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NeuroSense Therapeutics Ltd., a biotechnology company concentrating on developing treatments for neurodegenerative conditions, has recently released compelling long-term survival data from its completed PARADIGM Phase 2b clinical trial assessing PrimeC for amyotrophic lateral sclerosis (ALS).
This extended analysis confirms a clinically significant and statistically robust improvement in overall survival for patients treated with PrimeC when compared to those initially receiving a placebo. The results underscore PrimeC’s potential as a genuinely disease-modifying therapy in the challenging landscape of ALS treatment.
Substantial Gains in Patient Survival
The Kaplan–Meier survival estimates drawn from the extended follow-up are particularly noteworthy. Patients who maintained continuous treatment with PrimeC through both the initial double-blind period and the subsequent open-label extension achieved an estimated median survival of 36.3 months. In stark contrast, patients who were initially on placebo during the double-blind phase and then transitioned to active treatment during the open-label extension reached a median survival of 21.4 months.
This difference translates to an impressive median survival improvement exceeding 14 months—an approximate 70% increase in median survival time. Furthermore, the survival advantage demonstrated by the PrimeC group remained consistent and separated clearly from the placebo group throughout the entire follow-up duration, signaling a durable effect.
Statistical Validation
The statistical analysis strongly supports these findings. A log-rank test comparing the survival curves yielded a statistically significant result (p = 0.0218). More profoundly, subsequent analysis utilizing a Cox proportional hazards model indicated that PrimeC treatment was associated with a substantial 65% reduction in the risk of death compared to the placebo group (hazard ratio: 0.35; 95% CI: 0.17–0.71; p = 0.0037), even after adjusting for baseline patient risk factors.
Industry Reaction and Next Steps
Alon Ben-Noon, CEO of NeuroSense, emphasized the importance of these results: “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 PARADIGM Phase 2b trial was a meticulously designed, randomized, double-blind, placebo-controlled study involving 68 individuals living with ALS. Participants received PrimeC or placebo in a 2:1 ratio over the six-month double-blind period. NeuroSense had previously shared positive top-line results showing statistically significant slowing of disease progression alongside favorable safety and tolerability profiles. These newly reported survival metrics add critical, long-term clinical context to the existing efficacy data package.
NeuroSense is actively engaging with regulatory bodies concerning the progression of PrimeC into pivotal late-stage development, confident that this robust survival data will significantly support their regulatory filings.
About NeuroSense and PrimeC
NeuroSense Therapeutics is committed to addressing debilitating neurodegenerative diseases like ALS, Alzheimer’s disease, and Parkinson’s disease, where effective treatments are critically lacking. Their strategy centers on developing combination therapies that target multiple interconnected disease pathways, leveraging strong biomarker research.
PrimeC, the company’s leading candidate, is an innovative, extended-release oral formulation. It combines two existing FDA-approved drugs—ciprofloxacin and celecoxib—in a fixed-dose combination. This formulation is engineered to simultaneously address several core mechanisms driving degeneration in ALS and AD, including inflammation, impaired RNA regulation, iron accumulation, and neuron degeneration, with the goal of inhibiting disease progression.
ALS remains a devastating, incurable condition, typically leading to complete paralysis and death within 2 to 5 years of diagnosis. In the U.S. alone, over 5,000 new diagnoses occur annually, with the patient population expected to grow significantly by 2040.