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JAMA Neurology Publishes Results from PARADIGM Phase 2b Trial of PrimeC in ALS Demonstrating Meaningful Clinical Outcomes and Biological Activity

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  • NeuroSense Therapeutics announced the publication of Phase 2b PARADIGM trial results for PrimeC in ALS in JAMA Neurology.
  • PrimeC is a fixed-dose oral combination of celecoxib and ciprofloxacin designed to target neuroinflammation, iron dysregulation, & microRNA pathways.
  • The trial was a randomized, double-blind, placebo-controlled study involving 68 participants across Italy, Canada, & Israel.
  • PrimeC demonstrated a safety profile comparable to placebo over 18 months with mostly mild to moderate adverse events.
  • Continuous PrimeC treatment resulted in a 7.92-point advantage in ALSFRS-R scores at 18 months, representing over 36% slowing of disease progression.
  • Early initiation of PrimeC was associated with a 64% relative reduction in the risk of ALS-related complications such as respiratory failure, hospitalization, or death.
  • Significant improvement in bulbar function was observed, which is a key determinant of speech, swallowing, & quality of life.
  • Biological evidence showed modulation of iron-regulatory biomarkers including preserved transferrin levels & stabilized ferritin.
  • Plasma microRNA analysis revealed significant downregulation of ALS-associated microRNAs linked to disease severity.
  • Findings support the advancement of PrimeC to a confirmatory Phase 3 clinical trial which has received FDA clearance.