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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 ·  05/07 10:24
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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.
专注于神经退行性疾病的生物技术公司NeuroSense Therapeutics Ltd. 于2024年5月7日宣布其2b期PARADIGM临床试验的积极结果。该试验评估了该公司主要候选药物PrimeC在减缓高风险患者肌萎缩性侧索硬化（ALS）进展方面的功效。数据显示，与安慰剂相比，接受PrimeC治疗的患者的疾病进展减缓了43％，具有统计学意义。根据ALS功能评级表修订版（ALSFRS-R）得出的结果显示，PrimeC相差5.04个百分点。该试验包括来自加拿大、意大利和以色列的68名参与者，其中96％的人选择在12个月的开放标签延期内继续进行PrimeC治疗。NeuroSense计划利用这些发现为即将到来的关键试验的设计提供信息。该公司首席执行官阿隆·本·努恩对PrimeC对肌萎缩性侧索硬化症治疗标准的潜在影响表示乐观。PrimeC已被美国食品药品管理局和欧洲药品管理局授予孤儿药称号。
专注于神经退行性疾病的生物技术公司NeuroSense Therapeutics Ltd. 于2024年5月7日宣布其2b期PARADIGM临床试验的积极结果。该试验评估了该公司主要候选药物PrimeC在减缓高风险患者肌萎缩性侧索硬化（ALS）进展方面的功效。数据显示，与安慰剂相比，接受PrimeC治疗的患者的疾病进展减缓了43％，具有统计学意义。根据ALS功能评级表修订版（ALSFRS-R）得出的结果显示，PrimeC相差5.04个百分点。该试验包括来自加拿大、意大利和以色列的68名参与者，其中96％的人选择在12个月的开放标签延期内继续进行PrimeC治疗。NeuroSense计划利用这些发现为即将到来的关键试验的设计提供信息。该公司首席执行官阿隆·本·努恩对PrimeC对肌萎缩性侧索硬化症治疗标准的潜在影响表示乐观。PrimeC已被美国食品药品管理局和欧洲药品管理局授予孤儿药称号。
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