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.
在周三,atea pharmaceuticals(纳斯达克:AVIR)发布了治疗肝炎C病毒感染的bemnifosbuvir和ruzazvir方案的第二阶段研究数据,该感染会导致肝脏肿胀并可能导致严重的肝损伤。
The study met its primary endpoints of safety and sustained virologic response at 12 weeks post-treatment (SVR12).
该研究达到了其主要的安全性和治疗后12周的持续病毒学应答(SVR12)目标。
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.
主要终点结果显示,在遵循治疗方案的患者群体中,经过八周的bemnifosbuvir和ruzazvir治疗后,SVR12率为98%(208/213)。
Also Read: Atea Pharmaceuticals' COVID-19 Treatment Flunks In Late-Stage Study, Blames' Constantly Evolving' Virus
另请阅读:atea pharmaceuticals的COVID-19治疗在晚期研究中失利,指责“不断演变”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.
包含17%治疗不依从患者的有效性可评估患者群体,实现了95%(242/256)的SVR12率,证明了该方案的有效性和宽容性。
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6月,atea pharmaceuticals分享了其正在进行的第二阶段组合研究(n=60)中关于bemnifosbuvir和ruzazvir治疗肝炎C病毒的新数据。
The regimen was generally safe and well-tolerated, with no drug-related serious adverse events or treatment discontinuations.
该方案总体上是安全的并且耐受性良好,没有与药物相关的严重不良事件或治疗中断。
Full data for the Phase 2 study will be presented at a scientific meeting during the first half of 2025.
第二阶段研究的完整数据将在2025年上半年的一次科学会议上发表。
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.
在第二阶段研究中,99%(178/179)的治疗依从性患者(非肝硬化且感染1-4型基因型)达到了SVR12,显示出强大的泛基因型效力,并支持在第三阶段项目中进行八周的治疗。
Treatment adherent patients with cirrhosis achieved a 88% (30/34) SVR12 rate.
患有肝硬化的治疗依从性患者达到了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.
这些肝硬化患者的病毒动力学更慢。然而,所有患者在治疗结束时都达到了100%的反应率。为了最大化疗效,第三阶段项目将在肝硬化患者中将治疗持续时间延长至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正在为第三阶段项目做准备,该项目预计将在2025年初与FDA举行的第二阶段结束会议之后进行。
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.
第三阶段项目预计将使用固定剂量联合片剂,将每日药片数量从四片减少到两片,提高患者的便利性,并且没有食物影响。
Price Action: AVIR stock is down 9.63% at $3.15 at the last check on Wednesday.
价格动态:AVIR股票在周三最后检查时下跌9.63%,报$3.15。
- Southland Holdings Lands $60M Wastewater Deal: Details
- Southland Holdings获得6000万美元的废水交易:详情