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Presentation by Massachusetts General Chair of Neurology Merit Cudkowicz, MD, shows both positive clinical effects and consistent trend toward impact on Neurofilament biomarker levels
CAMBRIDGE, Mass., April 18, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a company developing novel treatments for severe neurodegenerative diseases, announces the presentation of data from the Company's PARADIGM Phase 2b study of PrimeC during an Emerging Science session (equivalent to Late Breaker) at the American Academy of Neurology Annual Meeting, which validates the previously announced topline data. In addition to the positive clinical outcomes, the study also demonstrated a positive trend toward impact on Neurofilament (NfL) levels.
The presentation, titled, "PrimeC, An Oral Candidate for Amyotrophic Lateral Sclerosis, Meets Primary and Secondary Endpoints in the Phase 2b PARADIGM Trial," was presented yesterday as an Emerging Science presentation by Merit Cudkowicz, M.D., M.Sc., chair of neurology and Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital. The study showed that PrimeC, a novel formulation of specific doses of ciprofloxacin and celecoxib, met safety and tolerability measures as well as statistically significant slowing of disease progression as demonstrated by the ALSFRS-R by 37% (p=0.03) in the per-protocol population. Further, the data showed supporting trends in biomarkers, specifically Neurofilament.
Alon Ben-Noon, CEO of NeuroSense commented, "It is gratifying that these data have been validated by the prestigious American Academy of Neurology and presented by Dr. Cudkowicz. We look forward to continued work with PrimeC for ALS and believe that there is a significant opportunity to provide a potential new approach to address this devastating disease."
NeuroSense Therapeutics, Ltd. is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. NeuroSense believes that these diseases, which include amyotrophic lateral sclerosis (ALS), Alzheimer's disease and Parkinson's disease, among others, represent one of the most significant unmet medical needs of our time, with limited effective therapeutic options available for patients to date. Due to the complexity of neurodegenerative diseases and based on strong scientific research on a large panel of related biomarkers, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.
For additional information, please visit the Company's website and follow NeuroSense on LinkedIn and X (Twitter).
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 PrimeC as a potential treatment for people with ALS. 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 unexpected R&D costs or operating expenses, the timing of expected regulatory and business milestones, inability to retain the listing of the Company's ordinary share on Nasdaq, risks associated with meeting with the FDA to determine the best path forward following the results from PARADIGM clinical trial, including a delay in any such meeting, a delay in patient enrollment for a Phase 2 trial for Alzheimer's disease; the potential for PrimeC to safely and effectively target AD; preclinical and clinical data for PrimeC; the uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the development and commercial potential of any product candidates of the company; 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 the Company is contained under the heading "Risk Factors" in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on April 4, 2024. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense Therapeutics Ltd. undertakes no duty to update such information except as required under applicable law.
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