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NeuroSense Presents Positive Data Validating Phase 2b Topline Readout During Emerging Science Presentation at the American Academy of Neurology Annual Meeting

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NeuroSense Therapeutics presents positive data validating Phase 2b topline readout during an Emerging Science presentation at the American Academy of Neurology Annual Meeting. The PARADIGM study of PrimeC for Amyotrophic Lateral Sclerosis showed positive clinical effects and a trend towards impacting Neurofilament biomarker levels. PrimeC demonstrated safety, tolerability, and a 37% slowing of disease progression in the per-protocol population.
NeuroSense Therapeutics presenta dati positivi che convalidano il resoconto principale della Fase 2b durante una presentazione di Emerging Science all'incontro annuale dell'American Academy of Neurology. Lo studio PARADIGM di PrimeC per la Sclerosi Laterale Amiotrofica ha mostrato effetti clinici positivi e una tendenza all'impatto sui livelli del biomarcatore dei Neurofilamenti. PrimeC ha dimostrato sicurezza, tollerabilità e un rallentamento del 37% della progressione della malattia nella popolazione per protocollo.
NeuroSense Therapeutics presenta datos positivos que validan los resultados principales de la Fase 2b durante una presentación de Ciencia Emergente en la Reunión Anual de la Academia Americana de Neurología. El estudio PARADIGM de PrimeC para la Esclerosis Lateral Amiotrófica mostró efectos clínicos positivos y una tendencia hacia la afectación de los niveles del biomarcador de Neurofilamentos. PrimeC demostró ser seguro, tolerable y logró una desaceleración del 37% en la progresión de la enfermedad en la población por protocolo.
NeuroSense Therapeutics가 미국 신경학 아카데미 연례 회의의 Emerging Science 발표에서 2b상 탑라인 결과를 검증하는 긍정적인 데이터를 발표했습니다. 근위축성 측색 경화증에 대한 PrimeC의 PARADIGM 연구는 긍정적인 임상 효과와 신경 섬유소 바이오마커 수준에 영향을 미칠 수 있는 경향을 보였습니다. PrimeC는 안전성, 내약성을 입증하였으며, 프로토콜 대상 인구에서 질병 진행을 37% 늦추는 것으로 나타났습니다.
NeuroSense Therapeutics présente des données positives validant les résultats préliminaires de la phase 2b lors d'une présentation sur la Science Émergente à la réunion annuelle de l'Académie Américaine de Neurologie. L'étude PARADIGM de PrimeC pour la Sclérose Latérale Amyotrophique a montré des effets cliniques positifs et une tendance à influencer les niveaux du biomarqueur de Neurofilament. PrimeC a démontré une sécurité, une tolérabilité et un ralentissement de 37% de la progression de la maladie dans la population respectant le protocole.
NeuroSense Therapeutics präsentiert positive Daten, die das Topline-Ergebnis der Phase 2b während einer Emerging Science-Präsentation auf der Jahrestagung der American Academy of Neurology validieren. Die PARADIGM-Studie von PrimeC zur amyotrophen Lateralsklerose zeigte positive klinische Effekte und einen Trend zur Beeinflussung der Neurofilament-Biomarker-Ebenen. PrimeC bewies Sicherheit, Verträglichkeit und eine 37%ige Verlangsamung des Krankheitsfortschritts in der per-Protokoll-Population.
Positive
  • Positive clinical outcomes from the PARADIGM Phase 2b study of PrimeC for ALS
  • Statistically significant slowing of disease progression by 37% in the per-protocol population
  • Validation of topline data by the American Academy of Neurology
  • Positive trend towards impacting Neurofilament biomarker levels
  • Safety and tolerability of PrimeC demonstrated
  • Presentation by Dr. Merit Cudkowicz at the AAN Annual Meeting
  • Potential new approach for addressing ALS
Negative
  • None.

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.

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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."

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, 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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SOURCE NeuroSense

FAQ

What study did NeuroSense present data from at the AAN Annual Meeting?

NeuroSense presented data from the PARADIGM Phase 2b study of PrimeC for Amyotrophic Lateral Sclerosis.

Who presented the data at the Emerging Science session?

The data was presented by Dr. Merit Cudkowicz, Chair of Neurology at Massachusetts General Hospital.

What positive effects were shown in the study?

The study demonstrated positive clinical outcomes and a 37% slowing of disease progression in the per-protocol population.

What biomarker levels showed a positive trend?

Neurofilament biomarker levels showed a positive trend towards impact.

What is the name of the novel formulation studied?

The novel formulation studied is PrimeC, which consists of specific doses of ciprofloxacin and celecoxib.

What did the CEO of NeuroSense comment on the data presentation?

The CEO, Alon Ben-Noon, expressed gratification at the validation of the data by the American Academy of Neurology and the potential new approach for addressing ALS.

What institution is Dr. Merit Cudkowicz affiliated with?

Dr. Merit Cudkowicz is affiliated with Massachusetts General Hospital.

What percentage of disease progression was slowed in the per-protocol population?

Disease progression was slowed by 37% in the per-protocol population.

What was the title of the presentation at the AAN Annual Meeting?

The presentation was titled 'PrimeC, An Oral Candidate for Amyotrophic Lateral Sclerosis, Meets Primary and Secondary Endpoints in the Phase 2b PARADIGM Trial'.

What is the ticker symbol for NeuroSense Therapeutics ?

The ticker symbol for NeuroSense is NRSN.

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advancing research, development and therapy for als. neurosense therapeutics is a biotech company focusing on the development of mirnas as a novel treatment for als. currently preparing for a first clinical study in patients in usa