NeuroSense Therapeutics , a clinical-stage biotechnology company developing treatments for severe neurodegenerative diseases, has announced promising new findings from its Phase 2b PARADIGM clinical trial. The data demonstrate a significant impact of PrimeC—its investigational therapy for amyotrophic lateral sclerosis (ALS)—on microRNA (miRNA) modulation, reinforcing the therapy’s potential as a disease-modifying treatment.

The findings mark a critical advancement in understanding PrimeC’s mechanism of action, suggesting that the therapy may slow disease progression in ALS patients. The results reveal consistent modulation of miRNAs linked to ALS pathology, including the downregulation of miR-199 and miR-181—both of which are typically upregulated in ALS and associated with neuroinflammation, reduced neuronal survival, and increased mortality risk.

The data align with previously reported clinical benefits from the PARADIGM trial, where PrimeC demonstrated a 33% reduction in disease progression and a 58% improvement in survival rates. Across all time points in the double-blind study period, 161 mature miRNAs were consistently downregulated in PrimeC-treated patients, while no significant changes were observed in the placebo group.

These results were presented by Dr. Jeffrey Rosenfeld of Loma Linda University during a Late Breaker session at the 77th Annual Meeting of the American Academy of Neurology (AAN) in San Diego. The research was conducted in collaboration with Prof. Noam Shomron of Tel Aviv University, a leading expert in microRNA and functional genomics.

Prof. Shomron highlighted the consistency and specificity of miRNA modulation, noting that the observed changes were compelling and indicative of PrimeC’s direct influence on critical molecular pathways in ALS.

As NeuroSense advances PrimeC’s development, the company is also focusing on expanding mechanistic understanding and identifying miRNA-based biomarkers to help predict and monitor treatment response. The strength of the Phase 2b data provides a strong foundation for upcoming studies and supports the broader therapeutic potential of PrimeC in ALS and other neurodegenerative conditions.

Source:https://www.neurosense-tx.com/from_the_media/neurosense-therapeutics-announces-transformative-phase-2b-microrna-data-highlighting-primecs-promise-as-a-disease-modifying-als-treatment/