, /PRNewswire/ -- ( : NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today reported statistically significant results from the 12-month data analysis of the PARADIGM Phase study evaluating PrimeC in people living with Amyotrophic Lateral Sclerosis (ALS). The data show a significant improvement in the rate of decline of ALS Functional Rating Scale-Revised (ALSFRS-R) scores and survival rates for subjects who received PrimeC from the start of the trial compared to those who started on placebo. Specifically, the intent to treat (ITT) analysis of the study at 12 months revealed a difference of 6.
5 points in the ALSFRS-R, which represents a 36% improvement and a highly statistically significant P value of 0.009. In addition, at 12 months participants on PrimeC demonstrated better survival than those initially on placebo, by 43%.
In an additional pre-defined analysis of the Per-Protocol Population at 12 months, the results showed an even greater effect, with a difference of approximately 7.7 points (p=0.003) between the groups, translating to more than 40% improvement for participants who received PrimeC from the start compared to those on placebo.
Furthermore, this analysis indicated that the survival rate of participants on PrimeC improved by 63% compared to participants who received a placebo. "These exciting long-term results demonstrate how study participants experienced more slowing of progr.