After Failed COVID-19 Drug Trial, Atea Pharmaceuticals Touts Encouraging Data From Mid-Stage Hepatitis C Study
After Failed COVID-19 Drug Trial, Atea Pharmaceuticals Touts Encouraging Data From Mid-Stage Hepatitis C Study
On Wednesday, Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) released Phase 2 study data from the regimen of bemnifosbuvir and ruzasvir for the hepatitis C virus infection that causes liver swelling and can lead to serious liver damage.
在週三,atea pharmaceuticals(納斯達克:AVIR)發佈了關於用於治療導致肝腫脹的丙型肝炎病毒感染的bemnifosbuvir和ruz實現的第二階段研究數據,這種感染可能導致嚴重的肝損傷。
The study met its primary endpoints of safety and sustained virologic response at 12 weeks post-treatment (SVR12).
該研究達到了其主要目標,即在治療後12周的安全性和持續的病毒學反應(SVR12)。
Primary endpoint results demonstrated a 98% (208/213) SVR12 rate in the per-protocol treatment adherent patient population after eight weeks of treatment with a regimen of bemnifosbuvir and ruzasvir.
主要終點結果表明,在接受bemnifosbuvir和ruz實現的八週治療後,符合治療方案的患者群體中SVR12率爲98%(208/213)。
Also Read: Atea Pharmaceuticals' COVID-19 Treatment Flunks In Late-Stage Study, Blames' Constantly Evolving' Virus
另請閱讀:atea pharmaceuticals的COVID-19治療在後期研究中失敗,歸咎於'不斷演變'的病毒。
The efficacy evaluable patient population, which included 17% treatment non-adherent patients, achieved a 95% (242/256) SVR12 rate demonstrating the potency and forgiveness of the regimen.
包括17%不遵守治療的患者在內的有效性可評估患者群體,達到95%(242/256)的SVR12率,展示了該方案的強效和寬容性。
In June, Atea Pharmaceuticals shared new data from the lead-in cohort (n=60) of its ongoing Phase 2 combination study of bemnifosbuvir and ruzasvir for hepatitis C virus.
在六月,atea pharmaceuticals分享了其正在進行的第二階段聯合研究(n=60)中關於bemnifosbuvir和ruz實現的帶入隊列的新數據,用於治療丙型肝炎病毒。
The regimen was generally safe and well-tolerated, with no drug-related serious adverse events or treatment discontinuations.
該方案通常安全且耐受良好,沒有藥物相關的嚴重不良事件或治療中斷。
Full data for the Phase 2 study will be presented at a scientific meeting during the first half of 2025.
關於第二階段研究的完整數據將在2025年上半年的一次科學會議上發佈。
In the Phase 2 study, 99% (178/179) of treatment-adherent patients who were non-cirrhotic and infected with genotypes 1-4 achieved SVR12, demonstrating robust pan-genotypic potency and supporting an eight-week treatment in the Phase 3 program.
在第二階段研究中,99%(178/179)符合治療要求的無肝硬化且感染基因型1-4的患者實現了SVR12,展示了強大的泛基因型效力,並支持在第三階段項目中進行八週的治療。
Treatment adherent patients with cirrhosis achieved a 88% (30/34) SVR12 rate.
有肝硬化的符合治療要求的患者實現了88%(30/34)的SVR12率。
Viral kinetics were slower in these cirrhotic patients. However, all patients achieved 100% end-of-treatment response. To maximize efficacy, the Phase 3 program will extend treatment duration to 12 weeks in patients with cirrhosis.
這些肝硬化患者的病毒動力學較慢。然而,所有患者都實現了100%的治療結束反應。爲了最大化療效,第三階段項目將把肝硬化患者的治療持續時間延長至12周。
Atea is preparing for the Phase 3 program, which is expected to follow an End of Phase 2 meeting with the FDA anticipated for early 2025.
atea pharmaceuticals正在爲第三階段項目做準備,預計將在2025年初與FDA的第二階段結束會議之後進行。
The Phase 3 program is expected to use a fixed-dose combination tablet, reducing the daily pill count from four to two tablets and enhancing patient convenience, with no food effect.
第三階段項目預計將使用固定劑量組合片劑,將每日藥片數量從四片減少到兩片,提高患者的便利性,並且不受食物影響。
Price Action: AVIR stock is down 9.63% at $3.15 at the last check on Wednesday.
價格動態:AVIR股票在週三最後一次檢查時下跌了9.63%,報$3.15。
- Southland Holdings Lands $60M Wastewater Deal: Details
- Southland Holdings獲得6000萬的廢水交易:詳細信息
譯文內容由第三人軟體翻譯。