JAMA Neurology Publishes Results from PARADIGM Phase 2b Trial of PrimeC in ALS

Study demonstrates meaningful clinical outcomes and biological activity of PrimeC in treating amyotrophic lateral sclerosis

Mar. 16, 2026 at 4:27pm

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The Journal of the American Medical Association (JAMA Neurology) has published results from the PARADIGM Phase 2b clinical trial evaluating NeuroSense's investigational therapy PrimeC in people living with amyotrophic lateral sclerosis (ALS). The publication highlights consistent clinical and biomarker findings, including slower functional decline, reduced risk of ALS-related complications, and modulation of disease-relevant biomarkers.

Why it matters

ALS is a devastating neurodegenerative disease with limited treatment options. The PARADIGM study results provide promising evidence that PrimeC, a novel combination therapy designed to address multiple biological pathways involved in ALS progression, could offer meaningful clinical benefits for patients. These findings support the continued development of PrimeC as a potential disease-modifying therapy for ALS.

The details

The PARADIGM study was a randomized, double-blind, placebo-controlled Phase 2b trial that evaluated the safety, biological activity, and potential clinical effects of PrimeC over an 18-month period. PrimeC demonstrated a favorable safety profile and was associated with slower functional decline, a 64% reduction in risk of ALS-related complications, and modulation of disease-relevant biomarkers like iron metabolism and microRNA levels.

  • The PARADIGM trial enrolled participants between 2023 and 2025.
  • The 6-month double-blind treatment period was followed by a 12-month open-label extension.
  • The results were published in JAMA Neurology on March 16, 2026.

The players

NeuroSense Therapeutics Ltd.

A late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, including ALS.

Merit Cudkowicz, MD, MSc

Director of the Healey & AMG Center for ALS at Mass General Brigham and Julieanne Dorn Professor of Neurology at Harvard Medical School.

Jeremy M. Shefner, MD, PhD

Professor of Neurology at the Barrow Neurological Institute and corresponding author of the JAMA Neurology publication.

Ferenc Tracik, MD

Chief Medical Officer of NeuroSense Therapeutics.

JAMA Neurology

A prestigious medical journal published by the American Medical Association that focuses on neurology research.

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What they’re saying

“ALS is one of the most serious neurological diseases, and there is an urgent need for therapies that can meaningfully alter its course. What is particularly noteworthy about the PARADIGM results is the consistency of the findings across clinical outcomes and disease-relevant biomarkers, in addition to good safety. These results provide a strong scientific rationale for continuing the clinical development of PrimeC and support its evaluation in a larger confirmatory Phase 3 trial.”

— Merit Cudkowicz, MD, MSc, Director of the Healey & AMG Center for ALS at Mass General Brigham and Julieanne Dorn Professor of Neurology at Harvard Medical School

“What stands out about the PARADIGM study is the multiple clinical endpoints suggest the same level of clinical benefit and that multiple biomarkers are consistent with clinical endpoints. Together, these findings provide a strong scientific foundation for advancing PrimeC into a Phase 3 trial designed to validate its impact for patients.”

— Jeremy M. Shefner, MD, PhD, Professor of Neurology at the Barrow Neurological Institute

What’s next

NeuroSense has received FDA clearance to proceed with a Phase 3 clinical trial to further evaluate the efficacy of PrimeC in ALS.

The takeaway

The consistent positive findings from the PARADIGM study, including slowed functional decline, reduced ALS complications, and modulation of disease biomarkers, provide strong scientific support for the continued development of PrimeC as a potential new treatment option that could meaningfully improve outcomes for people living with this devastating neurodegenerative disease.