Novo Nordisk's Hemophilia Candidate Can Prevent Bleeding Episodes Effectively, Regardless Of Dosing Frequency
Novo Nordisk's Hemophilia Candidate Can Prevent Bleeding Episodes Effectively, Regardless Of Dosing Frequency
Monday, Novo Nordisk A/S (NYSE:NVO) released headline results from the FRONTIER 2 Phase 3a trial of once-weekly and once-monthly subcutaneous Mim8 versus no prophylaxis and versus prior coagulation factor prophylaxis treatment in hemophilia A patients 12 years or older with or without inhibitors.
週一，Novo Nordisk A/S（紐約證券交易所代碼：NVO）公佈了FRONTIER 2期3a期試驗的總體結果，該試驗針對的是每週一次和每月一次的皮下Mim8對比不進行預防，對比先前的凝血因子預防治療，對比12歲或以上有抑制劑或不使用抑制劑的A型血友病患者。
The trial achieved its co-primary endpoints by demonstrating a statistically significant and superior reduction of treated bleeding episodes with both once-weekly and once-monthly Mim8 versus no prophylaxis treatment and prior coagulation factor prophylaxis treatment.
該試驗表明，與未進行預防治療和先前使用凝血因子預防治療相比，每週一次和每月一次的Mim8可以顯著減少治療的出血發作，從而實現了其共同主要終點。
In people with no prior prophylaxis treatment, once-weekly and once-monthly Mim8 demonstrated superior reductions of 97% and 99% in treated bleeds, respectively, compared to those who received no prophylaxis treatment.
在未接受預防治療的人群中，與未接受預防治療的患者相比，每週一次和每月一次的Mim8的出血量分別減少了97％和99％。
In addition, 86% of people treated with once-weekly Mim8 and 95% of those treated with once-monthly Mim8 experienced zero treated bleeds, compared to 0% of those treated with no prophylaxis.
此外，在每週接受一次Mim8治療的患者中，有86％和每月接受一次Mim8治療的患者中有95％的出血治療爲零，而未接受預防治療的患者中，這一比例爲0％。
In the intra-patient analysis in people with prior coagulation factor prophylaxis, once-weekly and once-monthly Mim8 demonstrated superior reductions of 48% and 43% in treated bleeds, respectively, compared to prior coagulation factor prophylaxis.
在對先前接受過凝血因子預防的患者的住院分析中，與之前的凝血因子預防相比，每週一次和每月一次的Mim8顯示，與之前的凝血因子預防相比，治療後的出血量分別減少了48％和43％。
Additionally, 66% of people treated with once-weekly Mim8 and 65% of people treated with once-monthly Mim8 experienced zero treated bleeds.
此外，在每週接受一次Mim8治療的人中，有66％的人和每月接受一次Mim8治療的患者中有65％的出血治療爲零。
In the trial, Mim8 appeared to have a safe and well-tolerated profile in line with previous trials. No deaths or thromboembolic events were reported in the trial.
在試驗中，Mim8似乎具有安全且耐受性良好的特徵，與先前的試驗一致。試驗中未報告死亡或血栓栓塞事件。
Novo Nordisk aims to submit Mim8 for the first regulatory approval towards the end of 2024.
諾和諾德的目標是在2024年底之前提交Mim8以獲得監管部門的首次批准。
Data from the phase 3 FRONTIER program, including FRONTIER 2 will be disclosed at upcoming congresses and in publications in 2024 and 2025.
包括FRONTIER 2在內的第三階段FRONTIER計劃的數據將在即將舉行的大會上以及2024年和2025年的出版物中披露。
Hemophilia is a rare inherited bleeding disorder that impairs the body's ability to make blood clots, a process needed to stop bleeding. It is estimated to affect approximately 1,125,000 people worldwide, and hemophilia A accounts for 80-85% of all hemophilia cases.
血友病是一種罕見的遺傳性出血性疾病，會損害人體形成血塊的能力，而血栓是止血所必需的過程。據估計，它影響全球約112.5萬人，A型血友病佔所有血友病病例的80-85％。
Price Action: NVO shares are up 3.04% at $132.33 at last check Monday.
價格走勢：週一最後一次檢查時，NVO股價上漲3.04％，至132.33美元。
Photo via Shutterstock
照片來自 Shutterstock
譯文內容由第三人軟體翻譯。