NeuroSense Therapeutics(US:NRSN)2025-12-08 14:32NeuroSense Therapeutics Update Summary Company Overview - Company: NeuroSense Therapeutics (NasdaqCM:NRSN) - Focus: Development of therapies for neurodegenerative diseases, particularly ALS and Alzheimer's disease Key Topics Discussed 1. ALS Phase III Study (PARADIGM) - The pivotal PARADIGM trial is set to initiate in mid-2026, focusing on ALS treatment with PrimeC [3][4] - The study aims to confirm previous findings and support future success with PrimeC [4] - The primary endpoint is the ALS Functional Rating Scale (ALS-FRS) adjusted for survival after 12 months [18] - The study is designed to enroll approximately 300 participants across the US, Europe, and Israel [10] 2. Regulatory Progress - Recent FDA clearance allows the initiation of the PARADIGM study [11] - A pre-New Drug Submission (NDS) meeting with Health Canada is scheduled for April 2026 to align on submission strategy [11][31] - New data, including long-term survival and additional biomarkers, will be submitted to Health Canada [38] 3. Alzheimer's Disease Program - The proof of concept phase II program for Alzheimer's disease has completed database lock, with top-line results expected in Q1 2026 [5][12] - The study aims to assess PrimeC's potential to address unmet needs in Alzheimer's [5] 4. Partnership Discussions - Ongoing discussions with a large pharmaceutical company have resulted in a binding term sheet [14] - The company is also engaging with additional potential partners to maintain strategic optionality [15][22] - The partnership strategy aims to maximize long-term value for shareholders [15][34] Financial and Operational Insights - NeuroSense is actively seeking financing options to support the phase III study [20][39] - The company has received interest from leading venture capitalists and is exploring multiple pathways for funding [20] - The phase III study is powered to over 95% to detect the anticipated treatment effect [10] Clinical Insights - PrimeC, the flagship therapy, is a fixed-dose combination of two FDA-approved drugs designed to target chronic inflammation, iron accumulation, and microRNA dysregulation [6][10] - The PARADIGM study has shown a 58% reduction in the risk of death and a 64% reduction in ALS complication-free survival among participants who started treatment with PrimeC [9] - Biomarkers are being integrated into the phase III study to enhance clinical credibility and regulatory confidence [48] Future Milestones - Anticipated top-line data from the PARADIGM study is expected in 2028, with potential for earlier results due to the adaptive design [50] - Key value inflection points include the initiation of the phase III study, results from the Alzheimer's program, and partnership developments [25] Conclusion - NeuroSense is committed to advancing its programs with scientific rigor and creating value for shareholders, with a focus on executing important milestones ahead [51]