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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 ·  10/02 08:04

Moomoo AI 已提取核心訊息

Alterity Therapeutics Limited, a biotechnology company, has made significant strides in the development of its lead candidate, ATH434, as a potential disease-modifying treatment for Multiple System Atrophy (MSA). During the International Congress of Parkinson’s Disease and Movement Disorders held on October 2, 2024, the company presented multiple data sets from its ongoing clinical trials. The ATH434-202 Phase 2 open-label clinical trial showed promising results, with 30% of participants demonstrating stable or improved clinical outcomes. These 'clinical responders' also exhibited stability in objective biomarkers such as brain iron levels and a protein marker of nerve damage. The company also shared baseline data from the ATH434-201 randomized, double-blind clinical trial, which is evaluating ATH434 in patients with early-stage MSA. The data presented at the congress...Show More
Alterity Therapeutics Limited, a biotechnology company, has made significant strides in the development of its lead candidate, ATH434, as a potential disease-modifying treatment for Multiple System Atrophy (MSA). During the International Congress of Parkinson’s Disease and Movement Disorders held on October 2, 2024, the company presented multiple data sets from its ongoing clinical trials. The ATH434-202 Phase 2 open-label clinical trial showed promising results, with 30% of participants demonstrating stable or improved clinical outcomes. These 'clinical responders' also exhibited stability in objective biomarkers such as brain iron levels and a protein marker of nerve damage. The company also shared baseline data from the ATH434-201 randomized, double-blind clinical trial, which is evaluating ATH434 in patients with early-stage MSA. The data presented at the congress supports the potential of ATH434 to modify disease progression and reduce disability in individuals with MSA. ATH434 has been granted Orphan drug designation by the U.S. FDA and the European Commission for the treatment of MSA. Topline data from the ATH434-201 trial is expected in January 2025, with 12-month data from the ATH434-202 trial anticipated later that year.
生物技術公司alterity therapeutics取得了重大進展,其主力候選藥物ATH434有望成爲多系統萎縮症(MSA)的潛在疾病修飾治療。在2024年10月2日舉行的國際帕金森病與運動障礙大會期間,公司展示了其正在進行中的臨床試驗的多個數據集。ATH434-202期2期開放標籤臨床試驗顯示了令人振奮的結果,30%的參與者表現出穩定或改善的臨床結果。這些「臨床反應者」還表現出客觀生物標誌物(如腦鐵水平和神經損傷的蛋白標誌物)的穩定性。該公司還分享了ATH434-201隨機、雙盲臨床試驗的基線數據,該試驗評估了早期MSA患者的ATH434。大會上展示的數據支持了ATH434修改疾病進展、減輕患有MSA的人的殘疾風險的潛力。ATH434已獲得美國FDA和歐洲委員會針對MSA治療的孤兒藥物認定。ATH434-201試驗的頭條數據預計將於2025年1月公佈,ATH434-202試驗的12個月數據預計將在同年晚些時候公佈。
生物技術公司alterity therapeutics取得了重大進展,其主力候選藥物ATH434有望成爲多系統萎縮症(MSA)的潛在疾病修飾治療。在2024年10月2日舉行的國際帕金森病與運動障礙大會期間,公司展示了其正在進行中的臨床試驗的多個數據集。ATH434-202期2期開放標籤臨床試驗顯示了令人振奮的結果,30%的參與者表現出穩定或改善的臨床結果。這些「臨床反應者」還表現出客觀生物標誌物(如腦鐵水平和神經損傷的蛋白標誌物)的穩定性。該公司還分享了ATH434-201隨機、雙盲臨床試驗的基線數據,該試驗評估了早期MSA患者的ATH434。大會上展示的數據支持了ATH434修改疾病進展、減輕患有MSA的人的殘疾風險的潛力。ATH434已獲得美國FDA和歐洲委員會針對MSA治療的孤兒藥物認定。ATH434-201試驗的頭條數據預計將於2025年1月公佈,ATH434-202試驗的12個月數據預計將在同年晚些時候公佈。
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