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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 ·  2024/10/09 21:16

Moomoo AI 已提取核心訊息

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已啓動監管過程，以根據加拿大衛生部的NOC/c政策申請PrimeC的早期商業化批准，此舉是基於成功的第20億期試驗結果。該ALS治療顯示出比安慰劑有36%的疾病進展減少（p=0.009）和43%的生存率改善。PARADIGm第20億期試驗在加拿大、意大利和以色列共68名參與者中進行，顯示出顯著的療效，意向治療人群改善了29%。在依照方案分析中，PrimeC在ALSFRS-R中與安慰劑相比實現了統計學顯著的37.4%（p=0.03）的差異，證明其效能超越了標準的Riluzole治療。PrimeC是一種新型的緩釋口服制劑，結合了環丙沙星和塞來昔布，已獲得FDA和EMA的孤兒藥資格。該公司計劃將其監管審批工作擴展至加拿大以外，旨在應對不斷增長的ALS患者群體，預計到2040年，美國和歐盟的該患者群體將增加24%。
NeuroSense Therapeutics已啓動監管過程，以根據加拿大衛生部的NOC/c政策申請PrimeC的早期商業化批准，此舉是基於成功的第20億期試驗結果。該ALS治療顯示出比安慰劑有36%的疾病進展減少（p=0.009）和43%的生存率改善。PARADIGm第20億期試驗在加拿大、意大利和以色列共68名參與者中進行，顯示出顯著的療效，意向治療人群改善了29%。在依照方案分析中，PrimeC在ALSFRS-R中與安慰劑相比實現了統計學顯著的37.4%（p=0.03）的差異，證明其效能超越了標準的Riluzole治療。PrimeC是一種新型的緩釋口服制劑，結合了環丙沙星和塞來昔布，已獲得FDA和EMA的孤兒藥資格。該公司計劃將其監管審批工作擴展至加拿大以外，旨在應對不斷增長的ALS患者群體，預計到2040年，美國和歐盟的該患者群體將增加24%。
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