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.
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/
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