Additional long-term survival data from the previously concluded PARADIGM Phase 2b clinical trial assessing PrimeC in patients with amyotrophic lateral sclerosis (ALS) have been made available by NeuroSense Therapeutics Ltd., a late-stage clinical biotechnology company dedicated to creating disease-modifying treatments for neurodegenerative diseases.
When comparing patients treated with PrimeC to those initially randomized to a placebo, the new data, which is based on extended follow-up, shows a clinically relevant and statistically significant improvement in overall survival.
Patients who received PrimeC continuously during both the double-blind and open-label phases had an estimated median survival of 36.3 months, according to Kaplan–Meier survival estimates. This is in contrast to patients who were initially assigned to a placebo during the double-blind phase and switched to active treatment during the open-label extension, who had an estimated median survival of 21.4 months. This indicates a median survival gain of about 70% and an improvement of more than 14 months. With constant separation between treatment arms over the follow-up period, the survival effect persisted over time.
A comparison of survival curves using a log-rank test revealed statistical significance (p = 0.0218).
After controlling for baseline risk factors, additional analysis using a Cox proportional hazards model revealed that PrimeC therapy was linked to a 65% lower risk of mortality when compared to placebo (hazard ratio: 0.35; 95% CI: 0.17–0.71; p = 0.0037).
“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,” stated Alon Ben-Noon, CEO of NeuroSense. “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 purpose of the randomized, double-blind, placebo-controlled PARADIGM Phase 2b trial was to assess PrimeC’s safety and effectiveness in 68 ALS patients. During the six-month double-blind phase, participants received either PrimeC or a placebo at a 2:1 ratio. Positive top-line outcomes from the trial, such as a statistically significant slowing of disease progression and excellent safety and tolerability, were previously published by NeuroSense. The recently released survival results add to the data set supporting PrimeC by providing further significant information derived from the same finished trial.
Regarding PrimeC’s progression into crucial late-stage development, NeuroSense is still in contact with regulatory bodies. The company thinks these results provide significant long-term clinical context to previously published efficacy findings.
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