NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced positive biomarker findings from its Phase 2, randomized, double-blind, placebo-controlled proof-of-concept RoAD study (NST-AD-001) of PrimeC in Alzheimer's disease (AD).

The RoAD clinical trial enrolled eight participants, randomized to PrimeC or placebo. Three participants completed a 12-month follow-up period, with both CSF and plasma samples collected at three timepoints.

The plasma biomarker analysis showed multiple, distinctive protein biomarker changes. Most notably, these included changes in the hallmark protein biomarkers of AD - brain-derived tau (total) and phospho-tau(s) as well as the amyloid-beta 42/40 ratio. Distinctive changes were also found in the levels of other major neurodegenerative disease misfolding proteins: alpha-synuclein (total, oligomeric and p129) and TAR DNA-binding protein 43 ("TDP-43," both total and p409). TDP-43 is the hallmark of ALS while Parkinson's and dementia with Lewy bodies are characterized by accumulations of alpha-synuclein. These pathological proteins commonly co-occur with Alzheimer's disease. Either (or both) of these may be present in more than 50% of Alzheimer's disease cases, and when co-pathology is present, it is associated with faster and/or more severe dementia. Finally, additional changes were observed in key biomarkers of oxidative stress and inflammation affecting proteostasis and neurodegeneration. All of these changes were directionally consistent with PrimeC's proposed mechanism of action and align with biomarker effects previously observed in the Company's ALS program, supporting engagement of shared neurodegenerative pathways.