NeuroSense Therapeutics Reports Positive Phase 2b Biomarker Data for PrimeC in Alzheimer’s Disease

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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!