NeuroSense Therapeutics Ltd. issued a press release on October 29, 2026, announcing that clinical and biomarker findings from its PARADIGM Phase 2b program will be presented at the 2026 Annual Meeting of the Northeast ALS Consortium in Clearwater, Florida, on October 30, 2026.

Key Highlights

  • Presentation date and time: Scheduled for Friday, October 30, at 11:25 a.m. Eastern Time at the 2026 NEALS Consortium Annual Meeting in Clearwater, Florida.
  • Presentation title: "From PARADIGM to PARAGON: Converging Clinical and Biomarker Findings Informing Phase 3 Development of PrimeC."
  • Co-presenters: Prof. Merit Cudkowicz, MD, MSc, Director of the Sean M. Healey and AMG Center for ALS at Massachusetts General Hospital and Julieanne Dorn Professor of Neurology at Harvard Medical School, and Dr. Shiran Zimri, PhD, Vice President of R&D and Country Lead, Canada, at NeuroSense.
  • PARADIGM results: According to the filing, long-term follow-up data from the Phase 2b PARADIGM study showed slower functional decline in participants who received PrimeC from study start than in those who initially received placebo, with results published in JAMA Neurology.
  • Phase 3 clearance: The company disclosed it has received clearance from the U.S. Food and Drug Administration to initiate its pivotal Phase 3 clinical trial, PARAGON, in ALS, to be conducted primarily in the United States.
  • PrimeC composition: The filing describes PrimeC as an extended-release oral formulation combining two FDA-approved drugs: ciprofloxacin and celecoxib.

PARADIGM Findings Shape NeuroSense's Planned Phase 3 PARAGON Trial

NeuroSense Therapeutics Ltd. (NASDAQ:NRSN), a biotechnology company focused on neurodegenerative disease treatments, announced on October 29, 2026, that data from its PARADIGM Phase 2b program will be shared at the 2026 NEALS Consortium Annual Meeting. According to the filing, the presentation will highlight how clinical and biomarker findings from PARADIGM are shaping PARAGON, the company's planned Phase 3 study of PrimeC in ALS, "supporting a rigorous and more efficient approach to clinical development."

The company disclosed that its completed analysis of long-term follow-up data from the PARADIGM study showed slower functional decline in participants who received PrimeC from study start compared to those who initially received placebo. The company also reported changes across multiple biomarkers associated with ALS, including microRNAs, which the filing states are "consistent with PrimeC's multi-target mechanism of action." These results were published in JAMA Neurology, according to the filing.

PrimeC is described in the filing as a novel extended-release oral formulation composed of a fixed-dose combination of ciprofloxacin and celecoxib, two FDA-approved drugs, designed to target neuroinflammation, oxidative stress, and dysregulated iron metabolism. The company disclosed it is currently working with the FDA on an optimized design for the PARAGON Phase 3 trial, which is to be conducted primarily in the United States. The filing contains forward-looking statements, which NeuroSense cautions are subject to substantial risks and uncertainties, including potential delays in the PARAGON trial and uncertainty regarding clinical outcomes.

What Was Disclosed

NeuroSense Therapeutics announced the presentation of PrimeC clinical and biomarker data from its PARADIGM Phase 2b study at the 2026 NEALS Annual Meeting, outlining how those findings are informing the design of its planned Phase 3 PARAGON trial in ALS.