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.
研究結果顯示，治療12個月後，PrimeC在意向治療人群（ITT）中的無併發症存活率比安慰劑高57％，在預定義的符合協議人群（PP）中則表現出73％（p = 0.02）的優勢。NeuroSense打算將這些12個月的結果提交給包括FDA在內的監管機構，以討論PrimeC的短期發展路徑。
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報道稱，與安慰劑相比，PrimeC顯著減緩了疾病進程36％（p = 0.009），並且提高了43％的生存率。符合協議分析揭示了更大的好處，ALSFRS-R評分提高40％（p = 0.003），生存率增加63％，代表了12個月對照ALS研究結果的顯著進展。