NeuroSense Reveals Statistically Significant Data from PARADIGM ALS Treatment Study

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NeuroSense announced further data from its PARADIGM Phase 2b study.¹ The new data was derived from a 12-month analysis of the data collected during the study, which evaluated the effectiveness of PrimeC in people with Amyotophic Lateral Schlerosis (ALS).

According to the company, the data shows a statisitically significant improvement in the rate of decline of ALSFRF-R scores and survival rates of subjects who took PrimeC compared to the placebo group. The group receiving the medicine reportedly saw an average improvement of 36%.

Merit Cudkowicz, MD, MSc, is the chair of neurology and director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital. In a press release, they said, “These exciting long-term results demonstrate how study participants experienced more slowing of progression over time with PrimeC as measured against ALSFRS-R, which is the current gold-standard scale used in ALS drug development. The need for new treatments for people living with ALS has never been greater. PrimeC has great potential based on its mode of action and the phase 2 trial results and warrants further evaluation in a Phase 3 trial in an expeditious manner."

In the same press release, Vivian Drory, MD, head of the ALS clinic at Tel-Aviv Sourasky Medical Center, also said, “The promising results from the 12-month PARADIGM study highlight the significant potential of PrimeC as a disease-modifying drug for ALS. These findings underscore the importance of early intervention, which can lead to more substantial benefits, and provide valuable insights that will inform the design of the Company's Phase 3 study, increasing the likelihood of success."

NeuroSense previously announced results from the same study back in May of this year.² At the time, the company reported that PrimeC had slowed the disease progression by 43% in certain high-risk ALS patients.

In a press release issued at the time, professor of neurology at the Barrow Neurological Institute in Phoenix, Arizona, Jeremy M. Shefner, MD, PhD, said, “The impressive results of these new analyses raise further enthusiasm for the potential impact of PrimeC on people with ALS. With the magnitude of its effect and consistency across subgroups, PrimeC, if approved following a Phase 3 trial, could significantly improve the standard of care for people with ALS.”

Shefner also serves as an advisor to NeuroSense.

NeuroSense's CEO Alon Ben-Noon also said, “We believe this is one of the most compelling results seen to-date in an advanced, double-blind clinical trial in ALS, demonstrating slowing the progression of ALS in patients in earlier stages with an aggressive disease.Seeing PrimeC's significant impact in the general PARADIGM population in all various clinical aspects, and even more in multiple sub-groups on the gold-standard ALSFRS-R, is truly gratifying, and we are looking forward to analyzing and reporting on the 12-month study survival data in the next few weeks."

Source

1. NeuroSense Demonstrates Statistically Significant Efficacy and Survival Benefits in People Living with ALS: The Promising Results from the 12-Month PARADIGM Study Highlight PrimeC's Potential as a Disease Modifying Drug. NeuroSense. July 1, 2024. https://www.prnewswire.com/news-releases/neurosense-demonstrates-statistically-significant-efficacy-and-survival-benefits-in-people-living-with-als-the-promising-results-from-the-12-month-paradigm-study-highlight-primecs-potential-as-a-disease-modifying-drug-302186838.html
2. NeuroSense Announces New Positive Data Analysis from PARADIGM Clinical Trial Demonstrating Statistically Significant Slowing of Disease Progression in High-Risk ALS Patients. NeuroSense. May 7, 2024. Accessed on July 1, 2024. https://www.prnewswire.com/news-releases/neurosense-announces-new-positive-data-analysis-from-paradigm-clinical-trial-demonstrating-statistically-significant-slowing-of-disease-progression-in-high-risk-als-patients-302137999.html