [1] Development Progress - HT-KIT has received Orphan Drug Designation and targets cancers driven by KIT mutations, addressing a significant unmet medical need [1] - The therapy has demonstrated rapid anti-tumor activity, with statistically significant tumor-volume reduction observed by Day 8 in xenograft models [1] - No dose-limiting toxicities have been reported in early studies, indicating favorable tolerability [1] Technical Achievements - The integration of OpenAI's API supports preclinical data analysis, molecular modeling of KIT-driven pathways, and regulatory documentation preparation for IND submission [1] - HT-KIT achieved over 80% reduction of KIT mRNA/protein in both in-vitro systems and in vivo models of systemic mastocytosis and GIST [1]

"Risk Factors" in Hoth's most recent Annual Report on Form 10-K and Hoth's other filings made with the U. S. Securities and Exchange Commission. All such statements speak only as of the date made. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Investors should not place undue reliance on forward-looking statements. Hoth cannot guarantee future results, events, levels of activity, performance, or achievements. Hoth does not undertake and sp ...

Core Insights - Hoth Therapeutics announced positive preclinical results for its HT-VA GDNF treatment, showing superior efficacy over semaglutide in weight loss, glucose control, and liver health in obesity models [1] Study Design and Results - The study was conducted at the Srinivasan Lab with support from the Veterans Administration, using CF-1 mice to model human obesity over a 12-week period [1] - GDNF reduced liver weight by 20-30% and prevented adipose tissue accumulation in female mice, outperforming semaglutide [1] - GDNF fully normalized fasting glucose levels and improved glucose response, showing broader metabolic benefits in both female and male models [1] - In female mice on a high-fat diet, GDNF reduced weight gain by 10-15%, leading to a plateau in weight, unlike semaglutide which had no significant impact [1] Market Potential - GDNF's differentiated mechanism could address limitations of current GLP-1 agonists, such as gastrointestinal side effects and muscle loss, positioning it as a potential gamechanger in the $200 billion obesity market [1] - With obesity affecting over 1 billion people globally and MASLD impacting up to 30% of adults, GDNF's multi-faceted benefits could revolutionize treatment paradigms [1] Future Plans - Hoth plans to accelerate GDNF toward IND-enabling studies, targeting clinical trials in 2027 [1] - The GDNF program is part of a robust pipeline that includes HT-001 for cancer-related skin toxicities, HT-KIT for mast cell cancers, and HT-ALZ for Alzheimer's [1]

Core Insights - Hoth Therapeutics Inc. has revealed promising preclinical data on glial cell-derived neurotrophic factor (GDNF) for obesity and metabolic-associated steatotic liver disease (MASLD), supported by the U.S. Veterans Administration [1][3] - GDNF has shown superior efficacy compared to semaglutide in key metrics such as weight stabilization, glucose tolerance, liver weight reduction, and adipose tissue control, particularly in female models [2][5] - The obesity market is valued at $200 billion, and GDNF's differentiated mechanism may address limitations of current GLP-1 agonists, potentially revolutionizing treatment paradigms for over 1 billion people affected by obesity and 30% of adults impacted by MASLD [3] Study Highlights - In female mice on a high-fat diet, GDNF reduced weight gain by 10-15%, leading to a plateau in weight during treatment, while semaglutide showed no significant impact [4] - GDNF normalized fasting glucose levels and improved glucose response, outperforming semaglutide in females, with additional benefits observed in males [5] - GDNF reduced liver weight by 20-30% and prevented adipose tissue accumulation in females, surpassing the effects of semaglutide [5] Future Directions - Future analyses will focus on liver pathology, lipid content, and gene/protein expression to further understand GDNF's mechanisms [6] - Hoth plans to accelerate GDNF towards IND-enabling studies, with clinical trials targeted for 2027 [6] - Hoth's pipeline includes other programs such as HT-001 for cancer-related skin toxicities, HT-KIT for mast cell cancers, and HT-ALZ for Alzheimer's [6] Market Reaction - Hoth Therapeutics shares increased by 1.83% to $0.87 during premarket trading [8]

Core Insights - Hoth Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer patients with significant unmet needs [1][2] - The company has received inquiries from investors regarding its exposure to digital assets, clarifying that it holds no cryptocurrency assets and its maximum exposure was $350,000 USD over the past year [1] - Hoth is actively progressing its HT-001 clinical trial and advancing its pipeline for further clinical trials in oncology and obesity [1] Company Overview - Hoth Therapeutics is dedicated to creating impactful treatments aimed at improving patient quality of life, serving as a catalyst in early-stage pharmaceutical research and development [2] - The company employs a patient-centric approach, collaborating with scientists, clinicians, and key opinion leaders to explore therapeutics with high potential for breakthroughs [2]

Core Insights - Hoth Therapeutics, Inc. announced positive interim results from the CLEER-001 clinical trial, demonstrating significant improvements in disease severity and patient-reported symptoms for cancer patients receiving EGFR inhibitor therapy [1][2][6]. Group 1: Primary Endpoint Results - The primary endpoint, assessed using the ARIGA scale, showed a ~50% reduction in disease severity, with mean ARIGA scores improving from 1.67 at baseline to 0.83 by Week 6 [3][4]. - All evaluable patients achieved ARIGA 1 by Week 6, indicating they fell within the low-severity disease range, with improvements noted as early as Week 3 [4]. Group 2: Additional Endpoints - The trial also reported a ~34% improvement in oncology toxicity (CTCAE), with scores decreasing from 2.0 at baseline to 1.33 at Week 6 [7]. - Patient-reported pruritus scores improved by ~37%, from a mean of 4.22 at baseline to 2.67 at Week 6, indicating a significant reduction in symptom severity [7]. Group 3: Treatment Context and Implications - EGFR inhibitors are critical in treating various cancers, but they often lead to treatment-related toxicity that can hinder patient outcomes [6]. - The results from CLEER-001 suggest that HT-001 could play a vital role in supportive care, helping patients maintain their cancer treatment regimens [6][8]. Group 4: Company Overview - Hoth Therapeutics is a clinical-stage biopharmaceutical company focused on developing innovative therapies aimed at improving the quality of life for cancer patients [9].

Core Viewpoint - Hoth Therapeutics has received a key patent approval in China for its HT-KIT cancer program, which targets KIT signaling pathways to induce apoptosis in cancer cells, enhancing its intellectual property position in a significant oncology market [1][2][3]. Group 1: Patent Approval and Technology - The patent, originating from a PCT international application, provides essential intellectual property protection in China, a rapidly growing oncology market [2]. - HT-KIT is designed to disrupt aberrant KIT-driven signaling implicated in multiple cancers, utilizing splice-switching and molecular targeting strategies to trigger programmed cell death [3][4]. - The newly approved patent covers systems and methods for targeting KIT to induce apoptosis, reinforcing Hoth's strategy of developing precision oncology therapeutics [4]. Group 2: Strategic Importance of China - China is a critical jurisdiction for oncology intellectual property due to its expanding biopharmaceutical market and increasing oncology drug adoption [5]. - Patent protection in China may enhance future partnering, licensing, and strategic transaction opportunities related to HT-KIT [5]. - Hoth continues to convert its international patent filings into issued assets, a key value inflection point for biotech investors [6]. Group 3: Global Oncology IP Portfolio - The HT-KIT patent adds to Hoth's expanding portfolio of oncology and immunology assets, emphasizing the company's commitment to building long-duration shareholder value through IP-driven drug development [7]. - Hoth plans to advance HT-KIT while pursuing additional regulatory, development, and strategic milestones across its pipeline [7].

Core Insights - Hoth Therapeutics has achieved a significant regulatory milestone in Europe for its HT-001 clinical program targeting cancer patients undergoing EGFR inhibitor therapies [1][2][3] - The company received a positive conclusion under the European Union Clinical Trials Information System (CTIS) for Part I, confirming the trial design and investigational products [2][3] - Hoth plans to activate clinical trial sites and initiate the study across multiple European countries, with country-specific decisions expected by January 19, 2026 [3][4] Regulatory and Clinical Development - The positive regulatory conclusion marks a critical inflection point for Hoth's oncology-focused pipeline, confirming the acceptability of their application for cancer-related indications [3][7] - The HT-001 program aims to address EGFRI-induced dermatologic toxicities, which are common complications for cancer patients and can negatively impact their quality of life [3][4] - The company anticipates rapid, multi-national clinical execution following the expected regulatory decisions in Hungary, Spain, and Poland [3][4] Operational Execution - Hoth expects to initiate patient enrollment and advance the HT-001 program into active clinical execution, representing a significant step toward validating a new supportive-care therapy for oncology patients [4][7] - The company is positioned for near-term regulatory and operational catalysts that will facilitate the progress of its clinical trials [7]