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

Findings Demonstrate Meaningful Clinical Outcomes and Biological Activity

Mar. 16, 2026 at 8:33pm

Got story updates? Submit your updates here. ›

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, so the positive results from the PARADIGM trial provide hope for a potential new therapy that could meaningfully alter the course of the disease. The consistency across clinical outcomes and biomarkers strengthens the scientific rationale for advancing PrimeC into a larger confirmatory Phase 3 trial.

The details

The PARADIGM trial was a randomized, double-blind, placebo-controlled study that evaluated the safety, biological activity, and potential clinical effects of PrimeC, a novel fixed-dose oral combination therapy designed to target multiple mechanisms implicated in ALS progression. The study found that continuous treatment with PrimeC was associated with slower functional decline, a 64% relative reduction in risk of ALS-related complications, and significant modulation of ALS-related biomarkers.

  • The PARADIGM trial enrolled participants from March 2024 to September 2025.
  • The double-blind treatment period lasted 6 months, followed by a 12-month open-label extension.

The players

NeuroSense Therapeutics Ltd.

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

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 that published the results of the PARADIGM trial.

Got photos? Submit your photos here. ›

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 and corresponding author of the JAMA Neurology publication

What’s next

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

The takeaway

The consistent findings from the PARADIGM trial, including slower functional decline, reduced risk of ALS-related complications, and modulation of disease-relevant biomarkers, provide strong scientific support for the continued development of PrimeC as a potential disease-modifying therapy for ALS, a devastating neurodegenerative disease with limited treatment options.