NeuroSense PrimeC Slows ALS Progression 36%, Cuts Complications 64%
NeuroSense Therapeutics reported that PrimeC delivered a 7.92-point ALSFRS-R functional score benefit at 18 months, representing a 36% slowing of disease progression (p=0.007). Early treatment with PrimeC reduced ALS-related complication risk by 64% over the same period (p=0.02).
1. PARADIGM Phase 2b Trial Outcomes
The PARADIGM trial enrolled 68 definite or probable ALS patients in a randomized, double-blind, placebo-controlled design with a 6-month treatment period followed by a 12-month open-label extension. Participants who received PrimeC from the outset maintained a 7.92-point ALSFRS-R advantage at 18 months, a 36% slowing in functional decline (p=0.007), and showed a 64% relative reduction in major ALS complications including respiratory failure, hospitalization, or death (p=0.02).
2. Safety Profile and Biomarker Activity
PrimeC demonstrated a safety profile comparable to placebo over 18 months, with most treatment-related adverse events classified as mild to moderate and transient. Biological analyses showed significant modulation of disease-relevant biomarkers, including preservation of transferrin levels, stabilization of ferritin, and downregulation of ALS-associated microRNAs, supporting its multi-pathway mechanism.
3. Advancement to Phase 3
Consistent clinical and biomarker findings have informed the design of a confirmatory Phase 3 trial, which has received FDA clearance to proceed. The upcoming study will aim to validate PrimeC’s disease-modifying impact in a larger ALS population with endpoints based on functional decline and complication-free survival.