ALS News TodayEarly PrimeC Treatment Extends ALS Survival by 14 Months: Long-Term Data

Continuous PrimeC treatment achieved 36.3-month median survival versus 21.4 months with delayed initiation, with Phase 3 trial now FDA-cleared.

🔬 Clinical Considerations

• 65% reduction in risk of death versus delayed treatment; early initiation drove a 70% increase in median survival over the delayed-start group
• 37.4% slowing of ALSFRS-R decline in protocol-adherent patients during the 6-month randomized phase, with benefits sustained through the open-label extension
• PrimeC combines ciprofloxacin and celecoxib in extended-release oral form, targeting neuroinflammation and excess iron accumulation, which are both implicated in motor neuron death
• Phase 3 PARAGON trial (up to 300 patients, US and Europe, 12-month randomized treatment) is now FDA-cleared and enrolling; results will determine regulatory pathway

🎯 Practice Applications

• Discuss PrimeC Phase 3 enrollment eligibility with newly diagnosed ALS patients before disease progression limits participation
• Counsel patients that early treatment initiation drove substantially better outcomes than delayed start in Phase 2b data
• Monitor for PARAGON trial site openings to facilitate referrals for eligible patients

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