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A new ALS drug combo is turning heads. PrimeC, an oral combination of ciprofloxacin and celecoxib, significantly reduced a key ALS biomarker (NDE-TDP-43) by ~20% compared to placebo in the Phase 2b PARADIGM trial — and the gap kept widening over 18 months. These findings are now shaping the design of the larger, global Phase 3 PARAGON trial, set to enroll ~300 participants primarily in the US.
A promising ALS drug combo is moving to Phase 3
PrimeC — an oral, extended-release fixed-dose combination of ciprofloxacin and celecoxib developed by NeuroSense Therapeutics — has shown meaningful biomarker and clinical signals in the Phase 2b PARADIGM trial, and those findings are now driving the design of the global Phase 3 PARAGON trial. Results were presented at the 2026 NEALS Annual Meeting by Dr. Merit Cudkowicz of Massachusetts General Hospital.
The trial's standout finding: PrimeC reduced plasma neuron-derived exosomal TDP-43 (NDE-TDP-43) — a hallmark of ALS pathology — by approximately 20% versus placebo at 6 months, with the gap continuing to widen through 18 months. The drug also modulated iron-regulatory proteins and ALS-associated microRNAs, suggesting a broad, multi-target mechanism of action.
By the Numbers:
Why it matters: ALS remains a devastating disease with very limited treatment options. PrimeC's ability to reduce a core pathological marker while also showing functional and survival signals — even in a small trial — makes it one of the more compelling ALS candidates in development. The Phase 3 PARAGON trial will be the true test.
