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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 08:01
Moomoo AI 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報告其ATH434-202 II期臨床試驗治療多系統萎縮症(MSA)的積極中期數據。儘管該試驗仍在進行中,但經過6個月的ATH434治療,43%的參與者表現出日常生活活動的改善,29%表現出穩定或改善的神經症狀,顯示出鼓舞人心的結果。藥物耐受性良好,沒有報告與研究藥物相關的嚴重不良事件。此外,臨床治療反應者表現出穩定疾病的生物標誌證據,包括腦鐵積累的減少和軸突損傷標誌物神經絲輕鏈水平的穩定。該試驗的主要目標是評估ATH434治療晚期MSA患者12個月對腦容積的影響。預計該試驗的最終數據將在2025年上半年公佈。ATH434此前已被美國FDA和歐洲委員會批准作爲MSA治療孤兒藥物。
生物技術公司alterity therapeutics報告其ATH434-202 II期臨床試驗治療多系統萎縮症(MSA)的積極中期數據。儘管該試驗仍在進行中,但經過6個月的ATH434治療,43%的參與者表現出日常生活活動的改善,29%表現出穩定或改善的神經症狀,顯示出鼓舞人心的結果。藥物耐受性良好,沒有報告與研究藥物相關的嚴重不良事件。此外,臨床治療反應者表現出穩定疾病的生物標誌證據,包括腦鐵積累的減少和軸突損傷標誌物神經絲輕鏈水平的穩定。該試驗的主要目標是評估ATH434治療晚期MSA患者12個月對腦容積的影響。預計該試驗的最終數據將在2025年上半年公佈。ATH434此前已被美國FDA和歐洲委員會批准作爲MSA治療孤兒藥物。
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