NeuroSense Therapeutics announced breakthrough findings from its PARADIGM clinical trial of PrimeC for ALS treatment. The trial demonstrated significant regulation of microRNAs (miRNAs) in ALS patients, with PrimeC showing a clear ability to influence key genetic markers controlling ALS progression. The placebo group showed no similar changes, highlighting PrimeC's potential as a disease-modifying treatment.Previously reported data from the 6-month double-blind segment showed a 29% difference in favor of PrimeC vs placebo in the intent to treat population. In the PP top-line analysis, a statistically significant 37.4% (p=0.03) difference was observed in ALSFRS-R favoring PrimeC over placebo. The drug demonstrated effectiveness beyond the FDA-approved standard of care medication, Riluzole.The trial included 68 participants across Canada, Italy, and Israel, with 96% of participants choosing to continue treatment in a 12-month open-label extension. PrimeC, a novel extended-release oral formulation combining ciprofloxacin and celecoxib, has received Orphan Drug Designation from both the FDA and European Medicines Agency.

NeuroSense Therapeutics announced breakthrough findings from its PARADIGM clinical trial of PrimeC for ALS treatment. The trial demonstrated significant regulation of microRNAs (miRNAs) in ALS patients, with PrimeC showing a clear ability to influence key genetic markers controlling ALS progression. The placebo group showed no similar changes, highlighting PrimeC's potential as a disease-modifying treatment.Previously reported data from the 6-month double-blind segment showed a 29% difference in favor of PrimeC vs placebo in the intent to treat population. In the PP top-line analysis, a statistically significant 37.4% (p=0.03) difference was observed in ALSFRS-R favoring PrimeC over placebo. The drug demonstrated effectiveness beyond the FDA-approved standard of care medication, Riluzole.The trial included 68 participants across Canada, Italy, and Israel, with 96% of participants choosing to continue treatment in a 12-month open-label extension. PrimeC, a novel extended-release oral formulation combining ciprofloxacin and celecoxib, has received Orphan Drug Designation from both the FDA and European Medicines Agency.