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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治疗在后期研究中失败,将责任归咎于“不断演变”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.

上周五,atea pharmaceuticals inc.(纳斯达克:avir)宣布了全球第三阶段sunrise-3试验的结果,该试验评估了一种口服核苷酸聚合酶抑制剂bemnifosbuvir与安慰剂在新冠肺炎方面的疗效。

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2,221名轻至中度新冠肺炎的高风险患者的单药疗法队列中,该试验未达到主要终点——在29天内统计学上显著减少全因住院或死亡的结果。

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

在sunrise-3试验中,bemnifosbuvir的安全性和耐受性良好。

"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.

atea pharmaceuticals的ceo兼创始人让-皮埃尔·索马多西表示:“我们对sunrise-3试验的结果感到失望。新冠肺炎的变异持续不断演变,疾病的自然进程趋向于较轻型,这导致住院和死亡的情况减少。”

"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.

索马多西补充道:“特别是由新冠肺炎引起的严重呼吸系统疾病住院率在sunrise-3试验中没有观察到,这与我们之前的研究相反。在新冠肺炎肺炎减少的环境中,直接抗病毒药物更难以证明对病情进程的影响。”

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

atea pharmaceuticals仍致力于开发bemnifosbuvir和ruzasvir的联合用于治疗丙型肝炎。

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.

今年6月,atea pharmaceuticals发布了该公司进行中的丙型肝炎二期联合研究的引导队列(n=60)的新数据。

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

该公司计划在2024年第四季度宣布丙型肝炎二期试验的其他结果。

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.

在一个由非肝硬化患者组成的前继群体中进行的60例患者的8周治疗期间,2期研究数据显示,治疗后12周的持续病毒学应答率为97%,这是该研究的主要疗效终点。

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

股价表现:周五最后一次检查时,AVIR股票上涨3.41%至3.80美元。

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