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NeuroSense Recaps Positive 2023 Achievements Including Statistically Significant Slowing of Disease Progression in Phase 2b ALS Trial of PrimeC and Highlights Anticipated 2024 Catalysts
End of Phase 2 meeting with the FDA and EMA expected in Q2 2024 and several biomarker study results anticipated as early as Q1 2024, as the Company advances
About this update from Neurosense Therapeutics Ltd.
[{"type":"text","content":"End of Phase 2 meeting with the FDA and EMA expected in Q2 2024 and several biomarker study results anticipated as early as Q1 2024, as the Company advances partnership discussions \nCAMBRIDGE, Mass., Jan. 9, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (\"NeuroSense\"), a company developing treatments for severe neurodegenerative diseases, shares a review of important clinical achievements in 2023 and provides a road map for anticipated catalysts in 2024.\n\nStatistically Significant Reduction in ALS Disease Progression in Phase 2b PARADIGM Trial\nTop-line results in the Phase 2b PARADIGM trial of PrimeC revealed a statistically significant slowing of disease progression in ALS patients, compared to placebo. The study demonstrated a 37.4% (p=0.03) difference in the FDA-approved ALS functional rating scale revised (ALSFRS-R), compared to placebo, and a strong safety profile. These data highlight a novel approach to treating ALS, with potential implications in other neurodegenerative conditions. PrimeC is a unique fixed-dose combination of ciprofloxacin and celecoxib, which may utilize complementary and synergistic mechanisms to preserve motor neuron health in ALS.\nJeffrey Rosenfeld, MD, PhD, Professor of Neurology at Loma Linda University and member of NeuroSense's Scientific Advisory Board, stated that the magnitude of this apparent improvement is especially noteworthy considering the natural history of ongoing disease progression. Furthermore, Prof. Rosenfeld commented that the most exciting aspects of these data include not only the statistical differences in ALSFRS-R score at the specified timepoints, but also that the improved trajectory of the ALSFRS-R decline was evident from the earliest timepoint, throughout the entire study period. \"These data provide an exciting justification and indication for a pivotal Phase 3 trial. The complexity of ALS pathology warrants a multi-drug therapeutic strategy and it is especially gratifying to see this combination therapy advance. The pending data on biomarkers of neurodegeneration will also be of great interest, as we continue to better understand the benefits of PrimeC and promote this approach.\" \n\"The clinical efficacy seen in the topline PARADIGM trial results demonstrate PrimeC's potential to render a significant and meaningful clinical benefit to people ...