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Tonix Pharmaceuticals | 8-K: Tonix Pharmaceuticals Holding Corp. Announced the Presentation of Additional Efficacy Data from the Phase 3 Resilient Study

Tonix Pharmaceuticals | 8-K：Tonix Pharmaceuticals公佈Resilient第三階段研究的更多功效數據

SEC announcement ·  03/11 20:06
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On March 11, 2024, Tonix Pharmaceuticals Holding Corp. announced positive additional efficacy data from the Phase 3 RESILIENT study of its product candidate Tonmya, for the management of fibromyalgia, at the 6th International Congress on Controversies in Fibromyalgia. The study met its primary endpoint of daily pain reduction and achieved statistically significant improvement on all six key pre-specified secondary endpoints with effect sizes ranging from 0.3 to 0.5. Notably, the treatment resulted in an improvement in cognitive dysfunction, commonly referred to as 'brain fog', as measured by the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) memory item. The company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024, following a pre-NDA meeting...Show More
On March 11, 2024, Tonix Pharmaceuticals Holding Corp. announced positive additional efficacy data from the Phase 3 RESILIENT study of its product candidate Tonmya, for the management of fibromyalgia, at the 6th International Congress on Controversies in Fibromyalgia. The study met its primary endpoint of daily pain reduction and achieved statistically significant improvement on all six key pre-specified secondary endpoints with effect sizes ranging from 0.3 to 0.5. Notably, the treatment resulted in an improvement in cognitive dysfunction, commonly referred to as 'brain fog', as measured by the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) memory item. The company plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2024, following a pre-NDA meeting with the FDA scheduled for the second quarter of 2024. Tonix's CEO, Seth Lederman, highlighted the broad-spectrum activity of Tonmya, suggesting it treats fibromyalgia at a syndromal level. The RESILIENT study, which enrolled 457 participants across 33 sites in the U.S., demonstrated that Tonmya was well-tolerated with the most common adverse events being transient and self-limited local administration site reactions.
2024年3月11日，Tonix Pharmicals Holding Corp. 在第六屆纖維肌痛爭議國際大會上公佈了其候選產品Tonmya針對纖維肌痛管理的3期彈性研究的積極額外療效數據。該研究達到了每日減輕疼痛的主要終點，並且在預先指定的所有六個關鍵次要終點上取得了統計學上的顯著改善，效果大小範圍從0.3到0.5不等。值得注意的是，根據纖維肌痛影響問卷修訂版（FIQ-R）記憶項目測量，該治療改善了認知功能障礙，通常被稱爲 “腦霧”。繼計劃於2024年第二季度與美國食品藥品監督管理局（FDA）舉行保密協議前會議之後，該公司計劃在2024年下半年向美國食品藥品監督管理局（FDA）提交新藥申請（NDA）。Tonix首席執行官塞思·萊德曼強調了Tonmya的廣譜活性，建議它在綜合徵層面上治療纖維肌痛。這項彈性研究招收了來自美國33個地點的457名參與者，該研究表明，Tonmya的耐受性良好，最常見的不良事件是短暫和自限性的地方給藥部位反應。
2024年3月11日，Tonix Pharmicals Holding Corp. 在第六屆纖維肌痛爭議國際大會上公佈了其候選產品Tonmya針對纖維肌痛管理的3期彈性研究的積極額外療效數據。該研究達到了每日減輕疼痛的主要終點，並且在預先指定的所有六個關鍵次要終點上取得了統計學上的顯著改善，效果大小範圍從0.3到0.5不等。值得注意的是，根據纖維肌痛影響問卷修訂版（FIQ-R）記憶項目測量，該治療改善了認知功能障礙，通常被稱爲 “腦霧”。繼計劃於2024年第二季度與美國食品藥品監督管理局（FDA）舉行保密協議前會議之後，該公司計劃在2024年下半年向美國食品藥品監督管理局（FDA）提交新藥申請（NDA）。Tonix首席執行官塞思·萊德曼強調了Tonmya的廣譜活性，建議它在綜合徵層面上治療纖維肌痛。這項彈性研究招收了來自美國33個地點的457名參與者，該研究表明，Tonmya的耐受性良好，最常見的不良事件是短暫和自限性的地方給藥部位反應。
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