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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：外國發行人報告
美股SEC公告 ·  2024/07/09 21:30

Moomoo AI 已提取核心訊息

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 宣佈其針對ALS患者的12個月PARADIGm階段20億研究PrimeC的額外積極結果。試驗顯示，在意向治療人群中，無併發症生存率提高了57%，而在按方案人群中，相較於安慰劑的顯著提高達到73%。研究還顯示，PrimeC使疾病進展減緩了36%，生存率提高了43%。該藥物在呼吸功能方面顯示出增強的療效，意向治療人群在6個月時的慢性肺活量改善率從13%提高到12個月的20%。對疾病進展的分析顯示，在ALSFRS-R評分中顯示輕微下降的患者中，PrimeC與安慰劑相比的比率爲4.5:1。這些結果在12個月的ALS安慰劑對照研究中被認爲是前所未有的。該公司計劃將這些結果提交給監管機構，包括FDA，以討論後續的路徑。PrimeC結合了環丙沙星和塞來昔布，並採用了一種新穎的緩釋配方，已經獲得FDA和歐洲藥品管理局的孤兒藥資格。
NeuroSense Therapeutics 宣佈其針對ALS患者的12個月PARADIGm階段20億研究PrimeC的額外積極結果。試驗顯示，在意向治療人群中，無併發症生存率提高了57%，而在按方案人群中，相較於安慰劑的顯著提高達到73%。研究還顯示，PrimeC使疾病進展減緩了36%，生存率提高了43%。該藥物在呼吸功能方面顯示出增強的療效，意向治療人群在6個月時的慢性肺活量改善率從13%提高到12個月的20%。對疾病進展的分析顯示，在ALSFRS-R評分中顯示輕微下降的患者中，PrimeC與安慰劑相比的比率爲4.5:1。這些結果在12個月的ALS安慰劑對照研究中被認爲是前所未有的。該公司計劃將這些結果提交給監管機構，包括FDA，以討論後續的路徑。PrimeC結合了環丙沙星和塞來昔布，並採用了一種新穎的緩釋配方，已經獲得FDA和歐洲藥品管理局的孤兒藥資格。
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