临床试验进展 - 公司正在进行一项针对轻度至中度阿尔茨海默病患者的2/3期LIFT-AD临床试验，预计在2024年第三季度公布试验的顶线数据[1][3][7] - LIFT-AD试验的主要终点指标是全局统计检验(GST)，这是一个综合认知(ADAS-Cog11)和功能(ADCS-ADL23)指标的复合指标，反映了整体疾病负担[8] - 公司正在进行一项ATH-1105的1期临床试验，评估其在健康受试者中的安全性、耐受性和药代动力学，预计在2024年底完成[10][11] - ATH-1105在多个ALS动物模型中显示出在神经和运动功能、炎症和神经变性生物标志物以及生存率方面的统计学显著改善[11] 财务状况 - 公司2024年第二季度的现金、现金等价物和投资总额为9180万美元[14] - 2024年第二季度研发费用为2220万美元，主要由ATH-1105项目费用增加所致[15] - 2024年第二季度一般及行政费用为590万美元，较上年同期下降[16]

核心观点 - Athira Pharma即将在2024年第三季度公布fosgonimeton治疗轻度至中度阿尔茨海默病的2/3期LIFT-AD临床试验顶线数据，并计划在10月的CTAD会议上进行口头报告[1][3] - 公司认为fosgonimeton可能成为首创新药(first-in-class)，通过调节HGF系统发挥神经保护作用，改善阿尔茨海默病的关键病理指标如pTau蛋白和神经退行性变[2][3] - 另一候选药物ATH-1105正在进行1期临床试验，用于治疗肌萎缩侧索硬化症(ALS)，预计2024年底完成[1][5][6] 临床开发进展 fosgonimeton (ATH-1017) - LIFT-AD试验已完成最后一名患者的给药，纳入约315名未接受背景治疗的轻度至中度AD患者，主要终点为综合认知(ADAS-Cog11)和功能(ADCS-ADL23)的GST评估[3] - 开放标签扩展研究(OLEX)中85%符合条件的患者选择继续参与，70多名患者治疗超过18个月，近50名超过24个月，显示出意外的长期参与率[4] - 临床前数据显示fosgonimeton可减轻β淀粉样蛋白诱导的自噬损伤，可能减少pTau病理，并与lecanemab联用显示神经保护作用[2][7] ATH-1105 - 正在健康志愿者中进行1期剂量递增试验，计划纳入80人，已完成首组给药，预计2024年底完成[5][6] - 临床前证据表明该药物能显著改善ALS模型的神经和运动功能、炎症和神经退行性变生物标志物及生存率[6] 财务表现 - 截至2024年6月30日，现金及等价物和投资为9180万美元，较2023年底的1.474亿美元减少[8][12] - 2024年第二季度研发支出2220万美元，同比略增，主要因ATH-1105试验启动；行政费用590万美元，同比下降[8][15] - 净亏损2690万美元(每股0.70美元)，较2023年同期的2960万美元(每股0.78美元)有所收窄[8][15] 近期学术活动 - 2024年7月在AAIC会议上展示fosgonimeton对自噬损伤和pTau病理的潜在作用[7] - 2024年6月举办专家研讨会，讨论LIFT-AD试验的GST终点设计[7]

Fosgonimeton mitigated amyloid-β-induced toxicity, lowered pTau levels and reduced disruption of protein clearance mechanisms that may contribute to pTau pathology Fosgonimeton treatment, alone and in combination with lecanemab, protected cultures of primary neurons from the toxic effects of amyloid-β BOTHELL, Wash., July 31, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ:ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow n ...

Athira Pharma, Inc (ATHA) recently announced that it has dosed the last patient in the phase II/III LIFT-AD study, which is evaluating its pipeline candidate, fosgonimeton for the treatment of mild-to-moderate Alzheimer’s disease (AD). Shares of the company were up 29.4%, following the announcement of the news.The LIFT-AD study evaluates once-daily fosgonimeton (40 mg) subcutaneous injection versus placebo over a treatment period of 26 weeks in mild-to-moderate AD patients. The study is designed to assess t ...

About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...

HIGHLIGHTS: Angilak Project: The Angilak Project is host to the Lac 50 Uranium Deposit, which is one of the largest high-grade deposits outside of the Athabasca Basin, with a historical mineral resource estimate of 43.3M lbs at an average grade of 0.69% U3O8.1In 2023, drilling at Angilak by Latitude Uranium (acquired by ATHA) intersected grades of up to 7.54 % U3O8 over 1.6 m.The 2024 Angilak Exploration Program is part of the Company’s overall 2024 Exploration Program and consists of Phase I (diamond drill ...

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

公司动态 - Athira Pharma将于2024年6月18日美东时间11:30举办网络研讨会，讨论fosgonimeton在轻中度阿尔茨海默病(AD)治疗中的潜在机会[1] - 研讨会将聚焦AD领域未满足的医疗需求，并解读LIFT-AD试验的主要终点指标Global Statistical Test(GST)[1] - 研讨会特邀两位神经退行性疾病领域专家：Pentara Corporation创始人Suzanne Hendrix博士和罗切斯特大学AD-CARE项目主任Anton P Porsteinsson博士[2] 临床试验进展 - 2/3期LIFT-AD试验预计2024年下半年公布顶线数据，该试验纳入约315名轻中度AD患者[1][4] - 试验采用26周随机双盲安慰剂对照设计，评估每日一次40mg皮下注射fosgonimeton的疗效[4] - 主要终点GST综合了认知功能(ADAS-Cog11)和日常生活能力(ADCS-ADL23)两个关键次要终点的结果[4] 药物研发 - Fosgonimeton是潜在first-in-class的每日一次皮下注射小分子药物，具有疾病修饰潜力[5] - 该药物通过调节神经营养HGF系统，靶向保护和修复神经元网络，适用于AD、帕金森病和路易体痴呆等多种神经退行性疾病[5][6] - 目前研发重点为轻中度AD治疗，LIFT-AD试验正在评估其对神经退行性变、蛋白病理和神经炎症等生物标志物的影响[4] 公司概况 - Athira Pharma总部位于华盛顿州西雅图地区，专注于通过小分子药物恢复神经元健康并延缓神经退行性病变[6] - 公司研发管线主要针对HGF神经营养系统调节剂，其中fosgonimeton进展最快[6] - 公司通过官网和社交媒体(Facebook、LinkedIn、X、Instagram)保持投资者沟通[7]

BOTHELL, Wash., June 11, 2024 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ:ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced that it has completed the first cohort of healthy volunteers in its ongoing, first-in-human, dose escalation Phase 1 clinical study evaluating ATH-1105, an oral, small molecule positive modulator of the neurotrophic hepatocyte growth factor (HGF) system in development f ...

SEATTLE, June 10, 2024 /PRNewswire/ -- Nacif, et al. v. Athira Pharma, Inc., et al., Case No: 2:21-cv-00861-TSZ (W.D. Wash).SUMMARY NOTICE OF (I) PENDENCY OF CLASS ACTION AND PROPOSED SETTLEMENT; (II) FINAL APPROVAL HEARING;AND (III) MOTION FOR AN AWARD OF ATTORNEYS' FEESAND PAYMENT OF LITIGATION EXPENSESTO: All persons and entities who or which purchased or otherwise acquired Athira Pharma, Inc. ("Athira") publicly traded common stock during the period from September 17, 2020, through June 17, 2021, inclus ...