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公司(納斯達克:AVIR)發佈了關於bemnifosbuvir和ruzasvir聯合用於導致肝臟腫脹並可能導致嚴重肝損傷的丙型肝炎病毒感染的2期研究數據。
The study met its primary endpoints of safety and sustained virologic response at 12 weeks post-treatment (SVR12).
該研究達到了治療後12周持續病毒學應答(SVR12)的安全性和主要終點。
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,在進行八週的bemnifosbuvir和ruzasvir治療後,符合方案的患者群體中SVR12率爲98%(208/213)。
Also Read: Atea Pharmaceuticals' COVID-19 Treatment Flunks In Late-Stage Study, Blames' Constantly Evolving' Virus
還閱讀:atea pharmaceuticals的COVID-19治療在晚期研究中失敗,責備「不斷進化」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%治療不遵從患者在內的有效性可評估患者總體實現了95%(242/256)的SVR12率,展示了該方案的效力和寬容度。
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分享了針對丙型肝炎病毒進行的bemnifosbuvir和ruzasvir聯合用於正在進行的2期組合研究的引導隊列(n=60)的新數據。
The regimen was generally safe and well-tolerated, with no drug-related serious adverse events or treatment discontinuations.
該療程通常安全且具有良好的耐受性,沒有藥物相關的嚴重不良事件或治療中止。
Full data for the Phase 2 study will be presented at a scientific meeting during the first half of 2025.
第2期研究的完整數據將在2025年上半年的一個科學會議上進行介紹。
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2階段研究中,99%(178/179)的遵從治療的非肝硬化患者(1-4基因型感染)實現了SVR12,顯示出強大的泛基因型效力,並支持第3階段計劃的8周治療。
Treatment adherent patients with cirrhosis achieved a 88% (30/34) SVR12 rate.
肝硬化患者中,88%(30/34)達到SVR12比率。
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,所有患者均實現了100%的治療結束後反應。爲了最大限度地提高療效,第3階段計劃將在肝硬化患者中將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 正在準備第3階段計劃,預計將在2025年初與FDA進行第2階段會議後啓動。
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3階段計劃預計將使用固定劑量的複合片劑,將每日藥片數量從4顆減少到2顆,增加患者的便利性,且無需考慮食物影響。
Price Action: AVIR stock is down 9.63% at $3.15 at the last check on Wednesday.
股價走勢:AVIR股價週三最後一次檢查時下跌9.63%,爲3.15美元。
- Southland Holdings Lands $60M Wastewater Deal: Details
- 南地控股以6000萬美元中標廢水處理協議:詳情