MediciNova Presents Study Update And Interim Analysis Of Phase 2/3 Clinical Trial Of MN-166 In ALS At The 35th International Symposium On ALS/MND
MediciNova Presents Study Update And Interim Analysis Of Phase 2/3 Clinical Trial Of MN-166 In ALS At The 35th International Symposium On ALS/MND
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announces the study update and interim analysis results from the Company's COMBAT-ALS Phase 2b/3 clinical trial of MN-166 (ibudilast) in Amyotrophic Lateral Sclerosis (ALS) will be presented at the 35th International Symposium on ALS/MND held December 6-8, 2024 in Montreal, Canada.
MediciNova, Inc.是一家在納斯達克全球市場（NASDAQ:MNOV）和東京證券交易所標準市場（代碼：4875）上市的生物製藥公司，今天宣佈關於公司MN-166（伊布利司特）在肌萎縮側索硬化症（ALS）中的COMBAt-ALS II期/III期臨床試驗的研究更新和中期分析結果，將於2024年12月6日至8日在加拿大蒙特利爾舉行的第35屆國際ALS/MND研討會上展示。
The highlights of the presentation, titled, "COMBAT-ALS Phase 2b/3 Trial of MN-166 (Ibudilast) in ALS: Trial Update and Interim Analysis Results" (Abstract # 302), include:
該演講的亮點標題爲"COMBAt-ALS II期/III期MN-166（伊布利司特）在ALS中的試驗更新和中期分析結果"（摘要#302），包括：
- Study Update: As of November 15, 2024, a total of 217 participants have been enrolled and 183 participants were assigned to either MN-166 or placebo group.
- Pre-defined interim analysis was conducted to evaluate the correlation between the 6-month and 12-month data and assess the 12-month double-blind phase trial design.
- A subset of patients from the full analysis set who had ALSFRS-R data at 6 months and at least one post-6-month data point. Correlation analysis of the Combined Assessment of Function and Survival (CAFS) scores at 6 and 12 months as well as modified CAFS scores and ALSFRS-R scores were evaluated.
- Positive correlations were observed between the 6-month and 12-month data for CAFS score (0.71), modified CAFS score (0.70), and ALSFRS-R (0.69). [Note: Values in parentheses are Spearman Rank Correlation coefficients]
- Positive correlations were also observed for Bulbar score (0.74), Fine motor score (0.71), and Gross motor score (0.67), but not for Respiratory score. [Note: Values in parentheses are Spearman Rank Correlation coefficients]
- Interim analysis results were reviewed and validated by an external independent Data Safety Monitoring Board (DSMB), which recommended that the trial continue as per the protocol.
- 研究更新：截至2024年11月15日，共有217名參與者入組，其中183名參與者被分配到MN-166或安慰劑組。
- 進行了預定義的中期分析，以評估6個月和12個月數據之間的相關性，並評估12個月雙盲階段試驗設計。
- 來自全分析集的一部分患者在6個月時有ALSFRS-R數據，並且至少有一個6個月後數據點。評估在6個月和12個月時的綜合功能和生存評估（CAFS）評分的相關性，以及修改後的CAFS評分和ALSFRS-R評分。
- 在CAFS評分（0.71）、修改後的CAFS評分（0.70）和ALSFRS-R（0.69）之間觀察到了6個月和12個月數據的正相關。[注意：括號內的值爲斯皮爾曼等級相關係數]
- 在Bulbar評分（0.74）、精細運動評分（0.71）和粗大運動評分（0.67）之間也觀察到了正相關，但在呼吸評分中沒有觀察到正相關。[注意：括號內的值爲斯皮爾曼等級相關係數]
- 中期分析結果經過外部獨立的數據安全監督委員會（DSMB）審查和驗證，建議按照協議繼續進行試驗。
譯文內容由第三人軟體翻譯。
