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Hoth Therapeutics Announces HT-ALZ Therapeutic Shows Cognitive Improvements in Alzheimer's Disease Mouse Model

Chronic treatment with HT-ALZ (>5 weeks) demonstrated significant improvement in behavioral and cognitive function tests in an Alzheimer's disease (AD) mouse model supporting a positive therapeutic potential of HT-ALZ for treatment of AD

NEW YORK, July 12, 2022 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, today announced proof-of-concept data generated using cognitive and behavioral assessments in an Alzheimer's disease mouse model (aged APP/PS1+/- mice), supporting the therapeutic cognitive potential of HT-ALZ after chronic oral dosing. The research was conducted as part of the company's Sponsored Research Agreement with Washington University in St. Louis. HT-ALZ is a therapeutic in development under the 505(b)(2) regulatory pathway for the treatment of dementia related to Alzheimer's disease (AD).

The chronic dosing experiments, conducted by Carla Yuede, PhD, Associate Professor of Psychiatry, and John Cirrito, PhD, Associate Professor of Neurology, at Washington University School of Medicine, included a battery of behavioral assessments (eg, pre-pulse inhibition, novel object recognition, cued and contextual fear conditioning) after >5 weeks oral treatment with HT-ALZ. These behavioral assessments are considered the gold standard for predictive cognitive, learning, and memory improvement potential for AD therapeutics. All of the behavioral tests performed after >5 weeks treatment showed a significant improvement in the HT-ALZ treated groups compared to the vehicle treated groups, with similar cognitive and behavioral trends in the HT-ALZ-treated groups compared to the wild type (non-AD) animals. Overall, the results support the therapeutic potential of HT-ALZ to provide cognitive improvement as an AD therapeutic.

Dr. Cirrito commented, "Chronic dosing had a significant effect on four behavioral deficits that these mice develop due to Aβ pathology. Such results provide confidence that the investigational treatment is having a meaningful impact in the brain."

Other behavioral assessments performed at earlier treatment periods (less than 5 weeks treatment) with HT-ALZ did not show a significant improvement compared to vehicle treated animals, however, were trending in a positive predictive manner towards improvement; this data suggests a time-dependent improvement after initiation of HT-ALZ treatment consistent with other AD therapeutics1. These other behavioral assessments are currently being repeated after longer HT-ALZ dosing periods (eg, 6 weeks).

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. Previously Hoth reported study results 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 shows 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. Further work is underway to determine how HT-ALZ impacts Aβ pathology following chronic treatment.

Future research studies to be conducted by Dr. Cirrito and Dr. Yuede will investigate the effect of HT-ALZ on memory, anxiety, and executive function in the APP/PS1+/- mice model after chronic dosing (6 weeks) with HT-ALZ at 4 different dose levels to determine if there is a dose-dependent response for selection of the human equivalent dose for future clinical trials with HT-ALZ.

Reference:
1Carrion C, Folkvord F, Anastasiadou D, Aymerich M. Cognitive Therapy for Dementia Patients: A Systematic Review. Dement Geriatr Cogn Disord. 2018;46(1-2):1-26. doi: 10.1159/000490851. Epub 2018 Aug 9. PMID: 30092585.

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 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, 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, 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 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 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

SOURCE Hoth Therapeutics, Inc.