AC Immune's Active Immunotherapy Shows Antibody Responses In Early Parkinson's Patients
AC Immune's Active Immunotherapy Shows Antibody Responses In Early Parkinson's Patients
Part 1 includes initial analyses from over 30 patients randomized to receive ACI-7104.56 or placebo.AC Immune SA (NASDAQ:ACIU) revealed data from a Phase 2 clinical trial of its wholly owned anti-alpha-synuclein (a-syn) active immunotherapy candidate for early Parkinson's disease.
AC Immune SA (納斯達克:ACIU)公佈了其完全擁有的抗α-突觸核蛋白(a-syn)主動免疫療法候選藥物在早期帕金森病中的二期臨床試驗數據。
Dr. Andrea Pfeifer, CEO of AC Immune, commented: "The level of immunogenicity after only 3 months of treatment as well as the continued positive safety profile, reinforces the best-in-class characteristics of our clinically validated anti-a-syn active immunotherapy for the treatment of Parkinson's disease. We look forward to sharing further updates in H1 2025 including the decision to expand into Part 2 of the VacSYn study."
AC Immune的首席執行官安德烈亞·菲弗博士評論道：「經過僅3個月的治療後，免疫原性水平以及持續的積極安全性特徵，鞏固了我們經過臨床驗證的治療帕金森病的抗a-syn主動免疫療法的最佳特性。我們期待在2025年上半年分享更多更新，包括擴大VacSYn研究第二部分的決定。」
VacSYn is an adaptive, placebo-controlled, and biomarker-based Phase 2 study in patients with early PD, consisting of two parts.
VacSYn是一個適應性、安慰劑對照和基於生物標誌物的早期PD患者的二期研究，分爲兩個部分。
Part 1 includes initial analyses from over 30 patients randomized to receive ACI-7104.56 or placebo.
第一部分包括來自30多名患者的初步分析，這些患者被隨機分配接受ACI-7104.56或安慰劑。
To date, no clinically relevant safety issues have been reported other than transient injection site reactions (49%) and headaches (18%).
迄今爲止，除了短暫的注射部位反應（49%）和頭痛（18%）外，沒有報告臨床相關的安全問題。
Interim results show positive antibody responses were effectively induced against the target antigen at week 6 after two immunizations and were strongly boostable.
中期結果顯示，經過兩次免疫接種後，在第6周對靶抗原的陽性抗體反應被有效誘導，並且反應具有強烈的可增強性。
Treatment with the candidate, ACI-7104.056, induced an increase in anti-a-syn antibodies on average 16-fold higher than the placebo background level after three immunizations.
候選藥物ACI-7104.056的治療使抗a-syn抗體平均增加到比安慰劑背景水平高16倍以上，經過三次免疫接種後。
Based on further interim results, including pharmacodynamic data, to be reported in H1 2025, AC Immune may decide to initiate Part 2 of VacSYn with up to 150 patients.
根據進一步的中期結果，包括將在2025年上半年報告的藥效學數據，AC Immune可能決定啓動VacSYn的第二部分，最多可招募150名患者。
Patients from Part 2 will also be evaluated for the progression of motor and non-motor symptoms of the disease, as well as digital, imaging, and fluid biomarkers.
第二部分的患者將評估疾病的運動和非運動症狀的進展，以及數字、生物成像和體液生物標誌物。
In May, Takeda Pharmaceutical Company Limited (NYSE:TAK) and AC Immune announced an exclusive, worldwide option and license agreement for AC Immune's active immunotherapies targeting toxic forms of amyloid beta (Abeta), including ACI-24.060 for Alzheimer's disease.
在五月，武田製藥有限公司（紐交所代碼：TAK）與ac immune宣佈達成獨家全球選項和許可協議，針對有毒形式的澱粉樣β（Abeta）的ac immune活性免疫治療，包括用於阿爾茨海默病的ACI-24.060。
Price Action: AC Immune stock is up 6.71% at $3.34 during the premarket session at last check Thursday.
價格動態：ac immune股票在週四盤前交易時上漲6.71%，報3.34美元。
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譯文內容由第三人軟體翻譯。
