MNOV: Encouraging Interim Analysis for Phase 2b/3 ALS Trial…

Zacks Small Cap Research12-09

By David Bautz, PhD NASDAQ:MNOV READ THE FULL MNOV RESEARCH REPORT Business Update Encouraging Interim Results from Phase 2b/3 COMBAT-ALS Trial On December 5, 2024, MediciNova, Inc. (NASDAQ:MNOV) ...

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(NASDAQ:MNOV) ...</p>\n\n<a href=\"https://finance.yahoo.com/news/mnov-encouraging-interim-analysis-phase-102600784.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4139","symbol_name":"生物科技","start_time":0,"source_url":"https://finance.yahoo.com/news/mnov-encouraging-interim-analysis-phase-102600784.html","article_id":"2490077284","we_media_id":null,"thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2490077284","pubTimestamp":1733739960,"columns":[],"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"Encouraging Interim Results from Phase 2b/3 COMBAT-ALS Trial. On December 5, 2024, MediciNova, Inc.  announced a poster presentation at the 35th International Symposium on ALS/MND would feature a study update and interim analysis results from the ongoing Phase 2b/3 COMBAT-ALS trial of MN-166 .As of November 15, 2024, the trial has enrolled a total of 217 participants and 183 participants have been randomly assigned to treatment with either placebo or MN-166. A pre-defined interim analysis was performed to evaluate the correlation between the 6-month and 12-month data as well as assessing the 12-month double blind phase trial design. A correlation analysis was performed on the  scores, modified CAFS scores, and ALSFRS-R scores at six and 12 months.SUBSCRIBE TO ZACKS SMALL CAP RESEARCHtoreceive our articles and reports emailed directly to you each morning. Please visit ourwebsitefor additional information on Zacks SCR.","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4139":"生物科技","CAFS":"Cafe Serendipity Holdings, Inc.","MNOV":"美第奇新星生物技术"},"translate_title":"MNOV：令人鼓舞的2b/3期ALS试验中期分析……","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"CAFS":1,"MNOV":1},"content_text":"By David Bautz, PhD\n NASDAQ:MNOV\nREAD THE FULL MNOV RESEARCH REPORT\nBusiness Update\nEncouraging Interim Results from Phase 2b/3 COMBAT-ALS Trial\nOn December 5, 2024, MediciNova, Inc. (NASDAQ:MNOV) announced a poster presentation at the 35th International Symposium on ALS/MND would feature a study update and interim analysis results from the ongoing Phase 2b/3 COMBAT-ALS trial of MN-166 (ibudilast).\nAs of November 15, 2024, the trial has enrolled a total of 217 participants and 183 participants have been randomly assigned to treatment with either placebo or MN-166. A pre-defined interim analysis was performed to evaluate the correlation between the 6-month and 12-month data as well as assessing the 12-month double blind phase trial design. A correlation analysis was performed on the (CAFS) scores, modified CAFS scores, and ALSFRS-R scores at six and 12 months.\nThere was a positive correlation for the 6- and 12-month data for CAFS score (0.71), modified CAFS score (0.70), and ALSFRS-R (0.69). The numbers in parentheses represent Spearman Rank Correlation coefficients, which indicates the strength and direction between two sets of data. In practical terms, a coefficient of 0.7 indicates a strong, positive correlation. Positive correlations were also seen for Bulbar score (0.74), fine motor score (0.71), and gross motor score (0.67), however no correlation was seen for respiratory score. Overall, these data support the company’s use of a 12-month, double blind trial design. This was further validated by the Data Safety Monitoring Board (DSMB), which reviewed the data and recommended that the trial continue as per protocol.\nBased on the current enrollment rate, we estimate that the trial will be fully enrolled by mid-2025, which would lead to release of topline results in 2026.\nIn addition to the COMBAT-ALS trial, we anticipate the initiation of an Expanded Access Protocol (EAP) trial to evaluate the effect of MN-166 treatment on blood levels of neurofilament light (NfL) in patients with ALS in 2025. That trial is being supported by a $22 million grant from the National Institutes of Health (NIH) – Neurological Disorders and Stroke (NINDS) with MediciNova providing drug product, regulatory support, and safety monitoring support.\nConclusion\nThe encouraging update on the Phase 2b/3 COMBAT-ALS trial is a good sign for the company as it moves to finish enrollment in the trial by mid-2025. It’s not possible to draw any conclusions regarding the efficacy of MN-166 from the data, however a positive correlation between the 6- and 12-month data is indicative that it will be a robust data set. Assuming the trial can be fully enrolled by mid-2025 we anticipate topline results in 2026. With no changes to our model, our valuation remains at $10 per share.\nSUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. \n \nDISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.3","shortVersion":"4.29.3","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2490077284"}