Hoth Therapeutics announced the pre-clinical results of its oral soluble film formulation, HT-ALZ, for the treatment of Alzheimer’s disease (AD) and associated symptoms (dementia). The study performed on an established AD mouse model (APP/PS1+/-) showed those receiving over 5 weeks of the oral treatment had significant improvement in spatial memory tests indicating a positive therapeutic potential of HT-ALZ for AD and dementia treatment.
AD, the most common cause of dementia, is a neurodegenerative disease of the brain characterized by aggregates of amyloid β (Aβ) plaques and neurofibrillary tangles of tau protein. The disease develops silently 20-30 years prior to the appearance of symptoms as these misfolded proteins accumulate over the years. There is currently no cure for AD.
Earlier this year Hoth Therapeutics reported a significant reduction in Aβ load among both male and female APP/PS1+/- mice after acute treatment with HT-ALZ compared to placebo-treated animals and baseline Aβ levels. In the present study, aged APP/PS1+/- mice that develop behavioral deficits due to Aβ pathology were chronically treated with HT-ALZ or a placebo. A battery of behavior tests that are considered the gold standard for predicting cognitive, learning, and memory improvement potential for AD therapeutics, were then performed on these animals. While greater than 5 weeks of treatment showed significant improvement in behavioral and cognitive functions, those with less than 5 weeks of treatment only showed a trend towards improvement compared to placebo-treated mice. HT-ALZ treatment therefore results in a time-dependent improvement in cognitive symptoms. Future studies will evaluate the effect of HT-ALZ on memory, anxiety, and executive function following 6 weeks of chronic treatment at four different doses. This will also determine any dose-dependent response pattern that might help in selecting the dose for future clinical trials in humans.
Interestingly, the active pharmaceutical component in HT-ALZ is already an approved drug. This allows the drug development of HT-ALZ to go through the faster and cost-effective 505(b)(2) regulatory pathway where Hoth therapeutics can use any existing data on this component to meet some or all of the safety and efficacy requirements in the application process. Overall, HT-ALZ so far seems to be on track to be a therapeutic potential in reducing Aβ load and cognitive improvement in AD and/ or dementia.
