Hoth Therapeutics Announces Positive Pre Clinical Data HT-ALZ Shows Promising Breakthrough in Alzheimer's Disease Research Acute treatment with HT-ALZ led to a rapid (~15%) reduction in brain interstitial fluid Aβ levels, within 20 hours
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) ha annunciato dati preclinici promettenti per il suo candidato al trattamento dell'Alzheimer HT-ALZ. Lo studio ha rivelato significativi miglioramenti nella funzione cognitiva e una riduzione della neuroinfiammazione nei modelli murini APP/PS1.
I risultati chiave includono:
- Riduzione di circa il 15% dei livelli di Aβ nel fluido interstiziale cerebrale entro 20 ore
- Decremento degli astrociti reattivi positivi per GFAP
- Miglioramento della memoria e riduzione del comportamento ansioso
- Potenziamento del gating sensori-motorio senza compromissione della funzione motoria
HT-ALZ, una formulazione di antagonista del recettore NK-1 approvata dalla FDA, dimostra un profilo d'azione duplice che influisce sia sulla patologia che sui sintomi. Il trattamento è bio disponibile per via orale, attraversa la barriera ematoencefalica e mostra un miglioramento selettivo in presenza di patologia di Alzheimer. L'azienda prevede di avanzare HT-ALZ nello sviluppo clinico per la malattia di Alzheimer in fase iniziale.
Hoth Therapeutics (NASDAQ: HOTH) ha anunciado datos preclínicos prometedores para su candidato a tratamiento de Alzheimer HT-ALZ. El estudio reveló mejoras significativas en la función cognitiva y una reducción de la neuroinflamación en modelos de ratón APP/PS1.
Los hallazgos clave incluyen:
- Reducción de aproximadamente el 15% en los niveles de Aβ en el líquido intersticial cerebral en 20 horas
- Disminución de astrocitos reactivos positivos para GFAP
- Mejora de la memoria y reducción del comportamiento similar a la ansiedad
- Mejoramiento del filtrado sensoriomotor sin deterioro de la función motora
HT-ALZ, una formulación de antagonista del receptor NK-1 aprobada por la FDA, demuestra un perfil de acción dual que afecta tanto la patología como los síntomas. El tratamiento es bio disponible por vía oral, cruza la barrera hematoencefálica y muestra una mejora selectiva en presencia de patología de Alzheimer. La empresa planea avanzar HT-ALZ en el desarrollo clínico para la enfermedad de Alzheimer en etapas tempranas.
Hoth Therapeutics (NASDAQ: HOTH)는 알츠하이머 치료 후보 HT-ALZ에 대한 유망한 전임상 데이터를 발표했습니다. 이 연구는 APP/PS1 생쥐 모델에서 인지 기능의 유의미한 개선과 신경 염증의 감소를 보여주었습니다.
주요 발견 사항은 다음과 같습니다:
- 20시간 이내에 뇌 간질액 Aβ 수치 약 15% 감소
- GFAP 양성 반응성 별아교세포 감소
- 기억력 향상 및 불안 유사 행동 감소
- 운동 기능 손상 없이 감각 운동 게이팅 향상
HT-ALZ는 FDA 승인된 NK-1 수용체 길항제 제형으로, 병리와 증상 모두에 영향을 미치는 이중 작용 프로파일을 보여줍니다. 이 치료법은 경구 생체이용 가능하며, 혈액-뇌 장벽을 통과하고 알츠하이머 병리의 존재에서 선택적인 개선을 나타냅니다. 이 회사는 초기 단계의 알츠하이머병에 대한 임상 개발로 HT-ALZ를 진행할 계획입니다.
Hoth Therapeutics (NASDAQ: HOTH) a annoncé des données précliniques prometteuses pour son candidat au traitement de la maladie d'Alzheimer HT-ALZ. L'étude a révélé des améliorations significatives de la fonction cognitive et une réduction de la neuroinflammation dans des modèles murins APP/PS1.
Les principales conclusions comprennent :
- Réduction d'environ 15 % des niveaux de Aβ dans le liquide interstitiel cérébral en 20 heures
- Diminution des astrocytes réactifs positifs pour GFAP
- Amélioration de la mémoire et réduction du comportement similaire à l'anxiété
- Amélioration du filtrage sensorimoteur sans altération de la fonction motrice
HT-ALZ, une formulation d'antagoniste du récepteur NK-1 approuvée par la FDA, démontre un profil d'action dual affectant à la fois la pathologie et les symptômes. Le traitement est biodisponible par voie orale, traverse la barrière hémato-encéphalique et montre une amélioration sélective en présence de pathologie d'Alzheimer. L'entreprise prévoit de faire avancer HT-ALZ dans le développement clinique pour la maladie d'Alzheimer à un stade précoce.
Hoth Therapeutics (NASDAQ: HOTH) hat vielversprechende präklinische Daten für seinen Alzheimer-Behandlungskandidaten HT-ALZ bekannt gegeben. Die Studie zeigte signifikante Verbesserungen der kognitiven Funktion und eine reduzierte Neuroinflammation in APP/PS1-Mausmodellen.
Wichtige Ergebnisse umfassen:
- ~15%ige Reduktion der Aβ-Spiegel in der interstitiellen Flüssigkeit des Gehirns innerhalb von 20 Stunden
- Verminderte GFAP-positive reaktive Astrozyten
- Verbesserte Gedächtnisleistung und reduzierte angstähnliches Verhalten
- Verbesserte sensorimotorische Gating ohne motorische Funktionsbeeinträchtigung
HT-ALZ, eine von der FDA genehmigte NK-1-Rezeptor-Antagonisten-Formulierung, zeigt ein duales Wirkungsprofil, das sowohl die Pathologie als auch die Symptome beeinflusst. Die Behandlung ist oral bioverfügbar, überwindet die Blut-Hirn-Schranke und zeigt eine selektive Verbesserung in Anwesenheit von Alzheimer-Pathologie. Das Unternehmen plant, HT-ALZ in die klinische Entwicklung für die frühe Alzheimer-Krankheit voranzubringen.
- Successful preclinical results showing 15% reduction in brain fluid Aβ levels
- Drug demonstrates dual-action profile targeting both symptoms and underlying pathology
- Treatment is based on FDA-approved compound, potentially expediting development process
- Drug shows selective effectiveness only in presence of Alzheimer's pathology
- Still in preclinical phase, requiring extensive clinical trials before potential approval
- Results to mouse models, human efficacy yet to be demonstrated
Insights
Hoth's preclinical data for HT-ALZ represents an interesting approach to Alzheimer's treatment with dual-action properties addressing both cognitive symptoms and underlying pathology. The
What's particularly noteworthy is the strategy of repurposing an already FDA-approved compound, which could potentially streamline the regulatory pathway. The drug's ability to cross the blood-brain barrier and oral bioavailability addresses two critical hurdles in CNS drug development. The effect on GFAP-positive reactive astrocytes targets neuroinflammation - increasingly recognized as a critical component of Alzheimer's progression beyond amyloid pathology.
However, investors should understand that preclinical success, particularly in APP/PS1 mouse models, has historically been a poor predictor of clinical outcomes in Alzheimer's disease. Numerous candidates have shown promise at this stage only to fail in human trials. While the established safety profile of the base compound offers some risk reduction, efficacy translation remains the primary challenge.
This preclinical milestone represents a significant development for Hoth, a micro-cap company with just
The approach is commercially interesting for three key reasons: First, repurposing an existing NK-1 receptor antagonist could accelerate development timelines and reduce costs. Second, the dual mechanism addressing both pathology and symptoms creates a differentiated position in a competitive landscape. Third, the oral administration route enhances commercial viability compared to injectable alternatives.
However, this remains very early-stage. Hoth faces substantial capital requirements to advance this program through clinical trials in a notoriously challenging indication. With current market cap under
Results underscore the dual-action profile of HT-ALZ—impacting both pathology and
symptomology.
HT-ALZ, a proprietary formulation of an FDA-approved NK-1 receptor antagonist, has shown significant cognitive and behavioral benefits in APP/PS1 mouse models of Alzheimer's disease. The study demonstrated that chronic oral administration of HT-ALZ led to marked improvement in memory, reduction of anxiety-like behavior, and enhanced sensorimotor gating, all without impairing motor function.
Crucially, HT-ALZ significantly decreased the number of GFAP-positive reactive astrocytes, key contributors to neuroinflammation and cognitive decline in AD. These results suggest that HT-ALZ exerts its therapeutic effect through modulation of astrocyte activity via NK-1 receptor antagonism, presenting a novel mechanism for targeting Alzheimer's-related neurodegeneration.
"Our findings highlight a powerful new therapeutic approach for Alzheimer's by targeting astrocyte-driven neuroinflammation," said Robb Knie, CEO of Hoth Therapeutics. "Unlike conventional strategies that focus solely on amyloid plaques, HT-ALZ addresses a broader range of pathological processes—including inflammation—that contribute to cognitive impairment."
In addition to chronic benefits, acute treatment with HT-ALZ led to a rapid (~
Importantly, HT-ALZ is orally bioavailable, crosses the blood-brain barrier, and has an established safety record, making it a compelling candidate for rapid clinical advancement. Preliminary studies showed no therapeutic effect in healthy wild-type mice, indicating HT-ALZ selectively improves function in the presence of Alzheimer's pathology.
"This research lays the groundwork for the development of HT-ALZ as a first-in-class, astrocyte-targeted therapy for Alzheimer's disease," said Robb Knie, CEO of Hoth Therapeutics. "With HT-ALZ, we have the potential to revolutionize how we treat neurodegenerative diseases by focusing on the critical role of neuroinflammation."
Hoth Therapeutics plans to advance HT-ALZ into clinical development to further evaluate its potential as a safe, effective treatment for early-stage Alzheimer's disease.
About Hoth Therapeutics, Inc.
Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to developing innovative, impactful, and ground-breaking treatments with a goal to improve patient quality of life. We are a catalyst in early-stage pharmaceutical research and development, elevating drugs from the bench to pre-clinical and clinical testing. Utilizing a patient-centric approach, we collaborate and partner with a team of scientists, clinicians, and key opinion leaders to seek out and investigate therapeutics that hold immense potential to create breakthroughs and diversify treatment options. To learn more, please visit https://ir.hoththerapeutics.com/ .
Forward-Looking Statement
This press release includes forward-looking statements based upon Hoth's current expectations, which may constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995 and other federal securities laws, and are subject to substantial risks, uncertainties, and assumptions. These statements concern Hoth's business strategies; the timing of regulatory submissions; the ability to obtain and maintain regulatory approval of existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; the timing and costs of clinical trials, and the timing and costs of other expenses; market acceptance of our products; the ultimate impact of the current coronavirus pandemic, or any other health epidemic, on our business, our clinical trials, our research programs, healthcare systems, or the global economy as a whole; our intellectual property; our reliance on third-party organizations; our competitive position; our industry environment; our anticipated financial and operating results, including anticipated sources of revenues; our assumptions regarding the size of the available market, benefits of our products, product pricing, and timing of product launches; management's expectation with respect to future acquisitions; statements regarding our goals, intentions, plans, and expectations, including the introduction of new products and markets; and our cash needs and financing plans. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. You should not place reliance on these forward-looking statements, which include words such as "could," "believe," "anticipate," "intend," "estimate," "expect," "may," "continue," "predict," "potential," "project" or similar terms, variations of such terms, or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Hoth may not realize its expectations, and its beliefs may not prove correct. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, market conditions and the factors described in the section titled "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 specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events, or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law.
Investor Contact:
LR Advisors LLC
Email: investorrelations@hoththerapeutics.com
www.hoththerapeutics.com
Phone: (678) 570-6791
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FAQ
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