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Atea Pharmaceuticals Shares Promising Data From Therapy Study For Hepatitis C Virus

Atea Pharmaceuticals Shares Promising Data From Therapy Study For Hepatitis C Virus

atea pharmaceuticals发布治疗丙型肝炎病毒的有前途的数据
Benzinga ·  06/05 10:55

Atea Pharmaceuticals Inc (NASDAQ:AVIR) announced Wednesday new data from the lead-in cohort (n=60) of the company's ongoing Phase 2 combination study of bemnifosbuvir for hepatitis C virus (HCV).

Atea Pharmaceuticals Inc(纳斯达克股票代码:AVIR)周三公布了该公司正在进行的本尼氟布韦治疗丙型肝炎病毒(HCV)的2期联合研究的主导队列(n=60)的新数据。

With an eight-week treatment duration in 60 patients, the Phase 2 data from the lead-in cohort of non-cirrhotic patients showed a 97% sustained virologic response rate at 12 weeks post-treatment (SVR12), the study's primary efficacy endpoint.

60名患者的治疗持续时间为八周,来自非肝硬化患者队列的2期数据显示,治疗后12周(SVR12)的持续病毒学反应率为97%,这是该研究的主要疗效终点。

The company will also present preclinical data further demonstrating a high barrier to resistance and pharmacokinetics for bemnifosbuvir and a low risk of drug-drug interactions for ruzasvir.

该公司还将提供临床前数据,进一步证明本尼氟布韦具有很高的耐药性和药代动力学屏障,鲁扎斯韦的药物相互作用风险较低。

The combination was generally safe and well tolerated. There were no drug-related serious adverse events or treatment discontinuations, and adverse events were mostly mild.

该组合总体上是安全的,耐受性良好。没有与药物相关的严重不良事件或停止治疗,不良事件大多是轻微的。

These data will be presented at the European Association for the Study of the Liver (EASL) Congress.

这些数据将在欧洲肝脏研究协会(EASL)大会上公布。

Results from the lead-in cohort of the Phase 2 study also showed a 100% SVR12 rate in participants infected with genotype 3 (n=13), a historically difficult-to-treat genotype of HCV.

第二阶段研究的先导队列的结果还显示,感染基因型 3(n=13)的参与者中,SVR12 发病率为 100%,这是一种历史上难以治疗的丙型肝炎基因型。

The combination regimen was well tolerated, with no drug-related severe adverse events (SAEs) or treatment discontinuations.

该组合方案的耐受性良好,没有与药物相关的严重不良事件(SAE)或停止治疗。

The company says the Phase 2 study continues to enroll up to an additional 220 subjects, including those with compensated cirrhosis.

该公司表示,第二阶段研究继续招收多达220名受试者,包括代偿性肝硬化的受试者。

The company said that the results also demonstrated that bemnifosbuvir is at least ten-fold more potent than sofosbuvir, a medication to treat HCV infections, across all genotypes tested and is not resistant to resistance-associated substitutions (RASs) that have been found to alter the activity of sofosbuvir.

该公司表示,结果还表明,在所有测试的基因型中,本尼氟布韦的效力至少是治疗丙型肝炎的药物索非布韦的十倍,并且对已发现会改变索非布韦活性的耐药相关替代物(RASs)没有耐药性。

Following a single oral dose in rats, bemnifosbuvir has favorable overall absorption, distribution, metabolism, and excretion (ADME) properties, including good bioavailability (>60%) and wide distribution to tissues with low penetration into the brain.

在大鼠体内单剂量口服后,本尼氟布韦具有良好的整体吸收、分布、代谢和排泄(ADME)特性,包括良好的生物利用度(> 60%)和广泛分布于脑部渗透率低的组织。

Price Action: AVIR shares are up 2.12% at $3.85 at last check Wednesday.

价格走势:周三最后一次检查时,AVIR股价上涨2.12%,至3.85美元。

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