NeuroSense reports 65% death risk reduction in ALS trial

NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) announced extended survival data from its completed PARADIGM Phase 2b clinical trial of PrimeC in patients with amyotrophic lateral sclerosis. The analysis showed a statistically significant 65% reduction in the risk of death for patients receiving 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 a median survival of 36.3 months, compared to 21.4 months for patients initially assigned to placebo. This represents a 14.9-month improvement in median survival.

A log-rank test comparing survival curves demonstrated statistical significance with a p-value of 0.0218. Cox proportional hazards model analysis showed PrimeC treatment was associated with a hazard ratio of 0.35 (95% CI: 0.17-0.71; p = 0.0037) after adjusting for baseline risk factors.

The PARADIGM Phase 2b trial was a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of PrimeC in 68 people with ALS. Participants received PrimeC or placebo at a 2:1 ratio for six months during the double-blind phase.

"A 65% reduction in the risk of death and a statistically significant extension in median survival of over 14 months represent a clinically meaningful benefit of notable magnitude in ALS," said CEO Alon Ben-Noon.

PrimeC is an extended-release oral formulation combining ciprofloxacin and celecoxib, both FDA-approved drugs. The company continues to engage with regulatory authorities regarding advancement into pivotal late-stage development.

NeuroSense previously reported positive results from the trial, including statistically significant slowing of disease progression. The newly reported survival findings represent additional data from the same completed study.

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