NeuroSense Therapeutics Marks Major Clinical Milestone: PrimeC Shows Promise in Halting ALS Progression Amid Improved Financial Position

NeuroSense Therapeutics Ltd. (Nasdaq: NRSN), a clinical-stage biotech firm focused on severe neurodegenerative disorders, announced encouraging Phase 2b data for its investigational therapy PrimeC in amyotrophic lateral sclerosis (ALS), alongside year-end 2024 financial results. The company’s lead asset demonstrated the ability to significantly decelerate disease advancement in the 68-patient PARADIGM trial, positioning NeuroSense for potential Phase 3 advancement and eventual market entry.

Clinical Breakthrough Underscores PrimeC’s Therapeutic Potential

The PARADIGM Phase 2b study met its dual endpoints, with PrimeC demonstrating a 33% reduction in disease progression velocity (as measured by ALSFRS-R scoring) over an 18-month observation period (p=0.007). Beyond slowing motor neuron deterioration, the compound reduced the composite risk of mortality, intensive care admission, and respiratory interventions by 58%, translating to improved survival outcomes. Notably, patients experienced preserved function in speech and swallowing—two critical domains frequently impaired in ALS—while tolerating the medication well.

“2024 represents a turning point for NeuroSense Therapeutics,” stated CEO Alon Ben-Noon. “Our PARADIGM trial validates PrimeC’s disease-modifying capacity in a condition with profound medical need. The FDA’s alignment on our Phase 3 protocol following our Type C meeting reinforces our confidence to advance toward the next developmental stage.”

Path Forward: Regulatory and Commercial Strategy

Building on these results, NeuroSense Therapeutics is actively pursuing partnership discussions to co-develop and commercialize PrimeC. The company has secured FDA concurrence on its proposed Phase 3 study design, with enrollment anticipated to commence in 2025. Additionally, NeuroSense plans to pursue early-stage commercialization in Canada, where analysts estimate peak annual revenue potential between $100 million and $150 million.

Intellectual property protections were strengthened when the U.S. Patent and Trademark Office granted a key patent for PrimeC’s proprietary formulation, extending exclusivity through 2042.

Financial Health Supports Continued Development

NeuroSense Therapeutics reported research and development expenses of $5.7 million in 2024, down 21.9% from $7.3 million in 2023, primarily due to streamlined subcontractor spending and reduced share-based compensation. General and administrative expenditures totaled $4.2 million in 2024 versus $4.8 million the prior year, a 12.5% decline attributed to workforce optimization and lower professional insurance costs, partially offset by increased consulting fees.

As of December 31, 2024, NeuroSense Therapeutics maintained $3.4 million in cash reserves. Total assets reached $4.6 million, while shareholders’ equity improved to $2.6 million from a deficit position of $1.8 million in 2023. The net loss for the year was $10.2 million, or $0.54 per diluted share, compared to $10.1 million ($0.74 per share) in 2023.

Understanding the Disease Context

Amyotrophic lateral sclerosis affects approximately 5,000 newly diagnosed individuals annually in the United States, with typical disease progression leading to complete paralysis and mortality within 24 to 60 months. Current therapeutic options remain limited, and the global ALS population is projected to expand by 24% across the U.S. and European Union by 2040, creating substantial clinical demand.

About PrimeC and NeuroSense Therapeutics

PrimeC represents a fixed-dose combination of ciprofloxacin and celecoxib—two established pharmaceuticals reformulated as an extended-release oral treatment. The combination is engineered to simultaneously address multiple pathological mechanisms in ALS, including neuroinflammation, oxidative iron deposition, and dysregulated RNA processing. An earlier Phase 2a trial confirmed safety and demonstrated measurable improvements in functional stability and respiratory parameters alongside biomarker changes suggesting biological activity. Both the FDA and European Medicines Agency have granted PrimeC orphan drug status.

NeuroSense Therapeutics focuses on translating scientific insights into combination therapies targeting multiple disease pathways across neurodegenerative conditions including Parkinson’s disease and Alzheimer’s disease.