NeuroSense Reports New Data: Statistically Significant Clinical Efficacy in Phase 2b ALS Trial

• A statistically significant, 37.4% difference (P=0.03), slowing of disease progression in ALSFRS-R, in patients treated with PrimeC compared to placebo, in the pre-specified Per Protocol (PP) population analysis
• Neurofilament biomarker results from Biogen collaboration expected in January 2024
• Primary biomarker endpoints, TDP-43 and Prostagladin2, are expected in H1 2024
• PrimeC’s meaningful effect magnitude, strong safety profile, and unique mechanism of action will be discussed with the FDA and other regulatory agencies in an End of Phase 2 meeting in H1 2024

Excerpt from the Press Release:

CAMBRIDGE, Mass., Dec. 14, 2023 /PRNewswire/ — NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense”), a company developing treatments for severe neurodegenerative diseases, today reported additional positive efficacy data from further evaluation of its Phase 2b trial (PARADIGM) with NeuroSense’s lead drug candidate for amyotrophic lateral sclerosis (“ALS”), PrimeC.

Evaluation of the pre-specified Per Protocol (PP) population analysis of the recent top-line results from PARADIGM revealed a statistically significant slowing of disease progression with a 37.4% (p=0.03) difference in the gold standard ALS tracking measure, the ALS Functional Rating Scale-Revised (“ALSFRS-R”), in favor of PrimeC vs placebo, and 17.2% (p=0.39) difference in Slow Vital Capacity (“SVC”), in favor of PrimeC vs placebo. The PP analysis population includes all participants who adhered to the trial protocol and treatment plan without any major protocol deviations. The goal of a PP analysis in clinical trials is to assess the efficacy of a treatment under optimal conditions, thereby providing a clearer understanding of how well the treatment works when implemented as intended, contributing to a more comprehensive view of the trial results.  PARADIGM’s PP population analysis is pre-defined in the trial’s statistical analysis plan, which includes 62 patients (43 active and 19 placebo) compared to 68 patients in the Intent to Treat (ITT) population (45 active and 23 placebo).

PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial. The trial’s primary endpoints include: safety and tolerability, and ALS-related biomarkers TDP-43 and Prostagladin2. The trial’s secondary endpoints include: clinical efficacy outcome measures, ALSFRS-R and SVC. ALSFRS-R is the most widely used ALS tracking tool accepted by the FDA, utilized by neurologists treating ALS patients, in clinical trials, and by other regulators to determine disease progression. It tracks 12 changes in a person’s physical abilities over time including functions such as: speech, walking, climbing stairs, dressing/hygiene, handwriting, turning in bed, cutting food, salivation, swallowing, and breathing. SVC is a measurement of respiratory function.

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