ALS Disease update: NeuroSense’s PrimeC Shows Groundbreaking ALS Results

San Diego, April 8, 2025 – NeuroSense Therapeutics (NASDAQ: NRSN) has announced landmark data from its Phase 2b PARADIGM trial for PrimeC, a novel amyotrophic lateral sclerosis (ALS) therapy, revealing a 33% reduction in disease progression and a 58% improvement in survival rates over 18 months. The findings, presented at the 77th Annual American Academy of Neurology (AAN) Meeting, position PrimeC as a potential breakthrough in ALS treatment, with Phase 3 trials and early commercialization plans now underway.

Key Clinical Breakthroughs: miRNA Modulation Drives Efficacy

PrimeC’s success lies in its unique ability to modulate microRNAs (miRNAs)—small molecules regulating gene expression linked to neurodegenerative diseases. Data showed:

161 miRNAs consistently downregulated in PrimeC-treated patients versus placebo.
Significant suppression of ALS-associated miR-199 and miR-181, biomarkers tied to disease progression and survival.
Biomarker confirmation of PrimeC’s biological activity, reinforcing its disease-modifying potential.

“These results validate PrimeC’s mechanism of action and its capacity to alter ALS’s trajectory,” said Dr. Jeffrey Rosenfeld of Loma Linda University, who co-led the research with Prof. Noam Shomron of Tel Aviv University.

Phase 3 FDA Alignment and Commercial Strategy

NeuroSense has aligned its Phase 3 trial design with the FDA, with enrollment set to begin in 2025. The company is actively pursuing partnerships to accelerate PrimeC’s development and plans early commercialization in Canada, projecting peak annual revenues of 100M–100M–150M.

Financial Resilience Amid Clinical Progress

NeuroSense’s 2024 financial report highlights strategic cost management:

R&D expenses down 21.9% to $5.7M.
G&A costs reduced by 12.5% to $4.2M.
Year-end cash reserves of **3.4M∗∗,withanetlossof3.4M∗∗,withanetlossof10.2M—typical for clinical-stage biotechs.

AAN Presentations Spotlight PrimeC’s Dual Impact

At the AAN meeting, two pivotal sessions underscored PrimeC’s promise:

Dr. Jeremy Shefner (2:24 PM PT): Detailed PrimeC’s safety, efficacy, and biomarker data, emphasizing its statistically significant slowdown in ALS progression (p=0.007).
Dr. Rosenfeld (6:15 PM PT, Late-Breaker Session): Explored PrimeC’s impact on iron-related pathways and miRNA networks, critical in ALS pathology.

What’s Next for NeuroSense and ALS Patients?

With Phase 3 trials on the horizon and Canadian commercialization plans, NeuroSense aims to address the urgent unmet need in ALS. “PrimeC could redefine treatment paradigms,” said CEO Alon Ben-Noon. “We’re committed to bringing this therapy to patients globally.”

Stay tuned to PharmacyInfoLine.com for updates on PrimeC’s development and breakthroughs in neurodegenerative therapies.