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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 ·  10/02 08:04

Moomoo AI 已提取核心信息

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.
生物技术公司Alterity Therapeutics有望在其首选候选药ATH434上取得重要进展,作为多系统萎缩(MSA)的潜在疾病修饰治疗。2024年10月2日举行的国际帕金森病和运动障碍大会期间,公司展示了来自正在进行的临床试验的多组数据。ATH434-202阶段2开放标签临床试验证明了令人鼓舞的结果,其中30%的参与者表现出稳定或改善的临床结局。这些“临床反应者”还表现出客观生物标志物的稳定性,如大脑铁水平和神经损伤的蛋白标记。公司还分享了ATH434-201随机、双盲临床试验的基线数据,该试验评估了早期MSA患者的ATH434。在大会上呈报的数据支持ATH434有潜力修饰疾病进展,并减轻MSA患者的残疾。ATH434已被美国FDA和欧洲委员会授予孤儿药物认定,用于治疗MSA。预计ATH434-201试验的首要数据将于2025年1月公布,ATH434-202试验的12个月数据将在同年晚些时候公布。
生物技术公司Alterity Therapeutics有望在其首选候选药ATH434上取得重要进展,作为多系统萎缩(MSA)的潜在疾病修饰治疗。2024年10月2日举行的国际帕金森病和运动障碍大会期间,公司展示了来自正在进行的临床试验的多组数据。ATH434-202阶段2开放标签临床试验证明了令人鼓舞的结果,其中30%的参与者表现出稳定或改善的临床结局。这些“临床反应者”还表现出客观生物标志物的稳定性,如大脑铁水平和神经损伤的蛋白标记。公司还分享了ATH434-201随机、双盲临床试验的基线数据,该试验评估了早期MSA患者的ATH434。在大会上呈报的数据支持ATH434有潜力修饰疾病进展,并减轻MSA患者的残疾。ATH434已被美国FDA和欧洲委员会授予孤儿药物认定,用于治疗MSA。预计ATH434-201试验的首要数据将于2025年1月公布,ATH434-202试验的12个月数据将在同年晚些时候公布。
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