NeuroSense Therapeutics Ltd. (NASDAQ: NRSN), a late-clinical stage biotech company focused on neurodegenerative diseases, announced encouraging new findings from plasma samples collected in its Phase 2b PARADIGM study. The data show that PrimeC, the company’s lead drug candidate, produced statistically significant reductions in multiple microRNAs (miRNAs) implicated in Alzheimer’s disease (AD) pathology, suggesting a decrease in neuroinflammatory and neurodegenerative activity.
Key Findings
- Significant reductions in AD-associated microRNAs were observed with PrimeC treatment:
- miR-146a-5p (p=0.007)
- miR-21-5p (p=0.003)
- miR-let-7a-5p (p=0.028)
- miR-let-7e-5p (p=0.006) - Placebo group showed no significant changes over time.
- These miRNAs are linked to neuroinflammation, amyloid and tau pathology, synaptic dysfunction, and cognitive decline.
- Reduction of these biomarkers suggests that PrimeC targets core biological pathways of AD, supporting its potential as a disease-modifying therapy.
Alon Ben-Noon, CEO of NeuroSense, stated:
"These biomarker data provide a clearer view of how our novel combination modulates biological pathways implicated in Alzheimer's disease. The magnitude and consistency of the observed miRNA changes are highly encouraging and, together with our Phase 2 clinical findings, will inform the design of follow-on AD studies, all while we continue to advance PrimeC's Phase 3 readiness program in ALS."
About Alzheimer’s Disease
AD is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting over 30 million people. Current therapies provide limited symptomatic relief, leaving a strong unmet need for disease-modifying treatments that slow or halt progression. Therapeutics like PrimeC, which target multiple disease mechanisms simultaneously, hold promise for meaningful patient benefit.
About PrimeC
PrimeC is an extended-release oral formulation combining two FDA-approved drugs: ciprofloxacin and celecoxib. It is designed to synergistically address mechanisms central to ALS and AD, including neuron degeneration, inflammation, iron accumulation, and RNA dysregulation, aiming to inhibit disease progression.
About PARADIGM
The PARADIGM trial (NCT05357950) is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b study of PrimeC in ALS:
- 68 participants across Canada, Italy, and Israel
- 45 received PrimeC and 23 received placebo for the first 6 months
- Followed by a 12-month open-label extension where all participants received PrimeC in a blinded manner
- Most participants continued standard ALS therapy (Riluzole), with PrimeC showing additional disease-slowing effects
About NeuroSense
NeuroSense Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing therapies for neurodegenerative diseases including ALS, AD, and Parkinson’s disease. Its strategy focuses on combined therapies targeting multiple pathways implicated in these complex conditions.