Presentations to Include New Antiviral Efficacy Results, Including SVR12 Data, from Lead-In Cohort of Ongoing Phase 2 HCV Trial

演示文稿包括正在进行的2期HCV试验队列中的新抗病毒疗效结果，包括SVR12数据

Data Also Highlight the High Prevalence of Pre-Existing NS5A Resistance-Associated Substitutions (RAS) Detected in HCV-infected Patients

数据还突出了在HCV感染患者中检测到的预先存在的NS5A耐药相关替代（RAS）的高患病率

BOSTON, May 22, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced the Company will present new efficacy results, including SVR12 data (primary endpoint), from the Phase 2 lead-in cohort evaluating the combination of bemnifosbuvir (an oral nucleotide NS5B polymerase inhibitor) and ruzasvir (an oral NS5A inhibitor) for the treatment of hepatitis C virus (HCV) at the European Association for the Study of the Liver (EASL) Congress 2024, taking place June 5-8, 2024 in Milan, Italy.

波士顿，2024年5月22日（环球通讯社）--Atea制药公司（纳斯达克股票代码：AVIR）（“Atea”）是一家临床阶段的生物制药公司，致力于发现和开发针对严重病毒性疾病的口服抗病毒治疗剂，今天宣布该公司将在2024年6月5日至8日举行的欧洲肝脏研究协会（EASL）2024年大会上提交新的疗效结果，包括SVR12数据（主要终点），该数据来自第二阶段导入队列，该队列评估了bemnifosbuvir（一种口服核苷酸NS5B聚合酶抑制剂）和ruzasvir（一种口服NS5A抑制剂）治疗丙型肝炎病毒（HCV）的组合4在意大利米兰。

Preclinical data further demonstrating bemnifosbuvir’s high barrier to resistance and pharmacokinetics and ruzasvir’s low risk of drug-drug interactions will also be presented..

还将提供临床前数据，进一步证明贝米诺布韦对耐药性和药代动力学的高屏障以及鲁扎斯韦对药物相互作用的低风险。。

“Despite current HCV treatments, progress toward eliminating the virus in the U.S. has slowed, and new chronic cases exceed cure rates. In the decade since the first direct acting antiviral treatments were introduced, both the virus and the patient population have changed significantly, including the emergence of resistant mutations,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals.

Atea Pharmaceuticals首席执行官兼创始人Jean-Pierre Sommadossi博士说：“尽管目前正在进行丙型肝炎病毒治疗，但美国消除丙型肝炎病毒的进展已经放缓，新的慢性病例超过了治愈率。自推出第一种直接作用的抗病毒治疗以来的十年中，病毒和患者群体都发生了重大变化，包括耐药突变的出现。”。

“We need new HCV treatments that address the needs of today’s patients and feature a best-in-class treatment profile with high antiviral potency, short treatment duration, potential for low risk of drug-drug interactions and a high barrier to resistance. We look forward to sharing our data at EASL Congress 2024, which will reinforce the potential of this combination to treat HCV as it exists today.”.

“我们需要新的HCV治疗方法，以满足当今患者的需求，并具有一流的治疗效果，具有高抗病毒效力，治疗时间短，药物相互作用风险低和耐药性高的潜力。我们期待在2024年EASL大会上分享我们的数据，这将增强这种组合治疗HCV的潜力。”。

More than 2 million people in the U.S. are living with chronic HCV, and approximately 100,000 new chronic cases are diagnosed each year. HCV diagnoses continually outpace annual cure rates, as less than a third of those diagnosed with HCV receive timely treatment. As HCV persists, six main variants, or genotypes, have emerged.

美国有200多万人患有慢性HCV，每年诊断出约10万例新的慢性病例。HCV诊断持续超过年治愈率，因为被诊断患有HCV的人中只有不到三分之一得到及时治疗。随着HCV的持续存在，出现了六种主要变体或基因型。

Genotype 1 is the most prevalent, while some variants, such as genotype 3, can be more difficult to treat due to mutations that enable the virus to develop resistance against existing HCV drugs..

基因型1是最普遍的，而一些变异，如基因型3，由于突变使病毒对现有HCV药物产生耐药性，可能更难治疗。。

The full datasets for the accepted abstracts will become available on the EASL Congress website following the embargo lift on Wednesday, June 5th at 8:00 AM Central European Time (CEST).

在6月5日（星期三）中欧时间（CEST）上午8:00解除禁运后，EASL大会网站将提供已接受摘要的完整数据集。

Details for the EASL Congress presentations are as follows:

EASL大会演示的详细信息如下：

Poster ID: THU-382

海报编号：THU-382

Title: Lead-in Cohort Results From a Phase 2 Study of a Novel 8-Week Combination Regimen of Bemnifosbuvir and Ruzasvir in Patients with Chronic Hepatitis C Virus Infection

标题：对慢性丙型肝炎病毒感染患者进行的一项为期8周的新型贝尼非布韦和鲁扎斯韦联合治疗方案的2期研究的队列研究结果

Presenting Author: Alina Jucov, M.D., Ph.D.

介绍作者：医学博士Alina Jucov。

Date and Time: June 6, 2024, 8:30 AM CEST

日期和时间：2024年6月6日，美国东部时间上午8:30

Poster ID: SAT-402

海报编号：SAT-402

Title: Bemnifosbuvir is a Potent HCV NS5B Inhibitor with a Favorable Antiviral Profile and High Resistance Barrier

标题：Bemnifosbuvir是一种有效的HCV NS5B抑制剂，具有良好的抗病毒特性和高抗性屏障

Presenting Author: Qi Huang, Ph.D.

报告作者：Qi Huang博士。

Date and Time: June 8, 2024, 8:30 AM CEST

日期和时间：2024年6月8日，美国东部时间上午8:30

Poster ID: SAT-411

海报编号：SAT-411

Title: Absorption, Distribution, Metabolism, and Excretion of [14C]-Bemnifosbuvir in Rats

标题：[14C]-Bemnifosbuvir在大鼠体内的吸收、分布、代谢和排泄

Presenting Author: Alex Vo, Ph.D.

演示作者：Alex Vo，博士。

Date and Time: June 8, 2024, 8:30 AM CEST

日期和时间：2024年6月8日，美国东部时间上午8:30

Poster ID: SAT-412

海报编号：SAT-412

Title: Low Risk of Drug-Drug Interactions for Ruzasvir Based Upon In Vitro Metabolism and Transporter Interaction Studies

标题：基于体外代谢和转运蛋白相互作用研究，Ruzasvir的药物相互作用风险低

Presenting Author: Alex Vo, Ph.D.

演示作者：Alex Vo，博士。

Date and Time: June 8, 2024, 8:30 AM CEST

日期和时间：2024年6月8日，美国东部时间上午8:30

About Bemnifosbuvir and Ruzasvir for Hepatitis C Virus (HCV)

关于贝尼福布韦和鲁扎斯韦治疗丙型肝炎病毒（HCV）

Bemnifosbuvir is an oral, purine nucleotide prodrug designed to inhibit viral replication by impairing viral RNA polymerase, a key component in the replication machinery of enveloped positive single-stranded RNA viruses, such as human coronaviruses and HCV. Atea is developing bemnifosbuvir in combination with ruzasvir, an oral NS5A inhibitor for the treatment of HCV.

Bemnifosbuvir是一种口服嘌呤核苷酸前药，旨在通过损害病毒RNA聚合酶来抑制病毒复制，病毒RNA聚合酶是包膜阳性单链RNA病毒（如人冠状病毒和HCV）复制机制的关键组成部分。Atea正在开发bemnifosbuvir联合ruzasvir，一种用于治疗HCV的口服NS5A抑制剂。

As single agents, both bemnifosbuvir and ruzasvir have demonstrated potent pan-genotypic antiviral activity against HCV. The combination of bemnifosbuvir and ruzasvir has exhibited synergistic in vitro activity against HCV with no pharmacokinetic (PK) drug-drug interactions in healthy volunteers..

作为单一药物，bemnifosbuvir和ruzasvir均显示出针对HCV的有效泛基因型抗病毒活性。bemnifosbuvir和ruzasvir的组合对HCV具有协同的体外活性，在健康志愿者中没有药代动力学（PK）药物相互作用。。

In vitro studies have shown bemnifosbuvir to be approximately 10-fold more active than sofosbuvir (SOF) against a panel of laboratory strains and clinical isolates of HCV GT 1–5. In vitro studies have also demonstrated that bemnifosbuvir remained fully active against SOF resistance-associated strains (S282T), with up to 58-fold more potency than SOF.

体外研究表明，对于一组HCV GT 1-5的实验室菌株和临床分离株，贝尼福韦的活性比索非布韦（SOF）高约10倍。体外研究还表明，bemnifosbuvir对SOF抗性相关菌株（S282T）保持完全活性，效力比SOF高58倍。

The PK profile of bemnifosbuvir supports once-daily dosing for the treatment of HCV. Across both HCV and COVID-19 programs, bemnifosbuvir has been administered to over 2,100 subjects and has been well-tolerated at doses up to 550 mg for durations up 12 weeks in healthy subjects and patients..

bemnifosbuvir的PK谱支持每日一次给药治疗HCV。在HCV和新型冠状病毒肺炎（COVID-19）项目中，贝姆尼福布韦已被2100多名受试者服用，并且在健康受试者和患者中，在长达12周的时间内，剂量高达550 mg时耐受性良好。。

Ruzasvir has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. Ruzasvir has been administered to over 1,200 HCV-infected patients at daily doses of up to 180 mg for up to 12 weeks and has demonstrated a favorable safety profile. Ruzasvir’s PK profile supports once-daily dosing..

Ruzasvir在临床前（皮摩尔范围）和临床研究中表现出高效和泛基因型抗病毒活性。Ruzasvir已被用于1200多名HCV感染患者，每日剂量高达180 mg，持续12周，并显示出良好的安全性。Ruzasvir的PK配置文件支持每日一次给药。。

About the Phase 2 Study

关于第二阶段研究

Atea is currently conducting a global Phase 2 clinical trial of bemnifosbuvir in treatment-naïve, chronic HCV-infected patients either without cirrhosis or with compensated cirrhosis. This study is designed to evaluate the safety and efficacy of eight weeks of treatment with the combination consisting of once-daily bemnifosbuvir 550 mg and ruzasvir 180 mg.

Atea目前正在对未经治疗的慢性HCV感染患者（无肝硬化或代偿性肝硬化患者）进行贝米非布韦的全球2期临床试验。这项研究旨在评估八周治疗的安全性和有效性，该联合治疗包括每日一次的bemnifosbuvir 550 mg和ruzasvir 180 mg。

Up to approximately 280 chronically infected, treatment-naïve patients across all HCV genotypes, including the lead-in cohort of 60 patients without cirrhosis, are expected to be enrolled in this Phase 2 clinical trial..

预计将有多达280名所有HCV基因型的慢性感染，未接受治疗的患者（包括60名无肝硬化患者的引入队列）参加这项2期临床试验。。

The primary endpoints of the study are safety and sustained virologic response (SVR) at Week 12 post-treatment (SVR12). Other virologic endpoints include virologic failure, SVR at Week 24 post-treatment (SVR24) and resistance. Results from the 60-patient lead-in cohort announced in February 2024 demonstrated a 98% SVR4 rate across genotypes from 58 of 59 patients, which include a patient with poor adherence who did not achieve SVR4 and exclude one patient who did not attend the Week 4 post-treatment follow-up.

该研究的主要终点是治疗后第12周（SVR12）的安全性和持续病毒学应答（SVR）。其他病毒学终点包括病毒学失败，治疗后第24周的SVR（SVR24）和耐药性。2024年2月宣布的60名患者引入队列的结果显示，59名患者中有58名患者的基因型SVR4率为98%，其中包括一名依从性差的患者，未达到SVR4，排除了一名未参加第4周治疗后随访的患者。

Topline results from all patients enrolled in the Phase 2 study are anticipated in the second half of 2024..

预计2024年下半年，所有参加第二阶段研究的患者的最终结果。。

About Atea Pharmaceuticals

关于Atea Pharmaceuticals

Atea is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging the Company’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of serious viral diseases.

Atea是一家临床阶段的生物制药公司，专注于发现，开发和商业化口服抗病毒疗法，以解决严重病毒感染患者未满足的医疗需求。利用公司对抗病毒药物开发，核苷（t）ide化学，生物学，生物化学和病毒学的深入了解，Atea建立了专有的核苷（t）ide前药平台，以开发新的候选产品来治疗单链核糖核酸或ssRNA病毒，这是严重病毒性疾病的普遍原因。

Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Currently, Atea is focused on the development of orally-available antiviral agents for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, and hepatitis C virus (HCV).

Atea计划通过将其nucleos（t）ide平台与其他类别的抗病毒药物（可与nucleos（t）ide候选产品组合使用）进行扩展，继续构建其抗病毒候选产品管道。目前，Atea专注于开发用于严重急性呼吸综合征冠状病毒2（SARS-CoV-2），引起COVID-19的病毒和丙型肝炎病毒（HCV）的口服抗病毒药物。

For more information, please visit www.ateapharma.com..

欲了解更多信息，请访问www.ateapharma.com。。

Forward-Looking Statements

前瞻性声明

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to the Company’s plans relating to the date and time of the presentations at the conference and the potential of bemnifosbuvir in combination with ruzasvir to treat HCV if successfully developed.

本新闻稿包括1995年《私人证券诉讼改革法案》所指的“前瞻性声明”。本新闻稿中的前瞻性声明包括但不限于公司计划在会议上介绍的日期和时间，以及如果成功开发，贝尼福韦联合鲁扎斯韦治疗HCV的潜力。

trial results. When used herein, words including “expects,” “may,” “will,” “anticipates,” “plans,” and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking.

试验结果。当在本文中使用时，包括“预期”、“可能”、“将”、“预期”、“计划”和类似表达在内的词语旨在识别前瞻性陈述。此外，任何涉及未来事件或情况的期望、信念、计划、预测、目标、绩效或其他特征的陈述或信息，包括任何基本假设，都是前瞻性的。

All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct.

所有前瞻性陈述均基于公司当前的预期和各种假设。该公司认为其期望和信念有一个合理的基础，但它们本质上是不确定的。公司可能无法实现其期望，其信念也可能不正确。

Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, the important factors discussed and updated from time to time under the caption “Risk Factors” in the reports the Company files with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and other filings each of which are accessible on the SEC’s website at www.sec.gov.

由于各种重要因素的影响，实际结果可能与此类前瞻性声明所描述或暗示的结果存在重大差异，包括但不限于公司向美国证券交易委员会提交的报告中“风险因素”标题下不时讨论和更新的重要因素，包括表10-K中的年度报告、表10-Q中的季度报告、表8-K中的当前报告以及可在美国证券交易委员会网站www.SEC.gov上查阅的其他文件。

These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press rele.

这些因素和其他重要因素可能导致实际结果与本新闻稿中的前瞻性声明所显示的结果存在重大差异。

Contacts

联系人

Jonae Barnes

乔纳·巴恩斯

SVP, Investor Relations and Corporate Communications

高级副总裁、投资者关系和企业传播

617-818-2985

617-818-2985

Barnes.jonae@ateapharma.com

Barnes.jonae@ateapharma.com

Will O’Connor

威尔·奥康纳

Stern Investor Relations

严格的投资者关系

212-362-1200

212-362-1200

will.oconnor@sternir.com

will.oconnor@sternir.com