Hoth Therapeutics, Inc., a patient-focused biopharmaceutical company, 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).
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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).