NeuroSense Secures FDA Clearance to Launch Pivotal Phase 3 Trial of PrimeC for ALS

NeuroSense Secures FDA Clearance to Launch Pivotal Phase 3 Trial of PrimeC for ALS

By, Admin 27 November 2025

NeuroSense Therapeutics has hit a major milestone. The FDA has cleared the company to begin its pivotal phase 3 PARAGON trial evaluating PrimeC, its lead drug candidate for amyotrophic lateral sclerosis (ALS).

This marks a significant advance for a disease with few effective treatment options.

What FDA Clearance Means?

With the IND amendment approved, NeuroSense can now initiate the trial. The company expects to enroll the first patient in the coming months after securing the required strategic resources.

PARAGON will build on the momentum of PARADIGM, NeuroSense’s phase 2b study, which showed:

  • Promising clinical outcomes
  • Biomarker improvements
  • Strong safety and tolerability

The phase 3 study is powered at over 95% to meet its primary endpoint.

Inside the PARAGON Phase 3 Trial

PARAGON is designed as a global, prospective, double-blind, placebo-controlled trial.

Key details:

  • 300 ALS patients will be enrolled
  • Randomization: 2:1 (PrimeC : Placebo)
  • 12-month treatment period
  • Open-label extension for long-term evaluation
  • Adaptive design enabling interim analyses for sample-size adjustments and early efficacy or futility signals
  • Trial expected across the US and EU

This structure aims to accelerate insights while maintaining rigorous scientific standards.

Why This Matters for ALS?

ALS is an aggressive and incurable neurodegenerative disease.
Patients typically face complete paralysis and death within 2–5 years of diagnosis.

Key stats:

  • 5,000+ new cases annually in the U.S.
  • $1 billion annual economic burden
  • 24% increase in ALS prevalence expected by 2040 across the US and EU

The need for meaningful therapies has never been greater.

What Makes PrimeC Different?

PrimeC is a novel extended-release oral combination built from two FDA-approved drugs:

  • Ciprofloxacin
  • Celecoxib

The formulation is engineered to target multiple disease pathways simultaneously, including:

  • Motor neuron degeneration
  • Inflammation
  • Iron accumulation
  • Impaired RNA regulation

The goal: Slow or potentially inhibit the progression of ALS and Alzheimer’s-related mechanisms.

What NeuroSense Says?

CEO Alon Ben-Noon highlighted the significance of this moment:

“This FDA clearance marks a meaningful advancement for NeuroSense and for people living with ALS. We remain committed to delivering a meaningful therapy.”

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