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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 ·  08/01 09:26

Moomoo AI 已提取核心信息

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.
2024年8月1日，生物技术公司NeuroSense Therapeutics Ltd.公布了其治疗肌萎缩侧索硬化症（ALS）的产品PrimeC II期临床试验的积极结果。PARADIGm研究的12个月数据显示，PrimeC能在患者中调节铁水平，这与改善生存率和疾病缓解有关。这些发现补充了先前的结果，PrimeC能使病情进展减缓36％，使生存率提高43％。这项试验涵盖了来自加拿大，意大利和以色列的68名参与者，显示出铁蛋白水平显著降低，转铁蛋白水平显著升高，表明可能减轻了ALS病理过程。多数试验参与者选择在初始6个月的盲态试验后继续接受PrimeC治疗。该公司正在准备与FDA进一步讨论临床和监管途径，并正在与潜在合作伙伴就PrimeC获得批准后的市场营销展开高级别讨论。ALS是一种致命的神经退行性疾病，治疗选择有限，PrimeC已获得美国和欧盟的孤儿药物认定。
2024年8月1日，生物技术公司NeuroSense Therapeutics Ltd.公布了其治疗肌萎缩侧索硬化症（ALS）的产品PrimeC II期临床试验的积极结果。PARADIGm研究的12个月数据显示，PrimeC能在患者中调节铁水平，这与改善生存率和疾病缓解有关。这些发现补充了先前的结果，PrimeC能使病情进展减缓36％，使生存率提高43％。这项试验涵盖了来自加拿大，意大利和以色列的68名参与者，显示出铁蛋白水平显著降低，转铁蛋白水平显著升高，表明可能减轻了ALS病理过程。多数试验参与者选择在初始6个月的盲态试验后继续接受PrimeC治疗。该公司正在准备与FDA进一步讨论临床和监管途径，并正在与潜在合作伙伴就PrimeC获得批准后的市场营销展开高级别讨论。ALS是一种致命的神经退行性疾病，治疗选择有限，PrimeC已获得美国和欧盟的孤儿药物认定。
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