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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:外國發行人報告
美股SEC公告 ·  07/17 20:01
牛牛AI助理已提取核心訊息
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.
生物技術公司alterity therapeutics近日發佈了ATH434-202二期臨床試驗的階段性報告,治療多系統萎縮(MSA)的試驗目前仍在進行中。經過六個月的ATH434治療後,43%的參與者在日常生活活動中表現出改善,29%的參與者表現出神經症狀穩定或有所改善,結果令人鼓舞。未發現與研究藥物相關的嚴重不良事件,並且臨床反應者呈現穩定疾病的生物標誌物證據,包括大腦中鐵的積聚減少和軸索損傷標誌物神經元輕鏈穩定水平。該試驗的主要目標是評估ATH434 12個月治療對高級MSA患者的腦成交量的影響。預計在2025年上半年公佈最終數據。ATH434此前已被美國FDA和歐洲委員會授予孤兒藥物治療MSA的認定。
生物技術公司alterity therapeutics近日發佈了ATH434-202二期臨床試驗的階段性報告,治療多系統萎縮(MSA)的試驗目前仍在進行中。經過六個月的ATH434治療後,43%的參與者在日常生活活動中表現出改善,29%的參與者表現出神經症狀穩定或有所改善,結果令人鼓舞。未發現與研究藥物相關的嚴重不良事件,並且臨床反應者呈現穩定疾病的生物標誌物證據,包括大腦中鐵的積聚減少和軸索損傷標誌物神經元輕鏈穩定水平。該試驗的主要目標是評估ATH434 12個月治療對高級MSA患者的腦成交量的影響。預計在2025年上半年公佈最終數據。ATH434此前已被美國FDA和歐洲委員會授予孤兒藥物治療MSA的認定。

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