NeuroSense Therapeutics Ltd. announced final results from a biomarker study conducted to evaluate the potential of NeuroSense's combination platform therapy for the treatment of Alzheimer's disease (AD). Preliminary results from the study, showed that TDP-43, a novel biomarker, was elevated in AD patients compared to a healthy control group. Based on these encouraging preliminary results, NeuroSense expanded the study with a larger healthy control group to further validate the results.

TDP-43 has been known to colocalize with senile plaques and neurofibrillary tangles, suggesting a direct interaction between TDP-43 and amyloid- (A) or tau, which are known to be hallmark biomarkers in AD. TDP-43 has been found in up to 57% of AD cases and aggregates of TDP-43 have been shown to be cytotoxic both in vitro and in vivo.(1) NeuroSense's platform combination therapy technology has already shown a statistically significant reduction of TDP-43 in a Phase 2a clinical trial biomarker study in another neurodegenerative disease, amyotrophic lateral sclerosis (ALS), and is now being evaluated in a Phase 2b ALS double-blind clinical trial. NeuroSense believes these most recent biomarker results show the importance of TDP-43 pathology in AD and suggest the potential efficacy of NeuroSense's platform technology in Alzheimer's disease.

NeuroSense plans to commence a Phase 2 double-blind proof-of-concept study in Alzheimer's disease in the first half of 2023.