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6-K：外國發行人報告
美股SEC公告 ·  08/01 09:26

Moomoo AI 已提取核心訊息

NeuroSense Therapeutics Ltd., a biotechnology company, announced positive results from its Phase 2b clinical trial for PrimeC, a treatment for Amyotrophic Lateral Sclerosis (ALS), on August 1, 2024. The 12-month data from the PARADIGM study showed that PrimeC regulated iron levels in patients, which is associated with improved survival and disease mitigation. These findings add to previous results where PrimeC slowed disease progression by 36% and improved survival rates by 43%. The trial, which included 68 participants across Canada, Italy, and Israel, demonstrated significant decreases in ferritin levels and increases in transferrin levels, indicating potential alleviation of ALS pathology. The majority of trial participants chose to continue with PrimeC treatment after the initial 6-month double-blind phase. The company is preparing to discuss further clinical and regulatory pathways with the FDA and is in advanced discussions with potential partners for the marketing of PrimeC post-approval. ALS is a fatal neurodegenerative disease with limited treatment options, and PrimeC has been granted Orphan Drug Designation in the U.S. and EU.
NeuroSense Therapeutics Ltd., a biotechnology company, announced positive results from its Phase 2b clinical trial for PrimeC, a treatment for Amyotrophic Lateral Sclerosis (ALS), on August 1, 2024. The 12-month data from the PARADIGM study showed that PrimeC regulated iron levels in patients, which is associated with improved survival and disease mitigation. These findings add to previous results where PrimeC slowed disease progression by 36% and improved survival rates by 43%. The trial, which included 68 participants across Canada, Italy, and Israel, demonstrated significant decreases in ferritin levels and increases in transferrin levels, indicating potential alleviation of ALS pathology. The majority of trial participants chose to continue with PrimeC treatment after the initial 6-month double-blind phase. The company is preparing to discuss further clinical and regulatory pathways with the FDA and is in advanced discussions with potential partners for the marketing of PrimeC post-approval. ALS is a fatal neurodegenerative disease with limited treatment options, and PrimeC has been granted Orphan Drug Designation in the U.S. and EU.
生物技術公司NeuroSense Therapeutics Ltd.於2024年8月1日宣佈其Amyotrophic Lateral Sclerosis（ALS）治療藥物PrimeC在其第二十期臨床試驗中獲得積極結果。PARADIGm研究的12個月數據顯示，PrimeC調節患者的鐵水平，這與改善生存率和疾病緩解有關。這些發現補充了之前的結果，即PrimeC將疾病進展減緩36％並將生存率提高了43％。此次試驗在加拿大、意大利和以色列共68名參與者中進行，表明在鐵蛋白水平顯著降低和轉鐵蛋白水平顯著升高方面，可能減輕ALS病理學。大多數試驗參與者選擇在最初的6個月盲目期後繼續使用PrimeC治療。該公司正在準備與FDA討論進一步的臨床和監管途徑，並正在與潛在合作伙伴進行PrimeC上市後的市場營銷的高級討論。ALS是一種致命的神經退行性疾病，治療選擇有限，PrimeC已在美國和歐盟獲得孤兒藥物認證。
生物技術公司NeuroSense Therapeutics Ltd.於2024年8月1日宣佈其Amyotrophic Lateral Sclerosis（ALS）治療藥物PrimeC在其第二十期臨床試驗中獲得積極結果。PARADIGm研究的12個月數據顯示，PrimeC調節患者的鐵水平，這與改善生存率和疾病緩解有關。這些發現補充了之前的結果，即PrimeC將疾病進展減緩36％並將生存率提高了43％。此次試驗在加拿大、意大利和以色列共68名參與者中進行，表明在鐵蛋白水平顯著降低和轉鐵蛋白水平顯著升高方面，可能減輕ALS病理學。大多數試驗參與者選擇在最初的6個月盲目期後繼續使用PrimeC治療。該公司正在準備與FDA討論進一步的臨床和監管途徑，並正在與潛在合作伙伴進行PrimeC上市後的市場營銷的高級討論。ALS是一種致命的神經退行性疾病，治療選擇有限，PrimeC已在美國和歐盟獲得孤兒藥物認證。
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