NeuroSense Releases Long-Term Survival Data from ALS Clinical Trial
NeuroSense Therapeutics announced the availability of additional long-term survival data from its previously completed PARADIGM Phase 2b clinical trial evaluating PrimeC in patients with amyotrophic lateral sclerosis, or ALS. The updated analysis, based on extended follow-up, demonstrates a clinically meaningful and statistically significant improvement in overall survival for patients treated with PrimeC, compared to those initially assigned to placebo. According to Kaplan-Meier survival estimates, patients who received PrimeC continuously during both the double-blind and open-label phases achieved an estimated median survival of 36.3 months, compared to 21.4 months for patients initially assigned to placebo during the double-blind phase and crossing over to active treatment during the open label extension. This represents over 14-month improvement and approximately a 70% increase in median survival. The survival benefit was sustained over time, with consistent separation between treatment arms throughout the follow-up period. The PARADIGM Phase 2b trial was a randomized, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of PrimeC in 68 people living with ALS. Participants were administered PrimeC or placebo at a 2:1 ratio, respectively, for the six-month double-blind part. NeuroSense continues to engage with regulatory authorities regarding the advancement of PrimeC into pivotal late-stage development and believes these findings add important long-term clinical context to previously reported efficacy results.
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- Clinical Data Presentation: Dr. Christian Lunetta, Chief Medical Officer of NeuroSense, will present new clinical and biomarker data on PrimeC at the 2026 AD/PD International Conference, highlighting its potential in ALS treatment and likely attracting significant attention from the scientific community.
- PARADIGM Trial Findings: The presentation will review key findings from the Phase 2b PARADIGM trial, which provide an important scientific foundation for the design of the global Phase 3 PARAGON trial, potentially accelerating the path to market authorization for PrimeC.
- ALS Disease Burden: Over 5,000 people are diagnosed with ALS annually in the U.S., with the number of patients expected to grow by 24% by 2040, underscoring NeuroSense's strategic importance in addressing this significant unmet medical need.
- Global Trial Plans: The PARAGON Phase 3 trial is planned as a multinational, randomized, double-blind, placebo-controlled study designed to further evaluate PrimeC's potential to slow disease progression in ALS patients, demonstrating NeuroSense's commitment to advancing innovative therapeutic options.
- Clinical Trial Results: NeuroSense's PARADIGM Phase 2b trial results indicate that the PrimeC treatment group achieved a 7.92-point improvement in functional scores over 18 months, representing over a 36% slowdown in disease progression, laying a solid foundation for further Phase 3 trials.
- Biomarker Changes: The trial observed significant improvements in iron metabolism biomarkers, including the preservation of transferrin levels and stabilization of ferritin, indicating PrimeC's effectiveness in modulating ALS-related biological pathways.
- Safety and Tolerability: The study results demonstrated good safety for PrimeC, with multiple clinical endpoints consistently suggesting potential clinical benefits, thereby enhancing confidence in its role as a disease-modifying therapy.
- Future Development Plans: NeuroSense has received FDA clearance to proceed with a Phase 3 trial aimed at validating PrimeC's impact on ALS patients, further advancing its clinical development trajectory.
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- Significant Survival Improvement: The recently reported long-term survival data from the Phase 2b PARADIGM trial shows that PrimeC achieves a 65% reduction in the risk of death (hazard ratio: 0.35; p=0.0037) and offers a median survival benefit of over 14 months (36.3 months vs. 21.4 months; log-rank p=0.0218), providing a hopeful outlook for ALS treatment.
- Clinical Data Presentation: This data will be presented by ALS research expert Dr. Jinsy Andrews at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference on March 9, 2026, further reinforcing PrimeC's clinical efficacy and safety in ALS treatment.
- Regulatory Progress Acceleration: With the release of long-term survival data, NeuroSense is actively engaging with regulatory authorities to advance PrimeC toward potential marketing authorization, marking a strategic advancement in the ALS treatment landscape.
- Market Potential: Over 5,000 new ALS diagnoses occur annually in the U.S., with an expected 24% increase in patients by 2040, presenting a significant market opportunity for NeuroSense's PrimeC, especially in the context of limited effective treatment options currently available.
- Significant Survival Improvement: In the PARADIGM Phase 2b trial, ALS patients treated with PrimeC achieved a median survival of 36.3 months, compared to 21.4 months for the placebo group, representing over a 14-month improvement and approximately a 70% increase in survival, highlighting PrimeC's potential in ALS treatment.
- Statistical Significance Confirmed: The log-rank test for survival curves yielded a p-value of 0.0218, indicating a statistically significant difference in survival between the PrimeC and placebo groups, further validating the clinical efficacy of PrimeC.
- Risk Reduction Notable: Analysis using a Cox proportional hazards model revealed that PrimeC treatment was associated with a 65% reduction in the risk of death (hazard ratio: 0.35), providing strong support for its potential as a disease-modifying therapy that could transform ALS patient treatment outcomes.
- Broad Clinical Development Prospects: NeuroSense is actively engaging with regulatory authorities to advance PrimeC into pivotal late-stage development, with the new survival data adding important long-term clinical context that enhances its competitive position in the market.
- Global IP Expansion: NeuroSense has secured Australian Patent No. 2022370513, further enhancing global intellectual property protection for PrimeC, with patent coverage extending through 2042, demonstrating the company's strategic positioning in key markets.
- Support from US Patent: The grant of this patent follows the approval of US Patent 12,097,185, indicating that NeuroSense's intellectual property protection strategy is progressing steadily in critical markets, thereby strengthening its competitive edge.
- PrimeC Drug Development: PrimeC is a fixed-dose oral therapy combining ciprofloxacin and celecoxib, designed to combat ALS and Alzheimer's disease through a multi-target mechanism, showcasing its potential in clinical stages.
- Addressing Market Demand: With the number of ALS patients expected to grow by 24% by 2040, NeuroSense's IP protection and the development of PrimeC will help meet the increasing market demand, driving long-term value creation.











