Cambridge, Massachusetts, March 16, 2026
NeuroSense Therapeutics Ltd. announced the publication of results from its PARADIGM Phase 2b clinical trial evaluating PrimeC, an investigational therapy for amyotrophic lateral sclerosis (ALS), in JAMA Neurology. The study demonstrated clinically meaningful outcomes, strong safety profile, and significant biological activity, reinforcing PrimeC’s potential as a disease-modifying treatment for neurodegenerative disorders. The findings mark a critical milestone in ALS research, addressing the urgent need for therapies that can slow disease progression and improve patient outcomes.
Promising Clinical Outcomes in ALS Patients
The PARADIGM study, a randomized, double-blind, placebo-controlled Phase 2b trial, evaluated PrimeC in patients with ALS over a 6-month treatment period followed by a 12-month extension phase. Results showed that continuous treatment with PrimeC significantly slowed functional decline, with patients achieving a 7.92-point advantage in ALSFRS-R scores at 18 months, representing a 36% reduction in disease progression. Additionally, early treatment with PrimeC was associated with a 64% reduction in the risk of ALS-related complications, including respiratory failure, hospitalization, and mortality.
These outcomes highlight the therapy’s ability to deliver clinically meaningful benefits across multiple endpoints, positioning it as a promising candidate for further development in ALS treatment.
Biological Activity Supports Disease Modification
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Beyond clinical outcomes, the study provided strong biomarker evidence supporting PrimeC’s mechanism of action. The therapy demonstrated significant modulation of disease-relevant microRNAs and iron-regulatory biomarkers, which are known to play a critical role in ALS progression. Specifically, PrimeC treatment led to downregulation of ALS-associated microRNAs and stabilization of iron metabolism markers such as transferrin and ferritin, indicating target engagement across multiple biological pathways.
PrimeC is a fixed-dose oral combination therapy designed to simultaneously address neuroinflammation, iron dysregulation, and microRNA-mediated pathways, offering a multi-target approach to disease modification. These findings provide a strong scientific foundation for advancing PrimeC into a Phase 3 clinical trial, with regulatory clearance already obtained to proceed.
Advancing Precision Neurology and Clinical Development
The publication of the PARADIGM trial results in a leading peer-reviewed journal underscores the growing importance of integrating clinical and biomarker data in neurodegenerative disease research. Conducted across multiple international centers, the study demonstrated consistent findings across clinical endpoints and molecular biomarkers, supporting the robustness of the results. NeuroSense’s collaboration with leading institutions such as Mass General Brigham and Barrow Neurological Institute highlights the role of global research partnerships in accelerating therapeutic innovation.
As ALS remains one of the most devastating neurological conditions with limited treatment options, the advancement of PrimeC represents a significant step toward precision medicine approaches in neurology, where therapies are designed to target multiple disease mechanisms simultaneously. The continued development of PrimeC reflects a broader shift in pharmaceutical research toward multi-pathway, data-driven therapies aimed at improving long-term patient outcomes.
Source: NeuroSense press release
