NeuroSense Advances Toward Key Regulatory Milestones with Strengthened Data Package and Near-Term Alzheimer's Readout Accessibility StatementSkip NavigationCAMBRIDGE, Mass., March 24, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd.(NASDAQ: NRSN) ("NeuroSense"), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today provided an update on key regulatory and clinical milestones for its lead asset, PrimeC.Health Canada Pre-NDS Meeti ...

PrimeC New Data to Be Presented at AD/PDâ"¢ 2026 Conference Accessibility StatementSkip Navigation Dr. Christian Lunetta to Present "From PARADIGM to PARAGON: Advancing PrimeC for ALS through Phase 2 Clinical and Biomarker Insights toward a Global Phase 3 Trial" CAMBRIDGE, Mass., March 18, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd.(NASDAQ: NRSN) ("NeuroSense"), a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, today announce ...

Core Insights - The publication in JAMA Neurology presents significant findings from the PARADIGM Phase 2b trial of PrimeC in ALS, indicating meaningful clinical outcomes and biological activity [1][5][6] Study Overview - PARADIGM was a randomized, double-blind, placebo-controlled trial assessing PrimeC's safety and efficacy over a 6-month treatment period followed by a 12-month open-label extension [3][8] - The trial enrolled 68 participants with definite or probable ALS, randomized in a 2:1 ratio to receive PrimeC or placebo [8] Clinical Outcomes - PrimeC treatment resulted in a 64% relative reduction in the risk of ALS-related complications, including respiratory failure and hospitalization (p=0.02) [6][10] - Continuous treatment with PrimeC showed a 7.92-point advantage in ALSFRS-R at 18 months, representing over a 36% benefit in slowing disease progression (p=0.007) [6][9] - Significant improvement in bulbar function was observed (p=0.001) [6][9] Safety Profile - PrimeC demonstrated a safety profile comparable to placebo over 18 months, with most treatment-related adverse events being mild to moderate and transient [6][7] Biomarker Findings - The trial showed significant modulation of ALS-related microRNAs and iron-regulatory biomarkers, supporting PrimeC's biological activity [6][12] - Favorable changes in markers of iron metabolism were observed, including preservation of transferrin levels and stabilization of ferritin [11][12] Future Development - The findings support the advancement of PrimeC to a Phase 3 clinical trial, which has received FDA clearance [6][7][8] - The consistent results across clinical outcomes and biomarkers provide a strong scientific foundation for further evaluation of PrimeC as a potential disease-modifying therapy [6][7][12]

Core Insights - NeuroSense Therapeutics is set to present long-term survival data from its Phase 2b PARADIGM trial of PrimeC for ALS at a scientific conference on March 9, 2026, highlighting a significant 65% reduction in risk of death and a median survival benefit of over 14 months [1][2] Company Overview - NeuroSense Therapeutics is a late-stage clinical biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, including ALS, Alzheimer's, and Parkinson's [1] - The company aims to address significant unmet medical needs in neurodegenerative diseases, which currently have limited effective therapeutic options [1] Product Information - PrimeC is NeuroSense's lead drug candidate, an extended-release oral formulation combining two FDA-approved drugs: ciprofloxacin and celecoxib, designed to target multiple mechanisms involved in ALS and Alzheimer's disease [1] - The Phase 2b PARADIGM trial involved 68 ALS patients, demonstrating statistically significant slowing of disease progression and a favorable safety profile over 18 months [1] Clinical Trial Results - The survival analysis from the PARADIGM trial showed a hazard ratio of 0.35 (p=0.0037), indicating a statistically significant reduction in the risk of death after adjusting for baseline risk factors [1] - Kaplan–Meier survival estimates indicated a median survival of 36.3 months for PrimeC compared to 21.4 months for the placebo group (log-rank p=0.0218) [1] Regulatory Engagement - NeuroSense is actively engaging with regulatory authorities to advance PrimeC towards potential marketing authorization, with preparations for a Phase 3 study underway [1]

Core Insights - NeuroSense Therapeutics announced a statistically significant 65% reduction in the risk of death and a median survival benefit of over 14 months for patients with ALS treated with PrimeC [1] Group 1: Clinical Trial Results - The updated analysis from the PARADIGM Phase 2b clinical trial shows that patients receiving PrimeC had a median survival of 36.3 months compared to 21.4 months for those on placebo, indicating a 70% increase in median survival [1] - The survival benefit was consistent over time, with a log-rank test showing statistical significance (p = 0.0218) [1] - A Cox proportional hazards model indicated that PrimeC treatment was associated with a hazard ratio of 0.35, reflecting a 65% reduction in the risk of death compared to placebo (p = 0.0037) [1] Group 2: Company Overview - NeuroSense is a late-stage clinical biotechnology company focused on developing treatments for neurodegenerative diseases, including ALS, Alzheimer's, and Parkinson's [1] - The company aims to address significant unmet medical needs in neurodegenerative diseases, which currently have limited effective therapeutic options [1] - NeuroSense's strategy involves developing combined therapies targeting multiple pathways associated with these diseases [1] Group 3: Product Information - PrimeC is NeuroSense's lead drug candidate, a novel extended-release oral formulation combining ciprofloxacin and celecoxib, designed to target mechanisms contributing to neuron degeneration and inflammation [1] - The company continues to engage with regulatory authorities to advance PrimeC into pivotal late-stage development, reinforcing the clinical and regulatory foundation for the drug [1]

Core Viewpoint - NeuroSense Therapeutics has strengthened its global intellectual property portfolio for its lead drug candidate PrimeC by securing an Australian patent, which complements an existing U.S. patent and extends exclusivity through October 2042 [1][2][3]. Group 1: Intellectual Property and Patent Strategy - The Australian Patent Office granted Australian Patent No. 2022370513 for PrimeC, which is a significant addition to NeuroSense's global patent protection strategy [1][2]. - The granted patent in Australia follows the approval of the corresponding U.S. patent (12,097,185), enhancing NeuroSense's exclusivity strategy for PrimeC across key global markets [2][3]. - CEO Alon Ben-Noon emphasized that securing patent protection in Australia is crucial for executing the company's global IP protection strategy for PrimeC, which is essential for long-term value creation [3]. Group 2: Product Development and Clinical Readiness - PrimeC is a proprietary fixed-dose oral therapy combining ciprofloxacin and celecoxib, designed to target multiple disease pathways implicated in ALS and Alzheimer's disease [3][7]. - The formulation of PrimeC allows for consistent exposure across various disease pathways, supporting a multi-target disease-modifying approach [3]. - PrimeC is now Phase 3-ready in ALS, following positive results from the Phase 2b PARADIGM trial and FDA clearance of the pivotal Phase 3 protocol [4]. Group 3: Market Context and Unmet Medical Needs - Neurodegenerative diseases, including ALS and Alzheimer's, represent significant unmet medical needs, with limited effective therapeutic options currently available [5]. - ALS affects over 5,000 people annually in the U.S., with a substantial disease burden estimated at $1 billion per year [8]. - Alzheimer's disease impacts more than 30 million people globally, characterized by memory loss and cognitive decline, with a pressing need for disease-modifying treatments [10].

Core Insights - NeuroSense Therapeutics has been granted U.S. Patent No. 12,527,768 for the use of PrimeC combination in treating Alzheimer's disease, extending patent protection through 2043, which strengthens the company's intellectual property position [1][8] - The company recently completed a proof-of-concept study for Alzheimer's disease, with top-line results indicating a favorable safety and tolerability profile, with further clinical and biomarker outcomes expected in Q1 2026 [2][8] Company Overview - NeuroSense Therapeutics is a clinical-stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, including Alzheimer's disease, amyotrophic lateral sclerosis (ALS), and Parkinson's disease, addressing significant unmet medical needs [5] - The company's lead drug candidate, PrimeC, is an extended-release oral formulation combining ciprofloxacin and celecoxib, designed to target multiple mechanisms of neurodegeneration and inflammation [4][5] Alzheimer's Disease Context - Alzheimer's disease is a leading cause of dementia, affecting over 30 million people globally, characterized by memory loss and cognitive decline, with no current cure available [3] - There is a significant unmet need for disease-modifying treatments that can slow or halt the progression of Alzheimer's disease, making approaches like PrimeC potentially impactful [3]

Core Insights - NeuroSense Therapeutics is advancing its Alzheimer's disease program and has appointed Prof. Steven E. Arnold to its Scientific Advisory Board, enhancing its scientific leadership [1][2] - The company recently completed a proof-of-concept study for Alzheimer's disease, with results indicating a favorable safety and tolerability profile, and expects clinical and biomarker outcomes in Q1 2026 [2] Company Overview - NeuroSense Therapeutics is a clinical-stage biotechnology company focused on developing treatments for severe neurodegenerative diseases, including Alzheimer's disease and ALS, addressing significant unmet medical needs [5] - The company's strategy involves developing combined therapies that target multiple pathways associated with neurodegenerative diseases, leveraging strong scientific research on biomarkers [5] Alzheimer's Disease Context - Alzheimer's disease is a leading cause of dementia, affecting over 30 million people globally, characterized by memory loss and cognitive decline, with no current cure available [3] - There is a significant unmet need for disease-modifying treatments that can slow or halt the progression of Alzheimer's disease, making multi-target approaches like PrimeC potentially valuable [3] PrimeC Drug Candidate - PrimeC is NeuroSense's lead drug candidate, an extended-release oral formulation combining two FDA-approved drugs, ciprofloxacin and celecoxib, designed to target key mechanisms of neuron degeneration and inflammation [4] - The multi-target mechanism of PrimeC is relevant to both Alzheimer's disease and ALS, aiming to inhibit disease progression [4]

Company Overview - NeuroSense Therapeutics Ltd. is a late-clinical stage biotechnology company focused on developing novel treatments for severe neurodegenerative diseases, including Alzheimer's disease (AD) and amyotrophic lateral sclerosis (ALS) [5] - The company aims to address significant unmet medical needs in neurodegenerative diseases, which currently have limited effective therapeutic options available [5] Alzheimer's Disease Insights - Alzheimer's disease is a progressive neurodegenerative disorder affecting over 30 million people globally, characterized by memory loss, cognitive decline, and behavioral changes, with no current cure available [3] - Existing therapies provide only limited symptomatic relief, highlighting the need for disease-modifying treatments that can slow or halt disease progression [3] PrimeC Drug Candidate - PrimeC is NeuroSense's lead drug candidate, an extended-release oral formulation combining two FDA-approved drugs: ciprofloxacin and celecoxib [4] - The drug is designed to target multiple mechanisms contributing to neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation, potentially inhibiting the progression of ALS and AD [4] Clinical Study Results - The safety analysis from the Phase 2 NST-AD-001 study of PrimeC in Alzheimer's disease indicated a favorable tolerability profile, with no serious adverse events or new safety signals reported [2] - Clinical outcome measures from the study are descriptive by design, and results, including biomarker data, are expected to be reported in Q1 2026 [1][2]

NeuroSense 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]