NeuroSense Announces New Data Analysis From PARADIGM Clinical Trial Demonstrating Statistically Significant Slowing Of Disease Progression In High-Risk ALS Patients; PrimeC Slowed Disease Progression By 43% In Pre-Specified High-Risk ALS Patients
- PrimeC slowed disease progression by 43% (p=0.02) in pre-specified high-risk ALS patients
- Consistent data across subgroups underscore the potential of PrimeC to redefine the ALS treatment paradigm
CAMBRIDGE, Mass., May 7, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) ("NeuroSense"), a company developing novel treatments for severe neurodegenerative diseases, announces new analyses from its Phase 2b PARADIGM clinical trial, demonstrated a statistically significant slowing of disease progression in high-risk ALS patients treated with PrimeC by 43% (p=0.02) as compared to placebo in the pre-specified per protocol (PP) population analysis after 6 months of treatment. The slowing of disease progression demonstrated by PrimeC versus placebo translates to a 5.04 points difference in the ALSFRS-R in favor of PrimeC (Confidence Interval: 0.862, 9.214; n=38).
High-risk patients, defined by the European Network for the Cure of ALS (ENCALS) Risk Factor as those with a higher risk for rapid disease progression, comprise approximately 50% of the total ALS population.
"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," commented Jeremy M. Shefner M.D., Ph.D., Professor of Neurology at the Barrow Neurological Institute, Phoenix, Ariz., and a NeuroSense advisor.
In addition to the subgroup of high-risk patients, patients treated with PrimeC who had symptoms for up to 12 months prior to the baseline visit (newly diagnosed patients), showed a 52% slowing of disease progression (p=0.008) versus placebo in the PP population analysis. This translates to a 7.76-point difference in the ALSFRS-R in favor of PrimeC (Confidence Interval: 2.27, 13.25; n=22). These subgroup analyses provide data suggesting consistent, statistically significant effect of PrimeC on the range of participants within the PARADIGM study.
In the Intent-to-treat (ITT) population, high-risk ALS patients treated with PrimeC experienced a 31% (p=0.13) reduction in disease progression, which translates to a 3.2 points difference in the ALSFRS-R in favor of PrimeC (Confidence Interval: -1.03, 7.43; n=41). In addition, in the group of participants who had symptoms for up to 12 months prior to l the baseline visit (newly diagnosed patients) experienced a 36% reduction (p=0.14), which translates to a 4.56-point difference in the ALSFRS-R in favor of PrimeC (Confidence Interval: -1.6, 10.72; n=25).
Additional results of the subgroup analysis of the effect of PrimeC versus placebo on ALSFRS-R showed:
- Participants with a disease duration of up to 18 months (PP analysis), PrimeC demonstrated a 38% change (p=0.054)
- Participants with a disease duration of up to 24 months (PP analysis), PrimeC demonstrated 37% reduction in symptom scores (p=0.047)
The Company plans to utilize these subgroup analyses to help inform the design of the upcoming pivotal trial, which the Company believes will increase its probability of success and its cost-effectiveness.
Alon Ben-Noon, NeuroSense's CEO commented, "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."
About ALS
Amyotrophic lateral sclerosis ("ALS") is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.