NeuroSense Highlights PARADIGM Clinical Trial Data; Co To Submit 12-Month Data To FDA To Discuss Path Forward
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.
研究结果显示，治疗12个月后，PrimeC在意向治疗人群（ITT）中的无并发症存活率比安慰剂高57％，在预定义的符合协议人群（PP）中则表现出73％（p = 0.02）的优势。NeuroSense打算将这些12个月的结果提交给包括FDA在内的监管机构，以讨论PrimeC的短期发展路径。
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.
此前，NeuroSense报道称，与安慰剂相比，PrimeC显著减缓了疾病进程36％（p = 0.009），并且提高了43％的生存率。符合协议分析揭示了更大的好处，ALSFRS-R评分提高40％（p = 0.003），生存率增加63％，代表了12个月对照ALS研究结果的显著进展。