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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 ·  07/17 08:01
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Alterity Therapeutics Limited, a biotechnology company, has reported positive interim data from its ATH434-202 Phase 2 clinical trial for treating Multiple System Atrophy (MSA). The trial, which is still ongoing, has shown encouraging results with 43% of participants demonstrating improvement in daily living activities and 29% showing stable or improved neurological symptoms after six months of treatment with ATH434. The drug was also well-tolerated with no serious adverse events related to the study drug reported. Additionally, clinical responders exhibited biomarker evidence of stable disease, including reduced accumulation of iron in the brain and stable levels of Neurofilament Light Chain, a marker of axonal injury. The trial's primary objective is to evaluate the impact of 12 months of treatment with ATH434 on brain volume in advanced MSA patients. Final data from the trial are expected in the first half of 2025. ATH434 has previously been granted Orphan drug designation for the treatment of MSA by the U.S. FDA and the European Commission.
Alterity Therapeutics Limited, a biotechnology company, has reported positive interim data from its ATH434-202 Phase 2 clinical trial for treating Multiple System Atrophy (MSA). The trial, which is still ongoing, has shown encouraging results with 43% of participants demonstrating improvement in daily living activities and 29% showing stable or improved neurological symptoms after six months of treatment with ATH434. The drug was also well-tolerated with no serious adverse events related to the study drug reported. Additionally, clinical responders exhibited biomarker evidence of stable disease, including reduced accumulation of iron in the brain and stable levels of Neurofilament Light Chain, a marker of axonal injury. The trial's primary objective is to evaluate the impact of 12 months of treatment with ATH434 on brain volume in advanced MSA patients. Final data from the trial are expected in the first half of 2025. ATH434 has previously been granted Orphan drug designation for the treatment of MSA by the U.S. FDA and the European Commission.
生物技术公司alterity therapeutics报道称，其用于治疗多系统萎缩症（MSA）的ATH434-202第二期临床试验取得了积极的中期数据。该试验仍在进行中，显示出令人鼓舞的结果，其中43%的参与者在接受ATH434治疗6个月后展现出日常生活活动的改善，29%的人表现出稳定或改善的神经症状。该药物也很耐受，没有报告与研究药物相关的严重不良事件。此外，临床反应者表现出生物标志物证据支持稳定的疾病，包括脑部铁的积累减少和轴突损伤标志物神经轻链的稳定水平。该试验的主要目标是评估ATH434治疗先进MSA患者12个月后对脑容积的影响。预计2025年上半年公布试验的最终数据。ATH434此前已获得美国FDA和欧洲委员会授予的用于MSA治疗的孤儿药物认定。
生物技术公司alterity therapeutics报道称，其用于治疗多系统萎缩症（MSA）的ATH434-202第二期临床试验取得了积极的中期数据。该试验仍在进行中，显示出令人鼓舞的结果，其中43%的参与者在接受ATH434治疗6个月后展现出日常生活活动的改善，29%的人表现出稳定或改善的神经症状。该药物也很耐受，没有报告与研究药物相关的严重不良事件。此外，临床反应者表现出生物标志物证据支持稳定的疾病，包括脑部铁的积累减少和轴突损伤标志物神经轻链的稳定水平。该试验的主要目标是评估ATH434治疗先进MSA患者12个月后对脑容积的影响。预计2025年上半年公布试验的最终数据。ATH434此前已获得美国FDA和欧洲委员会授予的用于MSA治疗的孤儿药物认定。
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