NeuroSense Reports Additional Positive Results from Phase IIb ALS Clinical Trial

Image Credit: © Egor - stock.adobe.com

NeuroSense Therapeutics has announced the reporting of additional positive data from its Phase IIb PARADIGM trial of NeuroSense's lead drug candidate PrimeC for the treatment of amyotrophic lateral sclerosis (ALS), according to a company press release.¹

The six-month double-blind trial trial's secondary clinical efficacy outcome measure endpoints included quality of life and survival. The most recent results show PrimeC displayed a clinically meaningful effect on various aspects of patients' quality of life, including mental and physical health.

According to an estimate from the Centers for Disease Control and Prevention, there are over 31,000 patients living with ALS in the United States as of 2017. On average 5,000 new patients are diagnosed with ALS every year.²

PrimeC achieved an improvement in complication-free survival compared to placebo (in several methodologies, including MiToS and King's Advanced Stage-free Survival), reducing the risk of ALS disease complications or death by up to 53%, according to the press release. These survival analyses observe time from participant randomization to death from any cause or respiratory insufficiency (defined as tracheostomy or the use of non-invasive mechanical ventilation for over 22 hours per day for 10 or more consecutive days), or time to hospitalization due to ALS-related complications or advancements in MiToS or King's stages.

"PrimeC's demonstrated positive effect on quality of life and survival, aligned with the already positive clinical outcome measures, in a relatively small Phase IIb clinical trial truly demonstrates its potential to deliver a meaningful benefit," said Ferenc Tracik, MD, chief medical officer, NeuroSense in the press release. "From a clinical perspective, these parameters are crucial to neurologists, but more importantly to people living with ALS."

In December 2023, NeuroSense reported positive results from the PARADIGM trial in 68 participants, which met its primary endpoint of safety and tolerability for PrimeC. Additionally, PrimeC demonstrated a statistically significant slowing of disease progression with a 37.4% difference in the gold standard ALS tracking measure, the ALS Functional Rating Scale-Revised.

"The positive impact of PrimeC on quality of life and complication-free survival, together with its demonstrated ability to meaningfully slow down disease progression, is of great value, as we see that we have the potential to profoundly affect patients' lives across the board. We are in great anticipation to soon report on the status of our collaboration on neurofilaments and how this may contribute to expediting the development of PrimeC," said Alon Ben-Noon, CEO of NeuroSense in the press release.

References

1. NeuroSense Reports Additional Positive Results from its ALS Phase 2b PARADIGM Trial. News release. February 21, 2024. Accessed February 22, 2024. https://www.prnewswire.com/news-releases/neurosense-reports-additional-positive-results-from-its-als-phase-2b-paradigm-trial-302067299.html
2. Amyotrophic lateral sclerosis. Centers for Disease Control and Prevention, U.S. Department of Health & Human Services. Accessed January 23, 2024. https://www.cdc.gov/als/WhatisALS.html