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.是一家在纳斯达克全球市场（NASDAQ:MNOV）和东京证券交易所标准市场（代码：4875）上市的生物制药公司，今天宣布关于公司MN-166（伊布利司特）在肌萎缩侧索硬化症（ALS）中的COMBAt-ALS II期/III期临床试验的研究更新和中期分析结果，将于2024年12月6日至8日在加拿大蒙特利尔举行的第35届国际ALS/MND研讨会上展示。
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:
该演讲的亮点标题为"COMBAt-ALS II期/III期MN-166（伊布利司特）在ALS中的试验更新和中期分析结果"（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名参与者入组，其中183名参与者被分配到MN-166或安慰剂组。
- 进行了预定义的中期分析，以评估6个月和12个月数据之间的相关性，并评估12个月双盲阶段试验设计。
- 来自全分析集的一部分患者在6个月时有ALSFRS-R数据，并且至少有一个6个月后数据点。评估在6个月和12个月时的综合功能和生存评估（CAFS）评分的相关性，以及修改后的CAFS评分和ALSFRS-R评分。
- 在CAFS评分（0.71）、修改后的CAFS评分（0.70）和ALSFRS-R（0.69）之间观察到了6个月和12个月数据的正相关。[注意：括号内的值为斯皮尔曼等级相关系数]
- 在Bulbar评分（0.74）、精细运动评分（0.71）和粗大运动评分（0.67）之间也观察到了正相关，但在呼吸评分中没有观察到正相关。[注意：括号内的值为斯皮尔曼等级相关系数]
- 中期分析结果经过外部独立的数据安全监督委员会（DSMB）审查和验证，建议按照协议继续进行试验。
