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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 ·  2024/07/09 21:30

Moomoo AI 已提取核心信息

NeuroSense Therapeutics announced additional positive results from its 12-month PARADIGM Phase 2b study of PrimeC in ALS patients. The trial demonstrated a 57% improvement in complication-free survival in the Intent to Treat population and a significant 73% improvement in the Per Protocol Population compared to placebo. The study also showed PrimeC slowed disease progression by 36% and improved survival rates by 43%.The drug showed enhanced efficacy in respiratory function, with Slow Vital Capacity improvement increasing from 13% at 6 months to 20% at 12 months in the ITT population. Analysis of disease progression revealed a favorable 4.5:1 ratio for PrimeC over placebo in patients showing minimal decline in ALSFRS-R scores. These results are considered unprecedented in a 12-month ALS placebo-controlled study.The company plans to submit these results to regulatory agencies, including the FDA, to discuss the path forward. PrimeC, which combines ciprofloxacin and celecoxib in a novel extended-release formulation, has already received Orphan Drug Designation from both the FDA and European Medicines Agency.
NeuroSense Therapeutics announced additional positive results from its 12-month PARADIGM Phase 2b study of PrimeC in ALS patients. The trial demonstrated a 57% improvement in complication-free survival in the Intent to Treat population and a significant 73% improvement in the Per Protocol Population compared to placebo. The study also showed PrimeC slowed disease progression by 36% and improved survival rates by 43%.The drug showed enhanced efficacy in respiratory function, with Slow Vital Capacity improvement increasing from 13% at 6 months to 20% at 12 months in the ITT population. Analysis of disease progression revealed a favorable 4.5:1 ratio for PrimeC over placebo in patients showing minimal decline in ALSFRS-R scores. These results are considered unprecedented in a 12-month ALS placebo-controlled study.The company plans to submit these results to regulatory agencies, including the FDA, to discuss the path forward. PrimeC, which combines ciprofloxacin and celecoxib in a novel extended-release formulation, has already received Orphan Drug Designation from both the FDA and European Medicines Agency.
NeuroSense Therapeutics 宣布其针对ALS患者的12个月PARADIGm阶段20亿研究PrimeC的额外积极结果。试验显示，在意向治疗人群中，无并发症生存率提高了57%，而在按方案人群中，相较于安慰剂的显著提高达到73%。研究还显示，PrimeC使疾病进展减缓了36%，生存率提高了43%。该药物在呼吸功能方面显示出增强的疗效，意向治疗人群在6个月时的慢性肺活量改善率从13%提高到12个月的20%。对疾病进展的分析显示，在ALSFRS-R评分中显示轻微下降的患者中，PrimeC与安慰剂相比的比率为4.5:1。这些结果在12个月的ALS安慰剂对照研究中被认为是前所未有的。该公司计划将这些结果提交给监管机构，包括FDA，以讨论后续的路径。PrimeC结合了环丙沙星和塞来昔布，并采用了一种新颖的缓释配方，已经获得FDA和欧洲药品管理局的孤儿药资格。
NeuroSense Therapeutics 宣布其针对ALS患者的12个月PARADIGm阶段20亿研究PrimeC的额外积极结果。试验显示，在意向治疗人群中，无并发症生存率提高了57%，而在按方案人群中，相较于安慰剂的显著提高达到73%。研究还显示，PrimeC使疾病进展减缓了36%，生存率提高了43%。该药物在呼吸功能方面显示出增强的疗效，意向治疗人群在6个月时的慢性肺活量改善率从13%提高到12个月的20%。对疾病进展的分析显示，在ALSFRS-R评分中显示轻微下降的患者中，PrimeC与安慰剂相比的比率为4.5:1。这些结果在12个月的ALS安慰剂对照研究中被认为是前所未有的。该公司计划将这些结果提交给监管机构，包括FDA，以讨论后续的路径。PrimeC结合了环丙沙星和塞来昔布，并采用了一种新颖的缓释配方，已经获得FDA和欧洲药品管理局的孤儿药资格。
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