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NeuroSense Therapeutics | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

NeuroSense Therapeutics | 6-K:外国发行人报告

SEC announcement ·  01/09 00:00
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NeuroSense Therapeutics Ltd., a clinical-stage biotechnology company, has reported significant progress in its clinical trials and development plans for PrimeC, its lead drug candidate for treating amyotrophic lateral sclerosis (ALS). On January 9, 2024, the company issued a press release summarizing its achievements in 2023, including positive results from the Phase 2b PARADIGM trial, which showed a statistically significant slowing of ALS disease progression. The trial demonstrated a 37.4% difference in the ALS functional rating scale revised (ALSFRS-R) compared to placebo, indicating a potential new approach to treating ALS and other neurodegenerative diseases. The company also highlighted its upcoming catalysts for 2024, such as the expected End of Phase 2 meetings with the FDA and EMA in Q2 2024, and the reporting of biomarker study results as...Show More
NeuroSense Therapeutics Ltd., a clinical-stage biotechnology company, has reported significant progress in its clinical trials and development plans for PrimeC, its lead drug candidate for treating amyotrophic lateral sclerosis (ALS). On January 9, 2024, the company issued a press release summarizing its achievements in 2023, including positive results from the Phase 2b PARADIGM trial, which showed a statistically significant slowing of ALS disease progression. The trial demonstrated a 37.4% difference in the ALS functional rating scale revised (ALSFRS-R) compared to placebo, indicating a potential new approach to treating ALS and other neurodegenerative diseases. The company also highlighted its upcoming catalysts for 2024, such as the expected End of Phase 2 meetings with the FDA and EMA in Q2 2024, and the reporting of biomarker study results as early as Q1 2024. NeuroSense is advancing discussions for strategic partnerships and has confirmed its chemistry, manufacturing, and controls (CMC) development plans with the FDA in anticipation of a Phase 3 pivotal trial. Additionally, the company has begun a Phase 2 study for Alzheimer's Disease and continues to explore business opportunities with biotech VCs and pharmaceutical companies.
临床阶段的生物技术公司NeuroSense Therapeutics Ltd.报告称,其治疗肌萎缩性侧索硬化(ALS)的主要候选药物PrimeC的临床试验和开发计划取得了重大进展。2024年1月9日,该公司发布了一份新闻稿,总结了其在2023年取得的成就,包括2b期PARADIGM试验的积极结果,该试验显示肌萎缩性侧索硬化症的进展在统计学上显著放缓。该试验表明,与安慰剂相比,经修订的肌萎缩性侧索硬化症功能评级量表(ALSFRS-R)存在37.4%的差异,这表明一种治疗肌萎缩性侧索硬化症和其他神经退行性疾病的潜在新方法。该公司还强调了其即将到来的2024年催化剂,例如预计于2024年第二季度与美...展开全部
临床阶段的生物技术公司NeuroSense Therapeutics Ltd.报告称,其治疗肌萎缩性侧索硬化(ALS)的主要候选药物PrimeC的临床试验和开发计划取得了重大进展。2024年1月9日,该公司发布了一份新闻稿,总结了其在2023年取得的成就,包括2b期PARADIGM试验的积极结果,该试验显示肌萎缩性侧索硬化症的进展在统计学上显著放缓。该试验表明,与安慰剂相比,经修订的肌萎缩性侧索硬化症功能评级量表(ALSFRS-R)存在37.4%的差异,这表明一种治疗肌萎缩性侧索硬化症和其他神经退行性疾病的潜在新方法。该公司还强调了其即将到来的2024年催化剂,例如预计于2024年第二季度与美国食品药品管理局和欧洲药品管理局举行的第二阶段会议结束,以及最早在2024年第一季度报告的生物标志物研究结果。NeuroSense正在推进战略合作伙伴关系的讨论,并已与美国食品药品管理局确认了其化学、制造和控制(CMC)开发计划,预计将进行3期关键试验。此外,该公司已开始对阿尔茨海默氏病进行二期研究,并继续与生物技术风险投资公司和制药公司探索商机。
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