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6-K：外國發行人報告
美股sec公告 ·  05/07 22:24
牛牛AI助理已提取核心訊息
NeuroSense Therapeutics Ltd., a biotechnology company focused on neurodegenerative diseases, announced on May 7, 2024, positive results from its Phase 2b PARADIGM clinical trial. The trial evaluated the efficacy of PrimeC, the company's lead drug candidate, in slowing the progression of amyotrophic lateral sclerosis (ALS) in high-risk patients. The data revealed a statistically significant 43% slowing of disease progression in patients treated with PrimeC compared to placebo. The results, based on the ALS Functional Rating Scale-Revised (ALSFRS-R), showed a 5.04 points difference in favor of PrimeC. The trial included 68 participants across Canada, Italy, and Israel, with 96% opting to continue PrimeC treatment in a 12-month open label extension. NeuroSense plans to use these findings to inform the design of an upcoming pivotal trial. The company's CEO, Alon Ben-Noon, expressed optimism about PrimeC's potential impact on ALS treatment standards. PrimeC has been granted Orphan Drug Designation by the FDA and the European Medicines Agency.
NeuroSense Therapeutics Ltd., a biotechnology company focused on neurodegenerative diseases, announced on May 7, 2024, positive results from its Phase 2b PARADIGM clinical trial. The trial evaluated the efficacy of PrimeC, the company's lead drug candidate, in slowing the progression of amyotrophic lateral sclerosis (ALS) in high-risk patients. The data revealed a statistically significant 43% slowing of disease progression in patients treated with PrimeC compared to placebo. The results, based on the ALS Functional Rating Scale-Revised (ALSFRS-R), showed a 5.04 points difference in favor of PrimeC. The trial included 68 participants across Canada, Italy, and Israel, with 96% opting to continue PrimeC treatment in a 12-month open label extension. NeuroSense plans to use these findings to inform the design of an upcoming pivotal trial. The company's CEO, Alon Ben-Noon, expressed optimism about PrimeC's potential impact on ALS treatment standards. PrimeC has been granted Orphan Drug Designation by the FDA and the European Medicines Agency.
專注於神經退行性疾病的生物技術公司NeuroSense Therapeutics Ltd. 於2024年5月7日宣佈其2b期PARADIGM臨床試驗的積極結果。該試驗評估了該公司主要候選藥物PrimeC在減緩高風險患者肌萎縮性側索硬化（ALS）進展方面的功效。數據顯示，與安慰劑相比，接受PrimeC治療的患者的疾病進展減緩了43％，具有統計學意義。根據ALS功能評級表修訂版（ALSFRS-R）得出的結果顯示，PrimeC相差5.04個百分點。該試驗包括來自加拿大、意大利和以色列的68名參與者，其中96％的人選擇在12個月的開放標籤延期內繼續進行PrimeC治療。NeuroSense計劃利用這些發現爲即將到來的關鍵試驗的設計提供信息。該公司首席執行官阿隆·本·努恩對PrimeC對肌萎縮性側索硬化症治療標準的潛在影響表示樂觀。PrimeC已被美國食品藥品管理局和歐洲藥品管理局授予孤兒藥稱號。
專注於神經退行性疾病的生物技術公司NeuroSense Therapeutics Ltd. 於2024年5月7日宣佈其2b期PARADIGM臨床試驗的積極結果。該試驗評估了該公司主要候選藥物PrimeC在減緩高風險患者肌萎縮性側索硬化（ALS）進展方面的功效。數據顯示，與安慰劑相比，接受PrimeC治療的患者的疾病進展減緩了43％，具有統計學意義。根據ALS功能評級表修訂版（ALSFRS-R）得出的結果顯示，PrimeC相差5.04個百分點。該試驗包括來自加拿大、意大利和以色列的68名參與者，其中96％的人選擇在12個月的開放標籤延期內繼續進行PrimeC治療。NeuroSense計劃利用這些發現爲即將到來的關鍵試驗的設計提供信息。該公司首席執行官阿隆·本·努恩對PrimeC對肌萎縮性側索硬化症治療標準的潛在影響表示樂觀。PrimeC已被美國食品藥品管理局和歐洲藥品管理局授予孤兒藥稱號。
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