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NeuroSense Therapeutics Ltd. Reports Promising ALS Treatment Findings in Form 6-K

$NRSN
Form 6-K
Filed on: 2025-02-19
Source
NeuroSense Therapeutics Ltd. Reports Promising ALS Treatment Findings in Form 6-K

Here are the key insights extracted from the financial report of NeuroSense Therapeutics Ltd.:

  1. Report Overview:
  • Type: Form 6-K, which is a report of a foreign private issuer.
  • Date of Report: February 19, 2025.
  • Company: NeuroSense Therapeutics Ltd.
  • Commission File Number: 001-41084.
  • Address: 11 HaMenofim Street, Building B, Herzliya 4672562, Israel.
  1. Clinical Study Findings:
  • NeuroSense has reported additional findings from its Phase 2b PARADIGM study evaluating PrimeC for the treatment of Amyotrophic Lateral Sclerosis (ALS).
  • The study duration was 18 months, with initial results previously reported focusing on ALSFRS-R (ALS Functional Rating Scale-Revised) and overall survival.
  1. New Data Presented:
  • The report includes data from predefined Per Protocol outcomes and two additional endpoints: Complication-free survival and Slow Vital Capacity (SVC).
  1. Endpoints and Results:
  • ALSFRS-R:
    • Per Protocol: 39% improvement (p = 0.001).
    • Intent to Treat: 33% improvement (p = 0.007).
  • Overall Survival:
    • Per Protocol: 74% survival (p = 0.02).
    • Intent to Treat: 58% survival (p = 0.11).
  • Complication-Free Survival:
    • Per Protocol: 79% (p < 0.001).
    • Intent to Treat: 64% (p = 0.02).
  • Slow Vital Capacity:
    • Per Protocol: 26% (p = 0.1).
    • Intent to Treat: 19% (p = 0.22).
  1. Conclusion on Treatment Impact:
  • The data indicates a positive impact of PrimeC compared to placebo, suggesting its potential efficacy in ALS treatment.
  1. Regulatory Filing:
  • The report is intended to be incorporated by reference into the company's registration statements on Form S-8 and Form F-3, affirming its ongoing regulatory obligations.
  1. Management Signature:
  • Signed by Alon Ben-Noon, Chief Executive Officer, on February 19, 2025.

This report highlights significant clinical trial results that could have implications for the therapeutic use of PrimeC in ALS, as well as the company's commitment to regulatory compliance.