NeuroSense Reports Statistically Significant Survival Benefit In ALS Phase 2b PARADIGM Study; 50% Of PrimeC Patients Remain Alive

Author: Benzinga Newsdesk | September 04, 2025 08:12am

NeuroSense Therapeutics Ltd. (the "Company") Reports Additional Clinical Data from its Phase 2b PARADIGM Study

 

More than three years from initiation of the Phase 2b PARADIGM Study, survival analyses from the largest study site of the study located in Israel, which enrolled 44 patients (approximately two-thirds of all participants in the study) and began enrollment nearly one year earlier than the other study sites, resulting in the longest follow-up and the most mature survival dataset of the study to date, demonstrated a substantial difference in survival rates between the treatment arms:

 

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50% (15/30) of participants originally randomized to PrimeC remain alive;

 

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Approximately 7% (1/14) of participants originally randomized to placebo remain alive.

 

This outcome represents a more than seven-fold survival advantage for patients treated with PrimeC, a difference that achieved statistical significance (p=0.007, Fisher's exact test).

 

These results highlight the potential of PrimeC to meaningfully extend survival in ALS, a disease with urgent unmet need and limited therapeutic options.

 

Among the surviving participants, 12 of those originally randomized to PrimeC remain ventilation-free, compared with only 1 participant originally randomized to placebo.

 

The Company continues to generate and analyze long-term clinical data to provide supportive evidence for regulatory submissions, including with Health Canada, as part of its global development and commercialization strategy.

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