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6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

6-K：外国发行人报告
美股SEC公告 ·  2024/10/09 06:16

Moomoo AI 已提取核心信息

NeuroSense Therapeutics has initiated the regulatory process for early commercialization approval of PrimeC under Health Canada's NOC/c policy, following successful Phase 2b trial results. The ALS treatment demonstrated a 36% reduction in disease progression (p=0.009) and a 43% improvement in survival rates compared to placebo.The PARADIGM Phase 2b trial, conducted across Canada, Italy, and Israel with 68 participants, showed significant efficacy with a 29% improvement in the intent-to-treat population. In the per-protocol analysis, PrimeC achieved a statistically significant 37.4% (p=0.03) difference in ALSFRS-R compared to placebo, demonstrating effectiveness beyond the standard Riluzole treatment.PrimeC, a novel extended-release oral formulation combining ciprofloxacin and celecoxib, has received Orphan Drug Designation from both FDA and EMA. The company plans to expand its regulatory approval efforts beyond Canada, aiming to address the growing ALS patient population, expected to increase by 24% by 2040 in the U.S. and EU.
NeuroSense Therapeutics has initiated the regulatory process for early commercialization approval of PrimeC under Health Canada's NOC/c policy, following successful Phase 2b trial results. The ALS treatment demonstrated a 36% reduction in disease progression (p=0.009) and a 43% improvement in survival rates compared to placebo.The PARADIGM Phase 2b trial, conducted across Canada, Italy, and Israel with 68 participants, showed significant efficacy with a 29% improvement in the intent-to-treat population. In the per-protocol analysis, PrimeC achieved a statistically significant 37.4% (p=0.03) difference in ALSFRS-R compared to placebo, demonstrating effectiveness beyond the standard Riluzole treatment.PrimeC, a novel extended-release oral formulation combining ciprofloxacin and celecoxib, has received Orphan Drug Designation from both FDA and EMA. The company plans to expand its regulatory approval efforts beyond Canada, aiming to address the growing ALS patient population, expected to increase by 24% by 2040 in the U.S. and EU.
NeuroSense Therapeutics已启动监管过程，以根据加拿大卫生部的NOC/c政策申请PrimeC的早期商业化批准，此举是基于成功的第20亿期试验结果。该ALS治疗显示出比安慰剂有36%的疾病进展减少（p=0.009）和43%的生存率改善。PARADIGm第20亿期试验在加拿大、意大利和以色列共68名参与者中进行，显示出显著的疗效，意向治疗人群改善了29%。在依照方案分析中，PrimeC在ALSFRS-R中与安慰剂相比实现了统计学显著的37.4%（p=0.03）的差异，证明其效能超越了标准的Riluzole治疗。PrimeC是一种新型的缓释口服制剂，结合了环丙沙星和塞来昔布，已获得FDA和EMA的孤儿药资格。该公司计划将其监管审批工作扩展至加拿大以外，旨在应对不断增长的ALS患者群体，预计到2040年，美国和欧盟的该患者群体将增加24%。
NeuroSense Therapeutics已启动监管过程，以根据加拿大卫生部的NOC/c政策申请PrimeC的早期商业化批准，此举是基于成功的第20亿期试验结果。该ALS治疗显示出比安慰剂有36%的疾病进展减少（p=0.009）和43%的生存率改善。PARADIGm第20亿期试验在加拿大、意大利和以色列共68名参与者中进行，显示出显著的疗效，意向治疗人群改善了29%。在依照方案分析中，PrimeC在ALSFRS-R中与安慰剂相比实现了统计学显著的37.4%（p=0.03）的差异，证明其效能超越了标准的Riluzole治疗。PrimeC是一种新型的缓释口服制剂，结合了环丙沙星和塞来昔布，已获得FDA和EMA的孤儿药资格。该公司计划将其监管审批工作扩展至加拿大以外，旨在应对不断增长的ALS患者群体，预计到2040年，美国和欧盟的该患者群体将增加24%。
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