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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 ·  05/09 13:19
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Alterity Therapeutics, a biotechnology company focused on developing treatments for neurodegenerative diseases, announced that the independent Data Monitoring Committee (DMC) has recommended the continuation of the ATH434-201 Phase 2 clinical trial as planned. This trial is investigating the efficacy of ATH434 in patients with early-stage multiple system atrophy (MSA), a rare and progressive neurodegenerative disease with no approved treatments to slow its progression. The DMC, after its third review of unblinded clinical data, found no safety concerns and endorsed the ongoing study without modifications. The trial is expected to be completed in November 2024, with top-line data anticipated in January 2025. ATH434, which has been granted Orphan drug designation by the U.S. FDA and the European Commission, is also being studied in a separate Phase 2 Biomarker trial. The current study has enrolled 77 adults and aims to assess the drug's impact on neuroimaging, protein biomarkers, and clinical endpoints over a 12-month treatment period.
Alterity Therapeutics, a biotechnology company focused on developing treatments for neurodegenerative diseases, announced that the independent Data Monitoring Committee (DMC) has recommended the continuation of the ATH434-201 Phase 2 clinical trial as planned. This trial is investigating the efficacy of ATH434 in patients with early-stage multiple system atrophy (MSA), a rare and progressive neurodegenerative disease with no approved treatments to slow its progression. The DMC, after its third review of unblinded clinical data, found no safety concerns and endorsed the ongoing study without modifications. The trial is expected to be completed in November 2024, with top-line data anticipated in January 2025. ATH434, which has been granted Orphan drug designation by the U.S. FDA and the European Commission, is also being studied in a separate Phase 2 Biomarker trial. The current study has enrolled 77 adults and aims to assess the drug's impact on neuroimaging, protein biomarkers, and clinical endpoints over a 12-month treatment period.
专注于开发神经退行性疾病治疗方法的生物技术公司Alterity Therapeutics宣布，独立数据监测委员会（DMC）已建议按计划继续进行 ATH434-201 二期临床试验。该试验正在研究 ATH434 对早期多系统萎缩 (MSA) 患者的疗效，这是一种罕见的进行性神经退行性疾病，尚未获得批准的减缓其进展的治疗方法。DMC在对非盲临床数据进行了第三次审查后，没有发现任何安全问题，并在未经修改的情况下批准了正在进行的研究。该试验预计将于2024年11月完成，顶线数据预计将于2025年1月完成。已被美国食品药品管理局和欧盟委员会认定为孤儿药的 ATH434 也在另一项二期生物标志物试验中进行研究。当前的研究已招收了77名成人，旨在评估该药物在12个月的治疗期内对神经影像、蛋白质生物标志物和临床终点的影响。
专注于开发神经退行性疾病治疗方法的生物技术公司Alterity Therapeutics宣布，独立数据监测委员会（DMC）已建议按计划继续进行 ATH434-201 二期临床试验。该试验正在研究 ATH434 对早期多系统萎缩 (MSA) 患者的疗效，这是一种罕见的进行性神经退行性疾病，尚未获得批准的减缓其进展的治疗方法。DMC在对非盲临床数据进行了第三次审查后，没有发现任何安全问题，并在未经修改的情况下批准了正在进行的研究。该试验预计将于2024年11月完成，顶线数据预计将于2025年1月完成。已被美国食品药品管理局和欧盟委员会认定为孤儿药的 ATH434 也在另一项二期生物标志物试验中进行研究。当前的研究已招收了77名成人，旨在评估该药物在12个月的治疗期内对神经影像、蛋白质生物标志物和临床终点的影响。
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