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6-K：外國發行人報告
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.
專注於開發神經退行性疾病治療方法的生物技術公司Alterity Therapeutics宣佈，獨立數據監測委員會（DMC）已建議按計劃繼續進行 ATH434-201 二期臨床試驗。該試驗正在研究 ATH434 對早期多系統萎縮 (MSA) 患者的療效，這是一種罕見的進行性神經退行性疾病，尚未獲得批准的減緩其進展的治療方法。DMC在對非盲臨床數據進行了第三次審查後，沒有發現任何安全問題，並在未經修改的情況下批准了正在進行的研究。該試驗預計將於2024年11月完成，頂線數據預計將於2025年1月完成。已被美國食品藥品管理局和歐盟委員會認定爲孤兒藥的 ATH434 也在另一項二期生物標誌物試驗中進行研究。當前的研究已招收了77名成人，旨在評估該藥物在12個月的治療期內對神經影像、蛋白質生物標誌物和臨床終點的影響。
專注於開發神經退行性疾病治療方法的生物技術公司Alterity Therapeutics宣佈，獨立數據監測委員會（DMC）已建議按計劃繼續進行 ATH434-201 二期臨床試驗。該試驗正在研究 ATH434 對早期多系統萎縮 (MSA) 患者的療效，這是一種罕見的進行性神經退行性疾病，尚未獲得批准的減緩其進展的治療方法。DMC在對非盲臨床數據進行了第三次審查後，沒有發現任何安全問題，並在未經修改的情況下批准了正在進行的研究。該試驗預計將於2024年11月完成，頂線數據預計將於2025年1月完成。已被美國食品藥品管理局和歐盟委員會認定爲孤兒藥的 ATH434 也在另一項二期生物標誌物試驗中進行研究。當前的研究已招收了77名成人，旨在評估該藥物在12個月的治療期內對神經影像、蛋白質生物標誌物和臨床終點的影響。
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