NeuroSense reports positive results from its ALS trial 

NeuroSense Therapeutics has reported additional positive data from its six-month double-blind Phase IIb PARADIGM trial of its lead drug candidate PrimeC for the treatment of amyotrophic lateral sclerosis (ALS).  

The PARADIGM trial’s secondary clinical efficacy outcome measure endpoints included Quality of Life and Survival. Consistent with the previously reported results, PrimeC displayed a clinically meaningful effect on various aspects of patients’ quality of life, including mental and physical health.  

Moreover, analyses pertaining to survival outcomes emphasised the implications of PrimeC intervention in mitigating disease progression and burden. 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%. These survival analyses observe time from participant randomisation 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 hospitalisation 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,” stated Ferenc Tracik, NeuroSense’s Chief Medical Officer. “From a clinical perspective, these parameters are crucial to neurologists, but more importantly to people living with ALS.” 

This news comes on the heels of the recent positive top-line results reported in December 2023 from the PARADIGM trial in 68 participants, which met its primary endpoint of safety and tolerability, establishing a robust safety profile of PrimeC. In addition, 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 (ALSFRS-R), in favour of PrimeC vs placebo, and 17.2% difference in Slow Vital Capacity (SVC) in favour of PrimeC vs placebo, based on the pre-specified Per Protocol (PP) population analysis. The PP analysis population includes all participants who adhered to the trial protocol and treatment plan without any major protocol deviations and includes 62 patients (43 active and 19 placebo).  

“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,” stated Alon Ben-Noon, NeuroSense’s CEO. 

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