NeuroSense Therapeutics Ltd. announced positive preliminary results from a novel biomarker study conducted to evaluate the potential of NeuroSense's combination platform therapy for the treatment of Parkinson's disease (PD), the second most common neurodegenerative disorder. This study compared blood samples from 30 healthy individuals to 30 people living with PD by utilizing neuronal derived exosomes to identify modulations in PD-associated biomarkers, including AG02. AG02 (Argonaute 2), the catalytic subunit of the protein complex responsible for RNA-induced silencing, was shown to be critical to the regulation of alpha-synuclein (aSyn) accumulation in dopaminergic neurons of thestantia nigra pars compacta, the region of the brain that is responsible for motor control.

Theysregulation of aSyn through dysfunction of AGO2 can have detrimental effects in the brain, which can lead to PD. In the PD biomarker study, NeuroSense observed a statistically significant (p= 0.002) decrease in levels of AGO2 in newly diagnosed PD patients (n=15) when compared to the healthy control group. There were no significant changes observed in AGO2 levels of more advanced stage PD patients, indicating this trend could be related to disease onset.

In a Phase 2a clinical trial conducted in people living with amyotrophic lateral sclerosis (ALS), NeuroSense's platform combination therapy was observed to induce a statistically significant (p=0.039) increase of AGO2 and also showed a trend of increased levels of LC3 (p= 0.054). LC3 is an essential protein involved in autophagy, a cellular recycling process utilized to degrade aggregated proteins and damaged organelles, which has been reported to be involved in many neurodegenerative disorders, including PD. In the PD biomarkers observed a change in levels of LC3, which decreased in newly diagnosed PD patients (p= 0.034), suggesting an impairment in cellular recycling processes.

Other biomarkers that were measured, including some PD-specific markers, did not reveal trends and may be revisited in future studies.