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Hoth Therapeutics Announces Extension of Washington University Alzheimer's Mouse Model Study with Alzheimer's Therapeutic HT-ALZ

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Hoth Therapeutics, Inc. (NASDAQ: HOTH) announced an extension of its Sponsored Research Agreement with Washington University in St. Louis to further investigate HT-ALZ, a potential treatment for Alzheimer's disease. The ongoing research aims to establish a human equivalent dose for HT-ALZ, based on previous studies showing its ability to reduce amyloid β (Aβ) levels in mouse models. The study is led by Dr. Carla Yuede and Dr. John Cirrito, focusing on the effects of chronic administration on cognitive outcomes in Alzheimer’s models.

Positive
  • Extension of research agreement with Washington University to advance HT-ALZ development.
  • Initial studies indicate HT-ALZ significantly reduces Aβ levels, suggesting potential efficacy as an Alzheimer's treatment.
  • Ongoing studies aim to optimize dosing and assess cognitive improvements in mouse models before human trials.
Negative
  • None.

The focus of the new studies is to determine a human equivalent dose of HT-ALZ for starting human clinical trials

NEW YORK, June 9, 2022 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced that it has entered into an extension of its Sponsored Research Agreement with Washington University in St. Louis to support the continued research and development of HT-ALZ, a novel therapeutic for the treatment of Alzheimer's disease.

The research will continue to be led by Carla Yuede, PhD, Associate Professor of Psychiatry, and John Cirrito, PhD, Associate Professor of Neurology, at Washington University School of Medicine. Based on the data generated from the first set of Alzheimer mouse model studies, Hoth plans to continue investigating the effects of HT-ALZ on behavioral and pathological markers of Alzheimer's disease. The goal of these additional studies is to determine if HT-ALZ can improve learning and memory in an APP/PS1 mouse model of Alzheimer's disease after chronic administration prior to performing behavioral tests. The chronic dosing studies will also include a broad range of HT-ALZ doses to determine if there are dose-dependent effects on behavioral outcomes. The outcome of these studies is to estimate a human equivalent dose for initiating clinical trials for HT-ALZ.

AD is a neurodegenerative disease that is characterized by aggregates of amyloid β (Aβ) plaques and neurofibrillary tangles of Tau protein in the brain, which contribute to the clinical symptoms of the disease such as dementia. The initial experiments, conducted by Carla Yuede, PhD, Associate Professor of Psychiatry, and John Cirrito, PhD, Associate Professor of Neurology, at Washington University School of Medicine, focused on investigating the effect of orally administered HT-ALZ to reduce the concentration of Aβ in the brain interstitial fluid, using an established Alzheimer's Disease mouse model (aged APP/PS1+/- mice). The initial data from these studies showed a significant decrease in Aβ in both male and female APP/PS1+/- mice after acute treatment with HT-ALZ, compared to placebo-treated animals and baseline Aβ levels, supporting that HT-ALZ has the potential to modify Aβ plaque formation in the brain and be developed as an AD therapeutic.

About Hoth Therapeutics, Inc.
Hoth Therapeutics is a clinical-stage biopharmaceutical company dedicated to develop 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 promising 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 medications 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 Hoth may develop, and the labeling under any approval Hoth may obtain; the timing and costs of clinical trials; the timing and costs of other expenses; market acceptance of Hoth's products; the ultimate impact of the current Coronavirus pandemic, or any other health epidemic, on Hoth's business, its clinical trials, its research programs, healthcare systems or the global economy as a whole; Hoth's intellectual property; Hoth's reliance on third party organizations; Hoth's competitive position; Hoth's industry environment; Hoth's anticipated financial and operating results, including anticipated sources of revenues; Hoth's assumptions regarding the size of the available market, benefits of Hoth's products, product pricing and timing of product launches; management's expectation with respect to future acquisitions; statements regarding Hoth's goals, intentions, plans and expectations, including the introduction of new products and markets; and Hoth's 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 undue 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 Hoth believes that the expectations reflected in the forward-looking statements are reasonable, Hoth 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 entitled "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 of this press release. Consequently, forward-looking statements should be regarded solely as Hoth's current plans, estimates, and beliefs. Hoth cannot guarantee future results, events, levels of activity, performance or achievements. Hoth does not undertake and specifically declines any obligation to update 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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SOURCE Hoth Therapeutics, Inc.

FAQ

What is HT-ALZ and its significance for Alzheimer's treatment?

HT-ALZ is a novel therapeutic being developed by Hoth Therapeutics aimed at treating Alzheimer's disease, showing promise in reducing amyloid β levels in mouse models.

What does the extension of the research agreement with Washington University mean for Hoth Therapeutics?

The extension allows Hoth Therapeutics to continue critical studies on HT-ALZ, enhancing its development pipeline and potential for clinical trials.

What were the results of the initial studies on HT-ALZ?

Initial studies demonstrated that HT-ALZ significantly decreased amyloid β concentrations in treated mice compared to placebo, indicating potential therapeutic efficacy.

When does Hoth Therapeutics plan to start human clinical trials for HT-ALZ?

The ongoing studies aim to determine a human equivalent dose for HT-ALZ, which will inform the timeline for initiating human clinical trials.

Hoth Therapeutics, Inc.

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