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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分享療法研究對丙型肝炎病毒的有望數據。
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(納斯達克股票代碼:AVIR)週三公佈了該公司正在進行的本尼氟布韋治療丙型肝炎病毒(HCV)的2期聯合研究的主導隊列(n=60)的新數據。

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名患者的治療持續時間爲八週,來自非肝硬化患者隊列的2期數據顯示,治療後12周(SVR12)的持續病毒學反應率爲97%,這是該研究的主要療效終點。

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.

該公司還將提供臨床前數據,進一步證明本尼氟布韋具有很高的耐藥性和藥代動力學屏障,魯扎斯韋的藥物相互作用風險較低。

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.

該組合總體上是安全的,耐受性良好。沒有與藥物相關的嚴重不良事件或停止治療,不良事件大多是輕微的。

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

這些數據將在歐洲肝臟研究協會(EASL)大會上公佈。

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.

第二階段研究的先導隊列的結果還顯示,感染基因型 3(n=13)的參與者中,SVR12 發病率爲 100%,這是一種歷史上難以治療的丙型肝炎基因型。

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

該組合方案的耐受性良好,沒有與藥物相關的嚴重不良事件(SAE)或停止治療。

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

該公司表示,第二階段研究繼續招收多達220名受試者,包括代償性肝硬化的受試者。

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.

該公司表示,結果還表明,在所有測試的基因型中,本尼氟布韋的效力至少是治療丙型肝炎的藥物索非布韋的十倍,並且對已發現會改變索非布韋活性的耐藥相關替代物(RASs)沒有耐藥性。

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.

在大鼠體內單劑量口服後,本尼氟布韋具有良好的整體吸收、分佈、代謝和排泄(ADME)特性,包括良好的生物利用度(> 60%)和廣泛分佈於腦部滲透率低的組織。

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

價格走勢:週三最後一次檢查時,AVIR股價上漲2.12%,至3.85美元。

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