Presentation will highlight how findings from the PARADIGM program are informing the clinical development strategy for PARAGON
CAMBRIDGE, Mass., Oct. 29, 2026 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense" or the "Company"), a biotechnology company developing treatments for neurodegenerative diseases, today announced that its clinical and biomarker findings informing the next phase of PrimeC's development will be presented at the 2026 Annual Meeting of the Northeast Amyotrophic Lateral Sclerosis (NEALS) Consortium in Clearwater, Florida.
The presentation, titled "From PARADIGM to PARAGON: Converging Clinical and Biomarker Findings Informing Phase 3 Development of PrimeC," is scheduled for Friday, October 30, at 11:25 a.m. Eastern Time.
The presentation will highlight how clinical and biomarker findings from the PARADIGM Phase 2b program are shaping PARAGON, NeuroSense's planned Phase 3 study of PrimeC in ALS, supporting a rigorous and more efficient approach to clinical development.
It will be co-presented by Prof. Merit Cudkowicz, MD, MSc, Director of the Sean M. Healey & 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.
About NeuroSense
NeuroSense Therapeutics is a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and Alzheimer's disease. The Company's lead product candidate, PrimeC, is a novel oral therapy designed to target multiple key biological pathways underlying disease progression, including neuroinflammation, oxidative stress and dysregulated iron metabolism.
NeuroSense has recently completed analysis of long-term follow-up data from its Phase 2b PARADIGM study in ALS, with results published in JAMA Neurology showing slower functional decline in participants who received PrimeC from study start than in those who initially received placebo. The Company also reported changes across multiple biomarkers associated with ALS, including microRNAs, consistent with PrimeC's multi-target mechanism of action.
NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate its pivotal Phase 3 clinical trial (PARAGON) in ALS, to be conducted primarily in the United States. The Company is working with FDA on an optimized design for the study.
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About PrimeC
PrimeC, NeuroSense's lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to target several key mechanisms that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation, with the potential to inhibit disease progression.
About ALS
Amyotrophic lateral sclerosis ("ALS") is an incurable neurodegenerative disease that causes progressive paralysis and, typically, death within 3 years of symptoms onset. 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.
Forward-Looking Statements
This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on NeuroSense Therapeutics' current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the Company's development program, including for ALS and TBI, the potential issuance, scope and duration of patent protection arising from the Company's patent application, including expected protection through 2047, subject to any extensions, the potential of PrimeC to treat TBI and related central nervous system injuries, the potential expansion of PrimeC beyond ALS and its potential commercial benefits and long-term value. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. These risks include the risk that the patent application will not result in an issued patent or that any patent granted will not provide the Company with the anticipated scope or duration of protection or will be challenged, invalidated or unenforceable; the risk that PrimeC will not demonstrate safety or efficacy in TBI or related conditions; the potential for delay in the timing of the Phase 3 clinical trial (PARAGON) in ALS; the risk that the Company will not be able to obtain financing on acceptable terms, or at all; the risk that the Company will not regain and maintain compliance with the Nasdaq listing requirements; the risk that non-dilutive grant funding for the PARAGON trial will not be awarded or will be delayed; uncertainty regarding outcomes and the timing of current and future clinical trials; the risk that PrimeC will not advance towards later-stage development; timing for reporting data, including from the study of PrimeC in Alzheimer's disease; that the study will not be successful; and other risks and uncertainties set forth in NeuroSense's filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2026 and NeuroSense's subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.
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