NeuroSense Therapeutics reported that its Phase 2b PARADIGM trial of PrimeC in amyotrophic lateral sclerosis (ALS) has produced new long‑term survival data, showing a 65% reduction in the risk of death for patients who received PrimeC continuously compared with those who began on placebo and crossed over to active treatment. The updated analysis reports a median overall survival of 36.3 months for patients who received PrimeC throughout both the double‑blind and open‑label phases, versus 21.4 months for the crossover group. This 14‑month improvement represents a 70% increase in median survival and was statistically significant (log‑rank p = 0.0218, Cox model hazard ratio 0.35, 95% CI 0.17–0.71, p = 0.0037).
The PARADIGM study enrolled 68 patients and evaluated PrimeC, a fixed‑dose combination of ciprofloxacin and celecoxib, in a randomized, double‑blind, placebo‑controlled design followed by an open‑label extension. The hazard ratio of 0.35 indicates that continuous PrimeC treatment reduced the risk of death by 65% relative to the crossover group, and the 95% confidence interval (0.17–0.71) confirms the precision of the estimate. The statistical significance of the log‑rank test (p = 0.0218) and the Cox model (p = 0.0037) demonstrate that the survival benefit is unlikely to be due to chance.
CEO Alon Ben‑Noon said, "The long‑term survival data further validate the magnitude and durability of PrimeC's effect in ALS and reinforce its potential as a disease‑modifying therapy. 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. We believe these findings substantially strengthen the clinical and regulatory foundation as we advance toward late‑stage development." The data support NeuroSense’s strategy to move PrimeC into a multinational Phase 3 ALS study and to engage regulators with a robust evidence base.
PrimeC’s intellectual‑property portfolio has expanded with new patents in the United States and Australia, extending protection through 2042/2043. The company is also developing PrimeC for Alzheimer’s disease, broadening its therapeutic pipeline. The survival data reinforce the company’s multi‑targeted approach and provide a strong foundation for future regulatory submissions and potential accelerated approval pathways.
NeuroSense remains a clinical‑stage company with a significant accumulated deficit and ongoing cash burn. The company’s most recent earnings, for Q3 2024, reported an EPS of –$0.11 versus analyst expectations of –$0.16, and the next earnings report is expected around February 24, 2026. To support the upcoming Phase 3 trial, the company has sought shareholder approval to increase its registered share capital, providing flexibility for future financing. The new survival data, while not a financial result, are a critical milestone that will shape the company’s valuation and funding strategy moving forward.
The 65% mortality reduction and 14‑month median survival gain represent a landmark achievement for PrimeC and for ALS treatment. The data strengthen the case for a pivotal Phase 3 trial, enhance the company’s regulatory prospects, and expand its intellectual‑property moat. As NeuroSense prepares to launch the next development phase, the survival benefit will be a key metric for investors, regulators, and patients alike.
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