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NeuroSense Therapeutics Announces Acceptance of Two PrimeC Abstracts at the 2024 NEALS Annual Meeting

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NeuroSense Therapeutics announced the acceptance of two abstracts focusing on their lead drug candidate, PrimeC, for Amyotrophic Lateral Sclerosis (ALS) treatment at the 2024 Annual Northeastern ALS Consortium Meeting. The abstracts will present data from NeuroSense's Phase 2b PARADIGM study.

Dr. Merit Cudkowicz from Massachusetts General Hospital will present clinical outcomes, while Dr. Cristian Lunetta from NEMO in Milan will discuss biomarker analysis. Recent findings showed PrimeC reduced disease progression by 36% (p=0.009) and improved survival rates by 43% compared to placebo, highlighting its potential as a breakthrough ALS therapy.

NeuroSense Therapeutics ha annunciato l'accettazione di due abstract incentrati sul loro principale candidato terapeutico, PrimeC, per il trattamento della sclerosi laterale amiotrofica (SLA) durante la Conferenza Annuale del Consorzio ALS del Nord-Est 2024. Gli abstract presenteranno dati dello studio PARADIGM di Fase 2b di NeuroSense.

La Dr.ssa Merit Cudkowicz del Massachusetts General Hospital presenterà i risultati clinici, mentre il Dr. Cristian Lunetta di NEMO a Milano discuterà l'analisi dei biomarcatori. Risultati recenti hanno mostrato che PrimeC ha ridotto la progressione della malattia del 36% (p=0.009) e migliorato i tassi di sopravvivenza del 43% rispetto al placebo, evidenziando il suo potenziale come terapia innovativa per la SLA.

NeuroSense Therapeutics anunció la aceptación de dos resúmenes centrados en su principal candidato a fármaco, PrimeC, para el tratamiento de la esclerosis lateral amiotrófica (ELA), en la Reunión Anual del Consorcio ALS del Noreste 2024. Los resúmenes presentarán datos del estudio PARADIGM de Fase 2b de NeuroSense.

La Dra. Merit Cudkowicz del Massachusetts General Hospital presentará los resultados clínicos, mientras que el Dr. Cristian Lunetta de NEMO en Milán discutirá el análisis de biomarcadores. Hallazgos recientes mostraron que PrimeC redujo la progresión de la enfermedad en 36% (p=0.009) y mejoró las tasas de supervivencia en 43% en comparación con el placebo, destacando su potencial como una terapia innovadora para la ELA.

NeuroSense Therapeutics는 2024년 북동부 ALS 컨소시엄 회의에서 근위축성 측삭 경화증(ALS) 치료를 위한 주요 약물 후보인 PrimeC에 관한 두 개의 초록이 수용되었다고 발표했습니다. 초록에서는 NeuroSense의 2b 단계 PARADIGM 연구의 데이터를 발표할 것입니다.

매사추세츠 종합병원의 Merit Cudkowicz 박사가 임상 결과를 발표할 예정이며, 밀라노의 NEMO 소속 Cristian Lunetta 박사가 바이오마커 분석에 대해 논의할 것입니다. 최근 연구 결과에 따르면 PrimeC는 질병 진행률을 36% 감소시키고(p=0.009) 위약과 비교하여 생존율을 43% 향상시키는 것으로 나타났으며, 이는 ALS 치료로서의 잠재력을 강조합니다.

NeuroSense Therapeutics a annoncé l'acceptation de deux résumés axés sur leur principal candidat thérapeutique, PrimeC, pour le traitement de la sclérose latérale amyotrophique (SLA), lors de la Réunion Annuelle du Consortium ALS du Nord-Est en 2024. Les résumés présenteront des données de l'étude PARADIGM de Phase 2b de NeuroSense.

Le Dr Merit Cudkowicz de l'hôpital général du Massachusetts présentera les résultats cliniques, tandis que le Dr Cristian Lunetta de NEMO à Milan discutera de l'analyse des biomarqueurs. Des résultats récents ont montré que PrimeC a réduit la progression de la maladie de 36% (p=0.009) et amélioré les taux de survie de 43% par rapport au placebo, soulignant son potentiel en tant que thérapie révolutionnaire pour la SLA.

NeuroSense Therapeutics hat die Annahme von zwei Abstracts angekündigt, die sich auf ihren Hauptkandidaten PrimeC zur Behandlung von amyotropher Lateralsklerose (ALS) konzentrieren, während der Jahrestagung des Nordost-ALS-Konsortiums 2024. Die Abstracts werden Daten aus der Phase 2b PARADIGM-Studie von NeuroSense präsentieren.

Dr. Merit Cudkowicz vom Massachusetts General Hospital wird klinische Ergebnisse präsentieren, während Dr. Cristian Lunetta von NEMO in Mailand die Biomarker-Analyse diskutieren wird. Jüngste Ergebnisse zeigten, dass PrimeC das Fortschreiten der Krankheit um 36% (p=0.009) reduzierte und die Überlebensraten im Vergleich zu Placebo um 43% verbesserte, was sein Potenzial als bahnbrechende ALS-Therapie hervorhebt.

Positive
  • PrimeC demonstrated a 36% reduction in disease progression (p=0.009)
  • PrimeC showed a 43% improvement in survival rates compared to placebo
  • Two abstracts on PrimeC accepted for presentation at a major ALS conference
Negative
  • None.

Insights

The acceptance of two abstracts on PrimeC for presentation at the 2024 NEALS Annual Meeting is a positive development for NeuroSense Therapeutics. The data from the Phase 2b PARADIGM study, showing a 36% reduction in disease progression (p=0.009) and a 43% improvement in survival rates compared to placebo, are significant findings in ALS research. These results suggest PrimeC could be a promising treatment for ALS, a devastating neurodegenerative disease with therapeutic options. The involvement of renowned experts like Dr. Merit Cudkowicz and Dr. Cristian Lunetta adds credibility to the research. However, it's important to note that while these results are encouraging, they are from a Phase 2b study and further research, including Phase 3 trials, will be necessary to confirm PrimeC's efficacy and safety profile before potential FDA approval.

CAMBRIDGE, Mass., Oct. 7, 2024 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced the acceptance of two abstracts focusing on the company's lead drug candidate, PrimeC, for the treatment of Amyotrophic Lateral Sclerosis (ALS). These abstracts will be presented at the 2024 Annual Northeastern Amyotrophic Lateral Sclerosis (NEALS) Consortium Meeting, taking place October 21 to October 24 in Clearwater, Florida.

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The abstracts will highlight groundbreaking data from NeuroSense's Phase 2b PARADIGM study. The first abstract, presenting clinical outcomes, will be delivered by renowned clinician Dr. Merit Cudkowicz, Chief of Neurology at Massachusetts General Hospital (MGH) and Director of the Sean M. Healey & AMG Center for ALS, USA. The second abstract, focused on biomarker analysis, will be presented by Dr. Cristian Lunetta, a leading neurologist and ALS specialist from the NEuroMuscular Omnicentre (NEMO) in Milan, Italy.

These presentations underscore NeuroSense's commitment to driving forward ALS research and the development of innovative treatments for this devastating disease. The company's recent findings demonstrated that PrimeC reduced disease progression by 36% reduction in disease progression (p=0.009) and a 43% improvement in survival rates compared to placebo, further solidifying PrimeC's potential as a breakthrough therapy for ALS.

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 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

About ALSFRS-R

Disease progression is measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), which is the most widely used ALS tracking tool accepted by the FDA, utilized by neurologists treating ALS patients, in clinical trials, and by other regulators to determine disease progression. It tracks 12 changes in a person's physical abilities over time including functions such as: speech, walking, climbing stairs, dressing/hygiene, handwriting, turning in bed, cutting food, salivation, swallowing, and breathing.  A single point change on the ALSFRS-R has a significant impact on ALS patients, such as the transition from independent feeding to requiring assistance or independent breathing to needing to use a machine ventilator.

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. 96% of the trial participants who completed the 6-month double-blind portion of the trial chose to receive treatment with PrimeC through a 12-month open label extension. Furthermore, to date (June 2024) all participants that completed the 18-month trial treatment duration, requested to continue PrimeC, which is provided to them in an Investigator Initiated Trial, not limited with time.

As previously reported, in the 6-month double-blind segment of the trial, the data showed clinically meaningful signs of efficacy with a 29% difference in favor of PrimeC vs placebo in analysis of the intent to treat (ITT) population. In the PP top-line analysis from PARADIGM, a statistically significant slowing of disease progression was observed with a 37.4% (p=0.03) difference in ALSFRS-R in favor of PrimeC vs placebo. 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 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 a Phase 2a clinical trial which met its safety and efficacy endpoints including reducing functional and respiratory deterioration and statistically significant changes in ALS-related biological markers indicating PrimeC's biological activity. 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.

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 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, 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 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 and 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.

Cision View original content:https://www.prnewswire.com/news-releases/neurosense-therapeutics-announces-acceptance-of-two-primec-abstracts-at-the-2024-neals-annual-meeting-302268746.html

SOURCE NeuroSense

FAQ

What were the key results of NeuroSense's Phase 2b PARADIGM study for PrimeC in ALS treatment?

The Phase 2b PARADIGM study showed that PrimeC reduced ALS disease progression by 36% (p=0.009) and improved survival rates by 43% compared to placebo.

Where will NeuroSense Therapeutics (NRSN) present their PrimeC abstracts in October 2024?

NeuroSense will present two PrimeC abstracts at the 2024 Annual Northeastern Amyotrophic Lateral Sclerosis (NEALS) Consortium Meeting in Clearwater, Florida, from October 21 to 24, 2024.

Who will present the clinical outcomes of PrimeC at the 2024 NEALS Annual Meeting?

Dr. Merit Cudkowicz, Chief of Neurology at Massachusetts General Hospital and Director of the Sean M. Healey & AMG Center for ALS, will present the clinical outcomes of PrimeC at the 2024 NEALS Annual Meeting.

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