NeuroSense Releases Long-Term Survival Data from ALS Clinical Trial
NeuroSense Therapeutics announced the availability of additional long-term survival data from its previously completed PARADIGM Phase 2b clinical trial evaluating PrimeC in patients with amyotrophic lateral sclerosis, or ALS. The updated analysis, based on extended follow-up, demonstrates a clinically meaningful and statistically significant improvement in overall survival for patients treated with PrimeC, compared to those initially assigned to placebo. According to Kaplan-Meier survival estimates, patients who received PrimeC continuously during both the double-blind and open-label phases achieved an estimated median survival of 36.3 months, compared to 21.4 months for patients initially assigned to placebo during the double-blind phase and crossing over to active treatment during the open label extension. This represents over 14-month improvement and approximately a 70% increase in median survival. The survival benefit was sustained over time, with consistent separation between treatment arms throughout the follow-up period. The PARADIGM Phase 2b trial was a randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of PrimeC in 68 people living with ALS. Participants were administered PrimeC or placebo at a 2:1 ratio, respectively, for the six-month double-blind part. NeuroSense continues to engage with regulatory authorities regarding the advancement of PrimeC into pivotal late-stage development and believes these findings add important long-term clinical context to previously reported efficacy results.
