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6-K: Once-Weekly and Once-Monthly Mim8 Demonstrate Superior Reduction of Treated Bleeding Episodes Compared to On-Demand and Prior Prophylaxis Treatment in People with Haemophilia a in the Frontier 2 Trial

6-K: Once-Weekly and Once-Monthly Mim8 Demonstrate Superior Reduction of Treated Bleeding Episodes Compared to On-Demand and Prior Prophylaxis Treatment in People with Haemophilia a in the Frontier 2 Trial

6-K: 在Frontier 2試驗中，與按需和先前的預防治療相比，每週一次和每月一次的Mim8顯示出血發作明顯減少
美股sec公告 ·  05/14 00:54
牛牛AI助理已提取核心訊息
On May 13, 2024, Novo Nordisk A/S announced positive results from the FRONTIER 2 trial, a phase 3a study evaluating the efficacy and safety of Mim8, a prophylactic treatment for haemophilia A. The trial, which included 254 participants aged 12 and older, demonstrated that both once-weekly and once-monthly subcutaneous injections of Mim8 significantly reduced treated bleeding episodes compared to no prophylaxis and prior coagulation factor prophylaxis treatments. The study met its co-primary endpoints, with once-weekly and once-monthly Mim8 showing reductions of 97% and 99% in treated bleeds, respectively, in participants without prior prophylaxis. Additionally, a majority of participants experienced zero treated bleeds. The intra-patient analysis also revealed substantial reductions in treated bleeds compared to prior prophylaxis. Mim8 was well-tolerated with no reported deaths or...Show More
On May 13, 2024, Novo Nordisk A/S announced positive results from the FRONTIER 2 trial, a phase 3a study evaluating the efficacy and safety of Mim8, a prophylactic treatment for haemophilia A. The trial, which included 254 participants aged 12 and older, demonstrated that both once-weekly and once-monthly subcutaneous injections of Mim8 significantly reduced treated bleeding episodes compared to no prophylaxis and prior coagulation factor prophylaxis treatments. The study met its co-primary endpoints, with once-weekly and once-monthly Mim8 showing reductions of 97% and 99% in treated bleeds, respectively, in participants without prior prophylaxis. Additionally, a majority of participants experienced zero treated bleeds. The intra-patient analysis also revealed substantial reductions in treated bleeds compared to prior prophylaxis. Mim8 was well-tolerated with no reported deaths or thromboembolic events. Novo Nordisk plans to seek regulatory approval for Mim8 by the end of 2024, with further data from the FRONTIER programme to be presented at upcoming congresses and in publications. Haemophilia A is a rare bleeding disorder affecting around 1,125,000 people globally, and Mim8 offers a new prophylactic option for those living with the condition, with or without inhibitors.
2024年5月13日，Novo Nordisk A/S宣佈了FRONTIER 2試驗的積極結果，這是一項評估甲型血友病預防性治療藥物Mim8的療效和安全性的3a期研究。該試驗包括254名年齡在12歲及以上的參與者，表明，與未採取預防措施和先前的凝血因子相比，每週一次和每月一次的皮下注射Mim8都能顯著減少治療的出血發作預防治療。該研究達到了共同的主要終點，每週一次和每月一次的Mim8顯示，在沒有事先預防的情況下，受試者的治療出血量分別減少了97％和99％。此外，大多數參與者的出血治療爲零。患者內分析還顯示，與先前的預防相比，經過治療的出血量大幅減少。Mim8 耐受性良好，沒有報告死亡或血栓栓塞事件。諾和諾德計劃在2024年底之前尋求監管部門對Mim8的批准，來自FRONTIER計劃的更多數據將在即將舉行的會議和出版物中公佈。甲型血友病是一種罕見的出血性疾病，影響全球約112.5萬人，Mim8爲該病患者提供了一種新的預防選擇，無論是否使用抑制劑。
2024年5月13日，Novo Nordisk A/S宣佈了FRONTIER 2試驗的積極結果，這是一項評估甲型血友病預防性治療藥物Mim8的療效和安全性的3a期研究。該試驗包括254名年齡在12歲及以上的參與者，表明，與未採取預防措施和先前的凝血因子相比，每週一次和每月一次的皮下注射Mim8都能顯著減少治療的出血發作預防治療。該研究達到了共同的主要終點，每週一次和每月一次的Mim8顯示，在沒有事先預防的情況下，受試者的治療出血量分別減少了97％和99％。此外，大多數參與者的出血治療爲零。患者內分析還顯示，與先前的預防相比，經過治療的出血量大幅減少。Mim8 耐受性良好，沒有報告死亡或血栓栓塞事件。諾和諾德計劃在2024年底之前尋求監管部門對Mim8的批准，來自FRONTIER計劃的更多數據將在即將舉行的會議和出版物中公佈。甲型血友病是一種罕見的出血性疾病，影響全球約112.5萬人，Mim8爲該病患者提供了一種新的預防選擇，無論是否使用抑制劑。
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