Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical, announced today proof-of-concept data recorded using cognitive and behavioral assessments in an Alzheimer’s disease mouse model (aged APP/PS1+/- mice), indicating that HT-ALZ has cognitive therapeutic potential after chronic oral dosing. The study was carried out as part of a Sponsored Research Agreement between the firm and Washington University in St. Louis. HT-ALZ is a medication in development for the treatment of dementia associated with Alzheimer’s disease through the 505(b)(2) regulatory procedure (AD).

Carla Yuede, Ph.D., Associate Professor of Psychiatry, and John Cirrito, Ph.D., Associate Professor of Neurology, of Washington University School of Medicine, conducted the chronic dosing experiments, which included a battery of behavioral assessments (e.g., pre-pulse inhibition, novel object recognition, cued and contextual fear conditioning) after >5 weeks oral treatment with HT-ALZ. These behavioral tests are the gold standard for predicting the potential for cognitive, learning, and memory improvement in AD treatments.

After >5 weeks of therapy, all behavioral tests indicated 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. The findings suggest HT-therapeutic ALZ’s promise as an AD treatment for cognitive enhancement.

Dr. Cirrito, according to PressReach, remarked, “Chronic dosing had a considerable influence on four behavioral abnormalities caused by A disease in these mice. Findings like this give reason to believe that the investigational treatment is having an effect on the brain.”

Other assessment procedures conducted at earlier treatment periods (less than five weeks of treatment) with HT-ALZ did not indicate a large improvement compared to vehicle-treated animals but were trending towards improvement; this data suggests a time-dependent improvement after the onset of HT-ALZ treatment, which is consistent with other AD therapeutics 1. These other behavioral tests are being redone following longer HT-ALZ dose intervals (e.g., six weeks).

Alzheimer’s disease (AD) is a neurological disorder characterized by amyloid (A) plaque aggregates and Tau protein neurofibrillary tangles in the brain, which results in clinical manifestations such as dementia. Hoth previously reported on the effect of HT-ALZ on the levels of A in brain interstitial fluid using a recognized Alzheimer’s Disease animal model (aged APP/PS1+/- mice). According to early findings from these studies, HT-ALZ treatment resulted in a significant decrease in A in both male and female APP/PS1+/- mice compared to placebo-treated animals and baseline A levels. More research is being done to determine how HT-ALZ affects A pathology after long-term treatment.

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