NeuroSense Highlights PARADIGM Clinical Trial Data; Co To Submit 12-Month Data To FDA To Discuss Path Forward

In the study, complication-free survival revealed a 57% difference in favor of PrimeC over placebo after 12 months of treatment in the Intent to Treat (ITT) population and demonstrated an outcome of 73% (p=0.02) difference in favor of PrimeC over placebo after 12 months of treatment in the pre-defined Per Protocol Population (PP). NeuroSense intends to submit these 12-month results to regulatory agencies, including the FDA, to discuss PrimeC's path forward in the short term.

Previously, NeuroSense reported that PrimeC significantly slowed disease progression by 36% (p=0.009) and improved survival rates by 43% compared to placebo. The Per-Protocol analysis revealed even greater benefits, with a 40% (p=0.003) improvement in ALSFRS-R scores and a 63% increase in survival rates, representing a distinguished advancement in outcomes for a controlled 12-month ALS study.