A Phase 2, Randomized, Prospective Double-Blind, Single-Center, Placebo-controlled Study to Evaluate Safety, Tolerability, Target Engagement, and Efficacy of PrimeC in Patients With Mild to Moderate Alzheimer's Disease (AD)

20 subjects with mild to moderate AD will be enrolled in the study and randomized at a 1:1 ratio to receive the study drug or placebo tablets, respectively. All subjects will be administered the drug/placebo twice daily (BID), two tablets each time, for 52 weeks.
Subjects will be allowed to receive standard of care (SOC) treatment of approved products or their combination. Subjects will be evaluated every 3 months for safety and tolerability.

开始日期2023-11-19

申办/合作机构

Neurosense Therapeutics Ltd.

NCT05436678

/ Completed临床1期

An Open Label, Randomized, Multiple-Dose, Two-Treatment, Two-Period, Two-Sequence, Crossover Study to Evaluate the Comparative Bioavailability of PrimeC (Ciprofloxacin and Celecoxib) Tablets to Ciprofloxacin Tablets Co-administered With Celecoxib Capsules, in Healthy Adult Subject

This is an open-label, randomized, multiple-dose, two-treatment, two-period crossover study comparing the test and reference products. In each period of the study, either 2 × PrimeC tablets or reference products (ciprofloxacin co-administered celecoxib) will be administered to subjects every 12 hours for 6.5 days (13 total administrations), in fed conditions.
The subjects will receive the test treatment in one of the study periods and the reference treatment in the other study period according to a two-sequence randomization schedule. Blood samples will be collected before the morning dose on Day 1, before the morning and evening dose on Days 5 and 6, before the morning dose on Day 7 and at intervals over 48 hours after the morning dose on Day 7 (see Section 7.6) in each study period. Subjects will be confined at the clinical facility from at least 10.5 hours before the initial dose on Day 1 until approximately 48 hours after the final dose on Day 7.

开始日期2022-07-26

申办/合作机构

Neurosense Therapeutics Ltd.

NCT05357950

/ Completed临床2期

A Phase IIb, Randomized, Multi-Center, Multinational, Prospective, Double-Blind, Placebo-Controlled Study, With an Open Label Extension, to Evaluate Safety, Tolerability and Efficacy of PrimeC in Subjects With ALS

69 subjects with ALS will be enrolled in the study and randomized at a 2:1 ratio to receive the study drug or placebo tablets. Randomization sequences will be in random block sizes and stratified for ENCALS risk category [high risk ≥ -4.5 vs. low risk < -4.5], and for background ALS treatment (riluzole and/or edaravone and/or sodium phenylbutyrate and/or taurursodiol) vs. no background ALS treatment.
All subjects will be administered the drug/placebo twice daily (BID), two tablets each time, for 6 months. Subjects will be allowed to receive standard of care (SOC) treatment of approved products (i.e., riluzole and edaravone). Additionally, subjects will be allowed to receive treatment with off-label sodium phenylbutyrate and taurursodiol, which are accepted for ALS treatment.
Subjects will be evaluated every 2 months for safety, tolerability (adverse events, safety laboratory, vital signs, ECG, withdrawal rates and reasons) and efficacy (e.g. biomarkers, clinical outcomes (ALSFRS-R and SVC, quality of life and survival).
All subjects who complete the 6 months dosing will be switched to the active arm for a 12-month open label extension (OLE).

开始日期2022-05-31

申办/合作机构

Neurosense Therapeutics Ltd.

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100 项与塞来昔布/环丙沙星相关的专利（医药）

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项与塞来昔布/环丙沙星相关的文献（医药）

2023-04-03·Amyotrophic lateral sclerosis & frontotemporal degeneration

Combination of ciprofloxacin/celecoxib as a novel therapeutic strategy for ALS

Article

作者: Salomon-Zimri, Shiran ; Russek-Blum, Niva ; Shefner, Jeremy M. ; Paganoni, Sabrina ; Pushett, Avital ; Ennist, David L. ; Drory, Vivian E. ; Berry, James D. ; Van Eijk, Ruben P. A. ; Beaulieu, Danielle ; Eitan, Erez ; Abramovich, Beatrice ; Birman, Nurit ; Elgrart, Katya

OBJECTIVE:

This study aimed to evaluate the safety and tolerability of a fixed-dose co-formulation of ciprofloxacin and celecoxib (PrimeC) in patients with amyotrophic lateral sclerosis (ALS), and to examine its effects on disease progression and ALS-related biomarkers.

METHODS:

In this proof of concept, open-label, phase IIa study of PrimeC in 15 patients with ALS, participants were administered PrimeC thrice daily for 12 months. The primary endpoints were safety and tolerability. Exploratory endpoints included disease progression outcomes such as forced vital capacity, revised ALS functional rating scale, and effect on algorithm-predicted survival. In addition, indications of a biological effect were assessed by selected biomarker analyses, including TDP-43 and LC3 levels in neuron-derived exosomes (NDEs), and serum neurofilaments.

RESULTS:

Four participants experienced adverse events (AEs) related to the study drug. None of these AEs were unexpected, and most were mild or moderate (69%). Additionally, no serious AEs were related to the study drug. One participant tested positive for COVID-19 and recovered without complications, and no other abnormal laboratory investigations were found. Participants' survival compared to their predictions showed no safety concerns. Biomarker analyses demonstrated significant changes associated with PrimeC in neural-derived exosomal TDP-43 levels and levels of LC3, a key autophagy marker.

INTERPRETATION:

This study supports the safety and tolerability of PrimeC in ALS. Biomarker analyses suggest early evidence of a biological effect. A placebo-controlled trial is required to disentangle the biomarker results from natural progression and to evaluate the efficacy of PrimeC for the treatment of ALS. Summary for social media if publishedTwitter handles: @NeurosenseT, @ShiranZimri•What is the current knowledge on the topic? ALS is a severe neurodegenerative disease, causing death within 2-5 years from diagnosis. To date there is no effective treatment to halt or significantly delay disease progression.•What question did this study address? This study assessed the safety, tolerability and exploratory efficacy of PrimeC, a fixed dose co-formulation of ciprofloxacin and celecoxib in the ALS population.•What does this study add to our knowledge? This study supports the safety and tolerability of PrimeC in ALS, and exploratory biomarker analyses suggest early insight for disease related-alteration.•How might this potentially impact the practice of neurology? These results set the stage for a larger, placebo-controlled study to examine the efficacy of PrimeC, with the potential to become a new drug candidate for ALS.

Pharmaceuticals

Elucidating the Synergistic Effect of the PrimeC Combination for Amyotrophic Lateral Sclerosis in Human Induced Pluripotent Stem Cell-Derived Motor Neurons and Mouse Models

Article

作者: Russek-Blum, Niva ; Salomon-Zimri, Shiran ; Kerem, Nitai ; Linares, Gabriel R. ; Ichida, Justin K. ; Tracik, Ferenc

Background: Amyotrophic lateral sclerosis (ALS) is a multifactorial neurodegenerative disease characterized by the involvement of multiple pathways and mechanisms. The complexity of its pathophysiology is reflected in the diverse hypotheses relating to its underlying causes. Given this intricate interplay of processes, a combination therapy approach offers a promising strategy. Combination therapies have demonstrated significant success in treating complex diseases, where they aim to achieve synergistic therapeutic effects and reduce drug dosage. PrimeC is an oral combination treatment composed of a patented novel formulation consisting of specific and unique doses of two well-characterized drugs (ciprofloxacin and celecoxib). It aims to synergistically inhibit the progression of ALS by addressing key elements of its pathophysiology. Objectives: Demonstrating the synergistic effect of the PrimeC combination compared to each of its individual components, celecoxib and ciprofloxacin, and assessing its ability to improve the drug concentration profile and efficacy. Methods: The efficacy of the PrimeC combination was assessed in a survival assay using human induced pluripotent stem cell (iPSC)-derived motor neurons. Additionally, a drug profiling study was conducted, measuring drug levels in the brain and serum of C57BL mice treated with a single compound versus the combination. Results: Motor neurons modeling ALS treated with the PrimeC combination exhibited better survival rates compared to treatment with either individual compound alone. The enhanced efficacy of the combination was further supported by a drug concentration profiling study in rodents, demonstrating that the PrimeC combination resulted in increased ciprofloxacin concentrations in both brain tissue and serum—highlighting the optimized interaction and synergistic potential of its two comprising agents. Conclusions: Our findings support the potential of combination therapy as an effective strategy for ALS treatment. Specifically, the PrimeC combination demonstrated promising therapeutic effects, providing a strong rationale for its ongoing development as a targeted treatment for ALS.

项与塞来昔布/环丙沙星相关的新闻（医药）

2025-12-22

·PRNewswire

NeuroSense Confirms Favorable Safety and Tolerability of PrimeC in an Alzheimer's Phase 2 Study

Clinical and Biomarker Outcomes Expected to Be Reported in Q1 2026 CAMBRIDGE, Mass., Dec. 22, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today reported completion of the safety analysis from its proof-of-concept Phase 2, randomized, double-blind, placebo-controlled NST-AD-001 study of PrimeC combination in Alzheimer's disease. The safety analysis indicated a favorable tolerability profile for PrimeC. No serious adverse events were reported, and no new or unexpected safety signals were identified. As an exploratory proof-of-concept study, clinical outcome measures are descriptive by design. NeuroSense will analyze clinical observations alongside biomarker data to enable a more comprehensive interpretation of the clinical observations, with results expected in the first quarter of 2026. About Alzheimer's Disease Alzheimer's disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting more than 30 million people globally. AD is characterized by memory loss, cognitive decline, and behavioral changes, and currently has no cure. Existing therapies provide only limited symptomatic relief, leaving a significant unmet need for disease-modifying treatments that can slow or halt progression. Given the complexity of AD, approaches that target multiple disease mechanisms simultaneously, such as PrimeC, hold potential to deliver meaningful therapeutic advances for patients and their families. 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 and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS and AD. 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. For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels. 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 timing of regulatory filings, meetings and regulatory decisions. Further, certain forward-looking statements, including statements regarding the timing of the reporting of additional data from the study of PrimeC in Alzheimer's disease, 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 uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data, including from the study of PrimeC in Alzheimer's disease; that the study will not be successful; the ability of NeuroSense to remain listed on Nasdaq; 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 April 7, 2025 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. Logo: SOURCE NeuroSense 21% more press release views with Request a Demo

临床2期临床结果

2025-10-06

·PRNewswire

NeuroSense: PrimeC Produces Statistically Significant Reductions in Alzheimer's Disease Biomarkers

CAMBRIDGE, Mass., Oct. 6, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced new positive findings based on plasma samples from its Phase-2b PARADIGM study. These results indicate that PrimeC produced robust, statistically significant reductions in multiple microRNAs that are consistently implicated in Alzheimer's disease pathology - changes that reflect reduction of neuroinflammatory and neurodegenerative activity. Key Highlights - PrimeC treatment significantly reduced several AD-associated microRNAs, including miR-146a-5p (p=0.007), miR-21-5p (p=0.003), miR-let-7a-5p (p=0.028) and miR-let-7e-5p (p=0.006), measured as change from baseline, while no significant change was observed in the placebo group over time. MicroRNAs are master regulators of gene expression. The miRNAs described above are associated with neuroinflammation, amyloid and tau pathology, synaptic dysfunction which relate to a cognitive decline. By lowering these biomarkers, PrimeC demonstrated the ability to directly target biological pathways central to AD progression, supporting its potential as a disease-modifying therapy. Alon Ben-Noon, Chief Executive Officer of NeuroSense, said: "These biomarker data provide a clearer view of how our novel combination modulates biological pathways implicated in Alzheimer's disease. The magnitude and consistency of the observed miRNA changes are highly encouraging and, together with our Phase 2 clinical findings, will inform a design of follow-on AD study, all while we continue to advance PrimeC's Phase 3 readiness program in ALS." About Alzheimer's Disease Alzheimer's disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting more than 30 million people globally. AD is characterized by memory loss, cognitive decline, and behavioral changes, and currently has no cure. Existing therapies provide only limited symptomatic relief, leaving a significant unmet need for disease-modifying treatments that can slow or halt progression. Given the complexity of AD, approaches that target multiple disease mechanisms simultaneously, such as PrimeC, hold potential to deliver meaningful therapeutic advances for patients and their families. 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 and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS and AD. About PARADIGM PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial of PrimeC in ALS. The trial included 68 participants living with ALS in Canada, Italy, and Israel. During the first 6 months of the trial, 45 participants were randomized to receive PrimeC, and 23 participants were randomized to receive placebo. This was followed by a 12-month open-label extension with all participants receiving PrimeC in a blinded manner, where neither the participants nor the clinical staff were aware of the initial treatment allocation. Most patients enrolled in both the active and placebo arms of the trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug. 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. For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels. 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 timing of regulatory filings, meetings and regulatory decisions. 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 uncertainty regarding outcomes and the timing of current and future clinical trials; timing for reporting data; the ability of NeuroSense to remain listed on Nasdaq; 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 April 7, 2025 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. Logo: SOURCE NeuroSense WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床结果

2025-09-10

·PRNewswire

NeuroSense's Drug Candidate Shows Early Signals of Benefit in Alzheimer's Patient-Derived Neurons

Initial Phase 2 RoAD trial results demonstrate improvements in brain-cell connectivity and health, with a favorable safety profile CAMBRIDGE, Mass., Sept. 10, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced positive initial results from its collaboration with NeuroKaire in the ongoing RoAD Phase 2 clinical trial evaluating PrimeC for Alzheimer's disease (AD). Using NeuroKaire's proprietary technology to generate brain cells from each patient's blood, analysis of samples from clinically characterized AD patients demonstrated that: PrimeC treatment enhanced neuroplasticity, a key feature in supporting brain health and function and underlying memory formation and retention. No treatment-related toxicity was observed, demonstrating the safety of PrimeC combination. NeuroSense's RoAD study is a randomized, double-blind, placebo-controlled Phase 2 trial enrolling mild-to-moderate AD patients, designed to evaluate safety, efficacy, and biological activity of PrimeC over 12 months. These results provide an early, patient-specific view of how PrimeC may affect disease-relevant human neurons, reinforcing the program's mechanistic rationale and guiding precision development in AD. NeuroKaire's proprietary technology reprograms blood sample cells into induced pluripotent stem cells (iPSCs) and differentiates them into mature human cortical neurons. After validation, neurons are exposed to PrimeC, and advanced high-content imaging using AI-driven analytics quantifies key features of neuronal structure. This generates composite response profiles tied to neuroplasticity, connectivity, and cell health. Alon Ben-Noon, CEO of NeuroSense, stated: "This is exactly the kind of early, decision-enabling signal RoAD was designed to uncover. By integrating NeuroKaire's patient-derived neuron platform with our clinical program, we observed measurable gains in brain-cell connectivity and a favorable safety profile. These findings strengthen PrimeC's mechanistic rationale in Alzheimer's and enable us to focus development with greater precision." Dr. Daphna Laifenfeld, CSO of NeuroKaire, commented: "Our platform is designed to detect subtle, disease-relevant changes in human neurons with the sensitivity modern drug development requires. This collaboration demonstrates how a bench-to-clinic 360° workflow can transform a simple blood draw into actionable, patient-specific insights, accelerating innovation for people living with AD." These results will be presented at the CNS Summit 2025 in Boston, November 2nd – 5th by David Pattison, VP Business Development at NeuroKaire. NeuroSense and NeuroKaire will continue evaluating PrimeC's cellular effects in parallel with clinical outcomes from the RoAD trial, with top-line data expected following study completion. About Alzheimer's Disease Alzheimer's disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia worldwide, affecting more than 30 million people globally. AD is characterized by memory loss, cognitive decline, and behavioral changes, and currently has no cure. Existing therapies provide only limited symptomatic relief, leaving a significant unmet need for disease-modifying treatments that can slow or halt progression. Given the complexity of AD, approaches that target multiple disease mechanisms simultaneously, such as PrimeC, hold potential to deliver meaningful therapeutic advances for patients and their families. 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 and AD, that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid ("RNA") regulation to potentially inhibit the progression of ALS and AD. About NeuroKaire NeuroKaire, founded in 2018 by Talia Cohen-Solal, Ph.D., and Daphna Laifenfeld, Ph.D., is developing personalized medicine solutions to optimize treatment for psychiatric and neurological diseases. The company's proprietary AI-powered platform, Stemifai, leverages stem cell differentiation and machine learning to inform and advance CNS drug development processes. To learn more, follow us on LinkedIn or on Twitter @Genetikaplus. 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. For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels. 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 results of the ongoing RoAD Phase 2 clinical trial evaluating PrimeC for Alzheimer's disease (AD). 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 final results of the ongoing RoAD Phase 2 clinical trial evaluating PrimeC for Alzheimer's disease (AD) will not be consistent with its positive initial results, the risk of a delay in submission by the Company of its regulatory dossier, that regulatory approvals for PrimeC will be delayed or not obtained in Canada or elsewhere; unexpected R&D costs or operating expenses, insufficient capital to complete development of PrimeC, a delay in the reporting of additional results from PARADIGM clinical trial, the timing of expected regulatory and business milestones, risks associated with meeting with the FDA and Health Canada to determine the best path forward following the results from PARADIGM clinical trial, including a delay in any such meeting; 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 Neurosense; the ability of NeuroSense to remain listed on Nasdaq; 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 April 4, 2024 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. Logo: SOURCE NeuroSense WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期临床结果

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适应症	最高研发状态	国家/地区	公司	日期
阿尔茨海默症	临床2期	以色列	Neurosense Therapeutics Ltd.	2023-11-19
肌萎缩侧索硬化	临床2期	以色列	Neurosense Therapeutics Ltd.	2019-11-25

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05357950 (PARADIGM, NEWS) 人工标引	临床2期	肌萎缩侧索硬化	39	PrimeC	顧鹹繭醖獵壓鑰鏇鬱憲(觸廠廠鬱糧壓築艱繭鏇): Difference (%) = 29 更多	积极	2025-03-01
				Placebo
NCT05357950 (PARADIGM, SFN2024)	临床2期	肌萎缩侧索硬化 TDP43 \| PGJ2 \| Neurofilament light chain (NfL) ... 更多	69	PrimeC	繭觸網觸鑰遞憲蓋製糧(鬱淵遞繭窪鹹淵鹽壓廠) = 選膚鬱觸窪積簾範顧構製鏇積構積鏇憲網醖構 (構糧簾廠膚鹹蓋觸淵淵, 0.337 ~ 6.1) 更多	积极	2024-10-07
				Placebo	繭觸網觸鑰遞憲蓋製糧(鬱淵遞繭窪鹹淵鹽壓廠) = 觸鏇艱鑰鑰糧繭選廠淵製鏇積構積鏇憲網醖構 (構糧簾廠膚鹹蓋觸淵淵, -0.6 ~ 5.07) 更多
NCT05357950 (PARADIGM, PRNewswire) 人工标引	临床2期	肌萎缩侧索硬化	68	PrimeC	顧鏇壓醖廠夢網餘鹽壓(獵願糧窪簾膚齋壓選製) = These positive changes in iron metabolism align with improved clinical outcomes. Patients on PrimeC maintained better functionality and survival rates compared to those on placebo. 製膚選構選淵醖製鹹築 (襯壓廠鑰廠衊醖齋鹽窪 ) 更多	积极	2024-08-01
				Placebo
NCT05357950 (PARADIGM, PRNewswire) 人工标引	临床2期	肌萎缩侧索硬化	-	PrimeC	餘膚簾鹽獵憲選範廠構(艱積選鏇衊餘遞網顧壓) = 壓夢製繭範窪構鏇窪衊廠窪膚製鬱鹽繭窪窪壓 (鏇夢鹽襯鬱製獵鹽齋鏇 ) 更多	积极	2024-07-03
				Placebo	-
NCT05357950 (PARADIGM, PRNewswire) 人工标引	临床2期	肌萎缩侧索硬化	68	PrimeC	糧餘膚蓋襯範願鏇鑰鬱(簾齋觸顧積網襯選範鹽) = PrimeC achieved an improvement in complication-free survival compared to placebo (in several methodologies, including MiToS and King's Advanced Stage-free Survival), reducing the risk of ALS disease complications or death by up to 53%. 鹽願膚窪窪壓壓積鑰糧 (顧鹹繭鏇糧遞鬱積衊鑰 )	积极	2024-02-21
				Placebo
NCT05357950 (PARADIGM, Biospace) 人工标引	临床2期	肌萎缩侧索硬化	68	PrimeC	廠繭範夢獵鹹觸鹽淵餘(鹽鏇餘遞鏇選憲範夢糧) = The safety and tolerability profile of PrimeC was comparable to the placebo. 壓構範膚餘鑰製壓顧鬱 (觸願構憲築觸夢遞夢醖 ) 更多	积极	2023-12-05
				placebo
ASCO2005	临床1期	非小细胞肺癌	15	Celecoxib	鬱簾憲齋鹽願窪壓繭糧(製顧選餘膚齋蓋窪衊齋) = 艱醖獵網構簾齋選蓋憲顧憲餘鏇顧鹽糧積構糧 (廠膚壓築蓋鏇餘襯網廠 )	-	2005-06-01
				Erlotinib	鬱簾憲齋鹽願窪壓繭糧(製顧選餘膚齋蓋窪衊齋) = 築襯選窪壓鑰繭夢顧膚顧憲餘鏇顧鹽糧積構糧 (廠膚壓築蓋鏇餘襯網廠 )