NeuroSense: PrimeC Shows 18-Month ALS Efficacy in New Analysis
Ticker: NRSNW · Form: 6-K · Filed: Sep 2, 2025 · CIK: 1875091
Sentiment: bullish
Topics: clinical-trial-results, drug-development, neurology, als
TL;DR
NeuroSense's PrimeC shows statistically significant ALS slowing at 18 months in Phase 2b PARADIGM study.
AI Summary
NeuroSense Therapeutics Ltd. announced on September 2, 2025, a new analysis of 18-month data from its Phase 2b PARADIGM study of PrimeC for ALS. The analysis showed a statistically significant effect (p=0.03) using an NfL-adjusted MMRM analysis, with a 28% relative difference in ALSFRS-R decline favoring patients who received PrimeC from the study's start.
Why It Matters
This data suggests PrimeC may offer a meaningful benefit in slowing ALS progression, potentially impacting treatment strategies for this devastating disease.
Risk Assessment
Risk Level: medium — While the results are promising, they are from a Phase 2b study and require further validation in larger trials.
Key Numbers
- 18-month — Data analysis period (Duration of the analyzed data from the PARADIGM study.)
- p=0.03 — Statistical significance (Indicates a statistically significant effect in the analysis.)
- 28% — Relative difference in decline (Favored patients receiving PrimeC, indicating potential efficacy.)
Key Players & Entities
- NeuroSense Therapeutics Ltd. (company) — Registrant
- PrimeC (drug) — Investigational drug for ALS
- ALS (disease) — Disease being studied
- PARADIGM (study) — Phase 2b clinical trial name
- September 2, 2025 (date) — Announcement date
- 18-month (duration) — Data analysis period
- p=0.03 (statistical_value) — Statistical significance level
- ALSFRS-R (metric) — Functional rating scale for ALS
FAQ
What specific statistical analysis was used for the 18-month data?
An NfL-adjusted MMRM (Mixed Model for Repeated Measures) analysis was used.
What was the primary outcome measure showing a statistically significant effect?
The ALS Functional Rating Scale-Revised (ALSFRS-R) decline showed a statistically significant effect.
What is the name of the Phase 2b study where this data was collected?
The study is named PARADIGM.
What is the investigational drug being studied?
The investigational drug is PrimeC.
When was this announcement made?
The announcement was made on September 2, 2025.
Filing Stats: 328 words · 1 min read · ~1 pages · Grade level 14.3 · Accepted 2025-09-02 08:36:01
Filing Documents
- ea0255499-6k_neurosense.htm (6-K) — 12KB
- 0001213900-25-082945.txt ( ) — 13KB
SIGNATURES
SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. NeuroSense Therapeutics Ltd. Date: September 2, 2025 By: /s/ Alon Ben-Noon Alon Ben-Noon Chief Executive Officer 2