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Atea Pharmaceuticals' COVID-19 Treatment Flunks In Late-Stage Study, Blames 'Constantly Evolving' Virus

Atea Pharmaceuticals' COVID-19 Treatment Flunks In Late-Stage Study, Blames 'Constantly Evolving' Virus

atea pharmaceuticals的COVID-19治療在後期研究中失敗,將責任歸咎於「不斷演變」的病毒
Benzinga ·  09/13 14:53

On Friday, Atea Pharmaceuticals Inc. (NASDAQ:AVIR) announced the outcome of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, versus placebo for COVID-19.

週五,Atea Pharmicals Inc.(納斯達克股票代碼:AVIR)公佈了全球 3 期 SUNRISE-3 試驗的結果,該試驗評估了口服核苷酸聚合酶抑制劑本尼磷布韋對比 COVID-19 的安慰劑。

The trial did not meet the primary endpoint of a statistically significant reduction in all-cause hospitalization or death through Day 29 in the monotherapy cohort of 2,221 high-risk patients with mild to moderate COVID-19.

在由2,221名輕度至中度 COVID-19 高風險患者組成的單一療法隊列中,截至第 29 天,該試驗尚未達到全因住院或死亡人數在統計學上顯著減少的主要終點。

In SUNRISE-3, bemnifosbuvir was generally safe and well tolerated.

在 SUNRISE-3 中,本尼氟布韋總體上是安全的,耐受性良好。

"We are disappointed by the outcome of the SUNRISE-3 trial. Variants of COVID-19 are constantly evolving and the natural history of the disease trended toward milder disease, which has resulted in fewer hospitalizations and deaths," said Jean-Pierre Sommadossi, CEO and Founder of Atea Pharmaceuticals.

“我們對 SUNRISE-3 試驗的結果感到失望。Atea Pharmaceuticals首席執行官兼創始人讓-皮埃爾·索馬多西說,COVID-19 的變種在不斷演變,該疾病的自然史趨於輕微的疾病,從而減少了住院和死亡人數。

"In particular, hospitalization due to severe respiratory disease caused by COVID was not observed in SUNRISE-3, in contrast to our prior study. In an environment where there is much less COVID-19 pneumonia, it becomes more difficult for a direct-acting antiviral to demonstrate impact on the course of the disease," Sommadossi added.

「特別是,與我們之前的研究相比,在 SUNRISE-3 中沒有觀察到由COVID引起的嚴重呼吸道疾病導致的住院。在 COVID-19 肺炎發病率要少得多的環境中,直接作用的抗病毒藥物更難表現出對疾病病程的影響,」 索馬多西補充說。

Atea remains focused on developing the combination of bemnifosbuvir and ruzasvir for hepatitis C.

Atea仍然專注於開發治療丙型肝炎的本尼磷布韋和魯扎斯韋的組合物。

In June, Atea Pharmaceuticals released new data from the lead-in cohort (n=60) of the company's ongoing Phase 2 combination study of bemnifosbuvir for hepatitis C.

6月,Atea Pharmaceuticals發佈了該公司正在進行的本尼氟布韋治療丙型肝炎的2期聯合研究的主導隊列(n=60)的新數據

The company plans to announce additional results from the Phase 2 trial in the fourth quarter of 2024.

該公司計劃在2024年第四季度公佈第二階段試驗的更多結果。

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, 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周的持續病毒學反應率爲97%,這是該研究的主要療效終點。

Price Action: AVIR stock is up 3.41% to $3.80 at the last check on Friday.

價格走勢:在週五的最後一次支票中,AVIR股價上漲3.41%,至3.80美元。

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