CAMBRIDGE, Mass., Feb. 24, 2022 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced that Dr. Shiran Zimri, the Company's Head of Scientific Programs, will deliver a presentation titled "Breaking the Paradigm – PrimeC as a Novel Approach to ALS Therapy" at the American Society for Experimental Neurotherapeutics (ASENT) 2022 Annual Meeting on Thursday, March 3, 2022. NeuroSense, together with Amylyx Pharmaceuticals, and the National Institute of Neuroscience in Tokyo, will co-lead a session titled "Not a One-Trick Pony: Repurposing Established Drugs for New Neurological Indications" during which Dr. Zimri will present.

NeuroSense's lead drug candidate PrimeC is a novel formulation consisting of specific doses of two FDA-approved drugs designed to work synergistically to treat amyotrophic lateral sclerosis (ALS), an incurable neurodegenerative disease that causes complete paralysis and ultimately death within 2 to 5 years from diagnosis.

"Our proprietary combination therapy approach using two well-established drugs to treat a disease as complex as ALS not only breaks the current paradigm of focusing on one target, it also potentially enables a faster path to market," Dr. Zimri commented. "With a well-established safety profile, the combination therapy's efficacy is focused on three targets: regulating microRNA synthesis, modulating iron accumulation, and attenuating neuroinflammation, and has achieved meaningful outcomes in clinical and preclinical studies to date."

PrimeC successfully met its primary endpoints in a Phase 2a trial including safety, reduced functional and respiratory deterioration, and significant changes in ALS-related biomarkers.  NeuroSense expects to commence a Phase 2b ALS study in H1 2022, with a Phase 3 study slated for H2 2023.

"With only two FDA approved treatments that have a mild effect on prolonging and improving quality of life, ALS is a devastating disease in dire need of an effective treatment. NeuroSense's PrimeC, as a proprietary combination of two FDA approved drugs, is well suited for rapid advancement through late-stage trials. We are pleased that Dr. Zimri will have the opportunity to present the potential of PrimeC to ALS thought leaders at ASENT 2022," stated NeuroSense CEO Alon Ben-Noon.

About ASENT

ASENT 2022, which will take place virtually from February 28 to March 3, 2022, is the premier neurotherapeutics conference where senior executives from leading payers, providers, employers, academic institutions, investors, fast-growing startups, pharma, policymakers, advocate organizations, funders and innovation centers in the neurology and neuroscience space gather to ask one question: How can we improve the process of bringing neurotherapeutics to market?

ASENT is an independent non-profit organization established in 1997 by leaders in academia, government, advocacy, and industry to facilitate the process by which new therapies are made available to patients with neurological disorders. Its primary goal is to encourage and advance the development of novel and improved therapies for diseases and disorders of the nervous system.

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 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, NeuroSense's strategy is to develop combined therapies targeting multiple pathways associated with these diseases.

NeuroSense completed a Phase 2a clinical study with 15 ALS patients in 2021. In this study, PrimeC was given in an intermediate formulation for 12 months to all of the patients. The study results showed meaningful clinical outcomes along with ALS related biological markers that were significantly changed, indicating a biological activity of PrimeC. NeuroSense plans to initiate a Phase 2b study, double-blind, placebo controlled, multicentered in Israel and the US in the first half of 2022 to evaluate the final formulation of PrimeC. PrimeC is a novel extended-release formulation composed of unique doses of two FDA-approved drugs, which aim to synergistically inhibit the progression of ALS. PrimeC has received orphan drug status from the FDA and EMA.

In addition, NeuroSense has recently announced the third stage of its collaboration with Massachusetts General Hospital in Boston on novel Neuron-Derived Exosomes (NDEs) to determine further the biological changes in ALS related pathologies and the effect of PrimeC on the relevant targets.

NeuroSense is also advancing programs in Alzheimer's disease and Parkinson's disease, and is aiming to initiate clinical studies in these indications in the first half of 2023.

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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 participation in conferences; the company's PrimeC development program; the potential for PrimeC to safely and effectively target ALS; preclinical and clinical data for PrimeC; the timing of current and future clinical trials; the nature, strategy and focus of the company and further updates with respect thereto; and the development and commercial potential of any product candidates of the company. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. 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