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NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) is a clinical-stage biotechnology company focused on discovering and developing treatments for patients suffering from debilitating neurodegenerative diseases. These diseases encompass Amyotrophic Lateral Sclerosis (ALS), Alzheimer's disease, and Parkinson's disease, among others.
The company's flagship product, PrimeC, is a novel extended-release oral formulation, combining ciprofloxacin and celecoxib in a specific ratio designed for synergistic effect. PrimeC aims to target several key mechanisms of ALS, including motor neuron degeneration, inflammation, iron accumulation, and impaired RNA regulation. The formulation has shown promising results in clinical trials, including a significant slowing of disease progression in Phase 2b studies.
In their recent PARADIGM Phase 2b clinical trial, NeuroSense demonstrated compelling data with a 37% reduction in the progression of ALS, with further subgroup analysis showing even higher efficacy in specific patient populations. This trial's success propelled the company towards preparing for a Phase 3 pivotal trial, with extensive collaboration and validation from industry experts.
NeuroSense has been active in forming strategic partnerships to enhance its research and development capabilities. Notable collaborations include agreements with Lonza for biomarker development, and Genetika+ for Alzheimer's disease drug development. These partnerships leverage cutting-edge technologies to optimize clinical outcomes and advance the company's therapeutic solutions.
Financially, NeuroSense reported an increase in R&D expenses from $6.4 million in 2022 to $7.6 million in 2023, reflecting its investment in expanding its workforce and clinical programs. Conversely, general and administrative expenses saw a decrease, contributing to an efficient allocation of resources. As of December 31, 2023, the company had a cash position of approximately $2.6 million.
With multiple ongoing projects and a robust pipeline, NeuroSense is set to play a significant role in addressing the unmet medical needs in neurodegenerative diseases. The company's dedication to advancing research and developing novel therapies positions it as a key player in biotech innovation.
For more information, visit NeuroSense's investor relations website at https://neurosense.investorroom.com/.
NeuroSense Therapeutics (NASDAQ: NRSN) announced that Dr. Shiran Zimri will present findings related to PrimeC at the AD/PD 2023 Conference in Gothenburg, Sweden, from March 28 - April 1, 2023. PrimeC is currently in Phase 2b trials for ALS, with topline results anticipated in H2 2023. Initial studies show PrimeC's efficacy in improving ALS-related biomarkers and tolerability. Additionally, a Phase 2 proof-of-concept study for Alzheimer's Disease is set to commence in H1 2023, focusing on the combined therapeutic strategy using ciprofloxacin and celecoxib, which may show promise in treating AD based on biomarker detections.
NeuroSense Therapeutics (Nasdaq: NRSN) announced its annual report for 2022, showcasing significant developments in its clinical trials and financials. The company is advancing its lead candidate PrimeC for ALS, with over 50% patient enrollment in the Phase 2b PARADIGM trial, expected to report topline results in H2 2023. Positive preliminary findings from a biomarker study in Alzheimer's disease prompted plans for a Phase 2 trial in H1 2023. However, R&D expenses surged by 108% to $6.4 million, and general administrative costs increased by 185% to $7.1 million, reflecting expanding operational activities. Cash reserves stood at $7.1 million.
NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) announced participation in the 17th annual BIO-Europe Spring conference on March 20-22, 2023 in Basel, Switzerland. Chief Medical Officer Dr. Ferenc Tracik and VP of Business Development Nedira Salzman-Frenkel will meet potential partners regarding the company's drug development pipeline. NeuroSense's lead drug, PrimeC, is in a global Phase 2b study for ALS, with results expected in H2 2023. Other programs include Alzheimer's and Parkinson's disease treatments, with key milestones expected in 2023.
NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) will participate in Renmark Financial Communications' Virtual Non-Deal Roadshow Series on March 21, 2023, at 11:00 AM PST, and March 28, 2023, at 10:00 AM EST. The sessions will feature CEO Alon Ben-Noon and VP Nedira Salzman-Frenkel, focusing on the latest investor presentation and a live Q&A. Interested investors can register for the events, with limited spots available. Replays will be accessible later on the company's investor website. NeuroSense is dedicated to developing treatments for neurodegenerative diseases, addressing significant unmet medical needs in this area.
NeuroSense Therapeutics (NASDAQ: NRSN) recently shared a corporate update highlighting growth opportunities for 2023. The company anticipates topline results from its Phase 2b clinical trial in amyotrophic lateral sclerosis (ALS) in H2 2023, with enrollment already over 50% complete across four countries. Additionally, promising Alzheimer's disease biomarker results were announced, leading to a planned Phase 2 study in the first half of 2023. A Parkinson's disease biomarker study is also ongoing, with results expected soon. CEO Alon Ben-Noon expressed optimism about the company’s performance in 2022 and future milestones.
NeuroSense Therapeutics (NASDAQ: NRSN) has announced a collaboration with QuantalX Neuroscience to utilize Delphi-MD, a neurodiagnostic technology, in their upcoming Phase 2 clinical trial for Alzheimer's disease (AD). This trial is expected to commence in H1 2023 and aims to enhance early diagnosis and treatment of neurodegenerative diseases. Delphi-MD will provide objective measurements of brain function, supporting improved patient care. The partnership also anticipates using this technology in a future Phase 3 trial for PrimeC, NeuroSense's lead drug candidate for ALS treatment, pending successful Phase 2b trial results.
NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) announced regulatory approval from Germany's BfArM for its Clinical Trial Application to enroll patients in the PARADIGM study, a Phase 2b trial for PrimeC in treating amyotrophic lateral sclerosis (ALS). The study is set to include participants from Israel, Italy, Canada, and Germany, with over 50% of the 69 planned patients already enrolled. Topline results are anticipated in the second half of 2023. PrimeC combines two FDA-approved drugs aimed at addressing several mechanisms involved in ALS progression. The drug has previously met safety and efficacy endpoints in Phase 2a trials.
NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) has received regulatory approval from Health Canada to initiate patient enrollment in its Phase 2b PARADIGM study for the treatment of amyotrophic lateral sclerosis (ALS) using its novel combination therapy, PrimeC. Over 50% of patients are already enrolled, with topline results expected in the second half of 2023. Following FDA's request for additional non-clinical data, NeuroSense has withdrawn its study protocol from the U.S. Investigational New Drug application and plans to align its strategy for a potential pivotal Phase 3 trial. PrimeC, a fixed-dose combination of ciprofloxacin and celecoxib, aims to target ALS progression effectively.
NeuroSense Therapeutics (NASDAQ: NRSN) has reported positive results from a biomarker study evaluating its combination therapy for Alzheimer's disease (AD). The study found elevated levels of TDP-43, a novel biomarker, in AD patients compared to healthy controls. NeuroSense plans to expand the study to further validate these findings and anticipates starting a Phase 2 double-blind proof-of-concept clinical trial in the first half of 2023. TDP-43's relevance in AD is highlighted by its association with cognitive impairment severity, presenting potential for NeuroSense's therapy in addressing significant unmet medical needs in neurodegenerative diseases.
NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) reported its Q3 2022 financial results, highlighting notable milestones in its Phase 2b ALS study. The FDA accepted NeuroSense's IND, allowing for patient enrollment in the U.S. and Italy. As of September 30, 2022, the company had $8.4 million in cash and short-term deposits, sufficient to fund operations into Q4 2023. R&D expenses rose to $4.87 million from $3.04 million year-over-year, while general and administrative expenses increased to $5.30 million. The company expects steady expenses through 2022.
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