NeuroSense Announces First Quarter 2024 Business Update

CAMBRIDGE, Mass., May 2, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing novel treatments for severe neurodegenerative diseases, today provides a business update.

Corporate Highlights from Q1 2024 and To Date

• Merit Cudkowicz, M.D., M.Sc., chair of neurology and Director of the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital presented full data update from PARADIGM in ALS during Emerging Sciences (late-breaker equivalent) presentation at the American Academy of Neurology annual meeting
• Announced collaboration with Genetika+ to apply their precision medicine methodology to better quantify neuronal plasticity as part of the Company's ongoing Phase 2 Alzheimer's disease trial
• Entered into collaboration with Lonza (SIX: LONN) to identify exosome-based biomarkers to further advance PrimeC in ALS
• Company announced subsequent analyses of quality of life and complication free survival from the PARADIGM Study, which demonstrated positive results as well as positive trends of key biomarker outcome of neurofilament light chain (NfL) levels

"The first several months of 2024 have proven to be very productive for NeuroSense as we have entered into multiple key collaborations that we expect will help to enhance the development of PrimeC both for ALS and Alzheimer's disease. In addition, our PARADIGM results received significant validation when they were accepted as late breaking data at the AAN conference," stated NeuroSense CEO Alon Ben-Noon. "We were honored to have Dr. Merit Cudkowicz present the data to a wide scientific audience, and we believe that these data will continue to be welcomed in the medical community as providing encouragement in the search for viable ALS treatment." 

"As we proceed through the second quarter, we anticipate further collaborations as well as to schedule an end of Phase 2 study with FDA in order to continue this important research into a Phase 3 clinical trial. We look forward to providing additional new data from the PARADIGM trial," concluded Mr. Ben-Noon.

About ALS

Amyotrophic lateral sclerosis (ALS) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 patients are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of patients with ALS is expected to grow 24% by 2040 in the U.S. and EU.

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 synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS. NeuroSense completed the 6-month double blind portion of PARADIGM, a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b ALS (NCT05357950) clinical trial, which met its safety and tolerability endpoints, as well as showing a statistically significant slowing of disease progression in the pre-specified Per Protocol (PP) population. PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency.

About NeuroSense

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.

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 NeuroSense's collaborations and PrimeC as a potential treatment for people with ALS and the timing for release of additional results from PARADIGM clinical trial. 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 NeuroSense will not enter into other collaborations, that the existing collaborations will not will help to enhance the development of PrimeC, unexpected R&D costs or operating expenses, unanticipated reactions in the medical community to the results of the PARADIGM clinical trial, a delay in the reporting of additional results from PARADIGM clinical trial, the timing of expected regulatory and business milestones, including an end of Phase 2 study with FDA, 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 in the planned Phase 3 pivotal ALS trial of PrimeC; the potential for PrimeC to safely and effectively target ALS; 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; the ability to regain compliance with Nasdaq's continued listing standards; 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 3, 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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SOURCE NeuroSense