[6-K] NeuroSense Therapeutics Ltd. Current Report (Foreign Issuer)
NeuroSense reported a statistically significant clinical benefit for PrimeC at 18 months. An NfL-adjusted MMRM analysis showed a p=0.03 result, corresponding to a 28% relative difference in decline on the ALS Functional Rating Scale-Revised (ALSFRS-R) favoring patients who received PrimeC from study start versus those who began with placebo and switched to PrimeC after six months. The company states these data underscore the clinical importance of initiating PrimeC early in disease progression.
NeuroSense ha riportato un beneficio clinico statisticamente significativo per PrimeC a 18 mesi. Un'analisi MMRM aggiustata per NfL ha mostrato un valore p di 0,03, corrispondente a una differenza relativa del 28% nel declino della scala ALS Functional Rating Scale-Revised (ALSFRS-R) a favore dei pazienti che hanno iniziato PrimeC dall'inizio dello studio rispetto a quelli che hanno iniziato con placebo e hanno passato a PrimeC dopo sei mesi. L'azienda afferma che questi dati sottolineano l'importanza clinica di iniziare PrimeC precocemente nel decorso della malattia.
NeuroSense informó un beneficio clínico estadísticamente significativo de PrimeC a los 18 meses. Un análisis MMRM ajustado por NfL mostró un resultado p=0,03, correspondiente a una diferencia relativa del 28% en el deterioro en la Escala de Valoración Funcional de la Esclerosis Lateral Amiotrófica-Revisada (ALSFRS-R) a favor de los pacientes que recibieron PrimeC desde el inicio del estudio frente a aquellos que comenzaron con placebo y cambiaron a PrimeC después de seis meses. La empresa afirma que estos datos subrayan la importancia clínica de iniciar PrimeC temprano en la progresión de la enfermedad.
NeuroSense는 18개월 시점에서 PrimeC에 대해 통계적으로 유의미한 임상 이익을 보고했습니다. NfL 보정 MMRM 분석에서 p=0.03의 결과가 나타났으며, 이는 ALS 기능 평가 척도-수정판(ALSFRS-R)의 저하에서 초기부터 PrimeC를 받은 환자군이 무작위 배정으로 시작한 후 6개월에 교차로 PrimeC로 전환한 대조군에 비해 상대적으로 28% 더 감소했다는 것을 의미합니다. 회사는 이러한 데이터가 질병 진행 초기 PrimeC를 시작하는 것의 임상적 중요성을 강조한다고 말합니다.
NeuroSense a rapporté un bénéfice clinique statistiquement significatif de PrimeC à 18 mois. Une analyse MMRM ajustée pour NfL a montré un résultat p=0,03, correspondant à une différence relative de 28% dans le déclin de l'échelle ALS Functional Rating Scale-Revised (ALSFRS-R) en faveur des patients ayant reçu PrimeC dès le début de l'étude par rapport à ceux ayant commencé par placebo et basculé vers PrimeC après six mois. La société indique que ces données soulignent l'importance clinique d'initier PrimeC tôt dans la progression de la maladie.
NeuroSense berichtete einen statistisch signifikanten klinischen Nutzen von PrimeC nach 18 Monaten. Eine NfL-adjustierte MMRM-Analyse zeigte ein p=0,03-Ergebnis, was einer relativen Abweichung von 28% im Abbau der ALS Functional Rating Scale-Revised (ALSFRS-R) zugunsten der Patienten entspricht, die PrimeC von Studienbeginn an erhielten, gegenüber denen, die mit Placebo begannen und nach sechs Monaten auf PrimeC wechselten. Das Unternehmen erklärt, dass diese Daten die klinische Bedeutung der frühzeitigen Einleitung von PrimeC im Krankheitsverlauf unterstreichen.
أفادت NeuroSense بفائدة سريرية ذات دلالة إحصائية لـ PrimeC عند 18 شهرًا. أظهر تحليل MMRM مُعدل لـ NfL نتيجة p=0.03، وهو ما يمثل فرقًا نسبته 28% في التراجع بمقياس ALS Functional Rating Scale-Revised (ALSFRS-R) لصالح المرضى الذين تلقوا PrimeC من بدء الدراسة مقارنة بالذين بدؤوا بالدواء الوهمي وتحولوا إلى PrimeC بعد ستة أشهر. تقول الشركة أن هذه البيانات تؤكد الأهمية السريرية لبدء PrimeC مبكرًا في تقدم المرض.
NeuroSense 报告显示 PrimeC 在18个月时具有统计学意义的临床获益。 一项针对 NfL 调整的 MMRM 分析显示 p=0.03 的结果，相当于在 ALS 功能评定量表修订版 (ALSFRS-R) 的下降上，采用 PrimeC 的起始患者相对于在研究开始时接受安慰剂并在六个月后改为 PrimeC 的患者，呈现 28% 的相对差异。公司表示，这些数据强调在疾病进展早期启动 PrimeC 的临床重要性。
- Statistically significant result at 18 months with p=0.03 reported
- 28% relative difference in ALSFRS-R decline favoring immediate PrimeC treatment
- Comparison includes delayed-treatment control (placebo then PrimeC after six months), supporting benefit of earlier initiation
- None.
Insights
TL;DR: NfL-adjusted MMRM shows a statistically significant 28% slower ALSFRS-R decline at 18 months (p=0.03) with early PrimeC.
The reported NfL-adjusted mixed-model repeated measures analysis yields a p-value of 0.03 at 18 months, indicating statistical significance by conventional thresholds. The magnitude — a 28% relative difference in ALSFRS-R decline — is a clinically meaningful measure for a progressive neurodegenerative disease like ALS, and the comparison explicitly contrasts immediate treatment versus delayed (placebo for six months) initiation. The brief text does not provide absolute score changes, confidence intervals, sample size, safety data, or subgroup details, so assessment of robustness, generalizability, and clinical relevance beyond the stated relative difference is limited by missing details.
TL;DR: Positive efficacy signal at 18 months may materially affect NeuroSense's development value if confirmed with full data.
The filing highlights a statistically significant efficacy signal (p=0.03) and quantifies a 28% relative benefit on ALSFRS-R for early treatment with PrimeC versus delayed treatment. This is presented as evidence supporting early initiation. The disclosure lacks enrollment numbers, statistical power, regulatory context, and safety or durability data, preventing a complete evaluation of commercial or regulatory impact from this excerpt alone.
NeuroSense ha riportato un beneficio clinico statisticamente significativo per PrimeC a 18 mesi. Un'analisi MMRM aggiustata per NfL ha mostrato un valore p di 0,03, corrispondente a una differenza relativa del 28% nel declino della scala ALS Functional Rating Scale-Revised (ALSFRS-R) a favore dei pazienti che hanno iniziato PrimeC dall'inizio dello studio rispetto a quelli che hanno iniziato con placebo e hanno passato a PrimeC dopo sei mesi. L'azienda afferma che questi dati sottolineano l'importanza clinica di iniziare PrimeC precocemente nel decorso della malattia.
NeuroSense informó un beneficio clínico estadísticamente significativo de PrimeC a los 18 meses. Un análisis MMRM ajustado por NfL mostró un resultado p=0,03, correspondiente a una diferencia relativa del 28% en el deterioro en la Escala de Valoración Funcional de la Esclerosis Lateral Amiotrófica-Revisada (ALSFRS-R) a favor de los pacientes que recibieron PrimeC desde el inicio del estudio frente a aquellos que comenzaron con placebo y cambiaron a PrimeC después de seis meses. La empresa afirma que estos datos subrayan la importancia clínica de iniciar PrimeC temprano en la progresión de la enfermedad.
NeuroSense는 18개월 시점에서 PrimeC에 대해 통계적으로 유의미한 임상 이익을 보고했습니다. NfL 보정 MMRM 분석에서 p=0.03의 결과가 나타났으며, 이는 ALS 기능 평가 척도-수정판(ALSFRS-R)의 저하에서 초기부터 PrimeC를 받은 환자군이 무작위 배정으로 시작한 후 6개월에 교차로 PrimeC로 전환한 대조군에 비해 상대적으로 28% 더 감소했다는 것을 의미합니다. 회사는 이러한 데이터가 질병 진행 초기 PrimeC를 시작하는 것의 임상적 중요성을 강조한다고 말합니다.
NeuroSense a rapporté un bénéfice clinique statistiquement significatif de PrimeC à 18 mois. Une analyse MMRM ajustée pour NfL a montré un résultat p=0,03, correspondant à une différence relative de 28% dans le déclin de l'échelle ALS Functional Rating Scale-Revised (ALSFRS-R) en faveur des patients ayant reçu PrimeC dès le début de l'étude par rapport à ceux ayant commencé par placebo et basculé vers PrimeC après six mois. La société indique que ces données soulignent l'importance clinique d'initier PrimeC tôt dans la progression de la maladie.
NeuroSense berichtete einen statistisch signifikanten klinischen Nutzen von PrimeC nach 18 Monaten. Eine NfL-adjustierte MMRM-Analyse zeigte ein p=0,03-Ergebnis, was einer relativen Abweichung von 28% im Abbau der ALS Functional Rating Scale-Revised (ALSFRS-R) zugunsten der Patienten entspricht, die PrimeC von Studienbeginn an erhielten, gegenüber denen, die mit Placebo begannen und nach sechs Monaten auf PrimeC wechselten. Das Unternehmen erklärt, dass diese Daten die klinische Bedeutung der frühzeitigen Einleitung von PrimeC im Krankheitsverlauf unterstreichen.
FAQ
What efficacy result did NeuroSense (NRSN) report for PrimeC?
How large was the treatment effect on ALSFRS-R reported by NeuroSense?
Did the filing describe the trial comparator or design detail?
Does the document provide safety or sample size information?
What conclusion does NeuroSense draw from these data?
