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NeuroSense Management Provides Corporate Update and First Quarter 2024 Financial Results
Following positive 6-month clinical outcomes from phase 2b (PARADIGM) clinical trial, Company expects additional biomarker and 12-month clinical in the near
About this update from Neurosense Therapeutics Ltd.
[{"type":"text","content":"Following positive 6-month clinical outcomes from phase 2b (PARADIGM) clinical trial, Company expects additional biomarker and 12-month clinical in the near term \nCAMBRIDGE, Mass., June 24, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (\"NeuroSense\"), a company developing novel treatments for severe neurodegenerative diseases, today provides a corporate update following its recently announced analyses from its Phase 2b PARADIGM clinical trial, which demonstrated a statistically significant slowing of disease progression in high-risk ALS patients treated with PrimeC by 43% (p=0.02) as compared to placebo in the pre-specified per protocol (PP) population analysis after six months of treatment.[1] As previously indicated, the slowing of disease progression demonstrated by PrimeC versus placebo translates to a 5.04-point difference in the ALSFRS-R in favor of PrimeC (Confidence Interval: 0.862, 9.214; n=38).\n\nCorporate Highlights for the near term include:\n12-month clinical results, including survival, expected in June 2024FDA meeting anticipated in Q3 2024Started preparations for Phase 3 clinical trial in the US, including protocol submission expected by year-end 2024NeuroSense CEO Alon Ben-Noon states, \"We are continuing to see additional results coming in from the PARADIGM trial and as they are being analyzed and verified, we intend to share them with shareholders. We anticipate sharing 12-month survival data, ALSFRS-R –as well as providing some additional biomarker data. These will include iron, ferritin and transferrin. We are looking forward to presenting target-engagement biomarkers alongside the clinical outcomes. In the meantime, we continue our discussions with several potential partners in order to drive our clinical programs forward efficiently.\"\nIn addition, the Company hereby provides its Q1 2024 financial results:\nResearch and development expenses for the three months ended March 31, 2024 and 2023 were $1.88 and $1.85 million, respectively. Research and development expenses remained at the same level primarily due to an increase in expenses to subcontractors and consultants as well as salaries and social benefits as a result of the progression of the Phase 2b ALS clinical study, which were fully offset by a decrease in share-based compensation expenses. NeuroSense expects research and deve...