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NeuroSense's PARADIGM ALS Clinical Trial Demonstrates Up to 73% Improved Complication-Free Survival Following Statistically Significant Slowing of Disease Progression
NeuroSense to submit the 12-month data to FDA to discuss path forward CAMBRIDGE, Mass., July 9, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:
About this update from Neurosense Therapeutics Ltd.
[{"type":"text","content":"NeuroSense to submit the 12-month data to FDA to discuss path forward\nCAMBRIDGE, Mass., July 9, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (\"NeuroSense\"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, announces additional positive results from its 12-month PARADIGM Phase 2b study of PrimeC in ALS patients. 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.\n\nPreviously, 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.\nOther positive clinical data points included Slow Vital Capacity (SVC) improvement from a 13% difference after 6 months to a 20% difference after 12 months in the ITT population, in favor of PrimeC, and from a 17% difference after 6 months to a 19% difference after 12 months in the PP population, in favor of PrimeC. Furthermore, an analysis exploring the rate of decline, defined as a drop of 4 points or less in the ALSFRS-R after 12 months, revealed a ratio of 4.5 to 1 in favor of PrimeC over placebo. This outcome underscores the importance of early treatment and the potential of PrimeC as a disease-modifying drug.\n\"The latest results from the PARADIGM study are incredibly encouraging and provide compelling evidence of PrimeC's potential to significantly benefit people living with ALS. The substantial improvement in complication-free survival and the consistent slowing of disease progression highlight PrimeC's promise as an effective treatment. Given that, for many clinicians and people with ALS, therapeutic options have recently been significantly limited; the urgency for ...