Enanta Pharmaceuticals to Present Topline Results From First-in-Pediatrics Phase 2 Study Evaluating Zelicapavir for Respiratory Syncytial Virus (RSV)
Enanta Pharmaceuticals to Present Topline Results From First-in-Pediatrics Phase 2 Study Evaluating Zelicapavir for Respiratory Syncytial Virus (RSV)
- Conference call and webcast to discuss data on Monday, December 9 at 8:30 a.m. ET
- 電話會議和網絡廣播將於12月9日星期一上午8:30(東部時間)討論數據
WATERTOWN, Mass.--(BUSINESS WIRE)--Dec. 6, 2024--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for virology and immunology indications, today announced the company will hold a conference call and webcast on Monday, December 9 at 8:30 a.m. ET to share topline results from RSVPEDs, a first-in-pediatrics Phase 2 study evaluating zelicapavir in hospitalized and non-hospitalized children aged 28 days to 36 months with respiratory syncytial virus (RSV).
馬薩諸塞州沃特敦--(BUSINESS WIRE)--2024年12月6日--專注於爲病毒學和免疫學適應症開發小分子藥物的生物技術臨床階段公司Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) 今日宣佈該公司將於12月9日週一上午8:30在東部時間舉行一個電話會議和網絡直播,分享RSVPEDs項目中來自首個兒科第2期研究的擇利卡帕韋在28天至36個月的住院和非住院兒童中呼吸道合胞病毒(RSV)的頭條結果。
Conference Call and Webcast Information
The live webcast on Monday, December 9 at 8:30 a.m. ET can be accessed at "Events & Presentations" in the investors section of Enanta's website. To participate by phone, please register for the call here. It is recommended that participants register a minimum of 15 minutes before the call. Once registered, participants will receive an email with the dial-in information. The archived webcast will be available on Enanta's website for approximately 30 days following the event.
電話會議和網絡直播信息
12月9日週一上午8:30的現場網絡直播可在Enanta網站投資者部門的"活動與演示"中進行訪問。要通過電話參與,請在此處註冊通話。建議參與者在通話前至少提前15分鐘註冊。註冊後,參與者將收到包含撥入信息的電子郵件。存檔的網絡直播將在活動結束後Enanta網站上約30天可供查看。
About Zelicapavir
Zelicapavir, Enanta's lead N-protein inhibitor, is being developed for the treatment of RSV infection, and has been granted Fast Track designation by the U.S. Food and Drug Administration. Zelicapavir is a nanomolar inhibitor of both RSV-A and RSV-B activity. Zelicapavir is differentiated from RSV fusion inhibitors as the N-protein inhibitor targets the virus' replication machinery and has demonstrated a high barrier to resistance in vitro. In preclinical studies, zelicapavir maintained antiviral potency across all clinical isolates tested and was active against viral variants resistant to other mechanisms. Zelicapavir demonstrated a favorable safety, pharmacokinetic and drug-drug interaction profile in an extensive Phase 1 program. In a Phase 2 challenge study, zelicapavir achieved highly statistically significant (p<0.001) reductions in RSV viral load and clinical symptoms compared to placebo and was safe and well-tolerated, with infrequent adverse events. Zelicapavir is currently being evaluated in RSVHR, a Phase 2b study in the elderly and/or those with congestive heart failure, chronic obstructive pulmonary disease (COPD) or asthma.
關於擇利卡帕韋
Enanta的首席N蛋白抑制劑擇利卡帕韋正在爲RSV感染的治療開發,並已獲得美國食品和藥物管理局的快速通道指定。擇利卡帕韋是RSV-A和RSV-B活性的納摩爾抑制劑。擇利卡帕韋與RSV融合抑制劑有所不同,因爲N蛋白抑制劑靶向病毒的複製機器,並在 vitro中表現出對抗逆轉的高障礙。在臨床前研究中,擇利卡帕韋在所有臨床分離物中保持抗病毒效力,並對耐其他機制的病毒變異體活性。擇利卡帕韋在廣泛的第1期計劃中表現出有利的安全、藥代動力學和藥物相互作用特性。在第2期挑戰研究中,與安慰劑相比,擇利卡帕韋實現了針對RSV病毒載量和臨床症狀的高度統計學顯著(p
About Respiratory Syncytial Virus
RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under one year of age in the United States and a significant cause of respiratory illness in older adults and immunocompromised individuals.1 According to the Centers for Disease Control and Prevention, virtually all children in the United States get an RSV infection by the time they are two years old and one to two out of every 100 children younger than six months of age with an RSV infection may need to be hospitalized.2 Globally, there are an estimated 33 million cases of RSV annually in children less than five years of age, with about 3 million hospitalized and up to approximately 100,000 dying each year from complications associated with the infection.3 RSV represents a significant health threat for adults older than 65 years of age, with an estimated 177,000 hospitalizations and 14,000 deaths associated with RSV infections annually in the United States.4
關於呼吸道合胞病毒
RSV是美國兒童1歲以下最常見的支氣管炎(肺部小氣道炎症)和肺炎的主要原因,在美國也是老年人和免疫功能受損個體呼吸系統疾病的重要原因。根據疾病控制和預防中心的數據,美國幾乎所有的兒童在兩歲之前都會感染RSV,而每100名六個月以下感染RSV的兒童中可能有一到兩名需要住院治療。全球每年有大約3300萬例5歲以下兒童感染RSV,約有300萬人需要住院治療,約有大約10萬人因感染併發症而死亡。對於65歲以上的成年人來說,RSV是一種重要的健康威脅,每年在美國約有177,000人因RSV感染住院治療,約有14,000人死於RSV感染。
About Enanta Pharmaceuticals, Inc.
Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs with an emphasis on indications in virology and immunology. Enanta's clinical programs are currently focused on respiratory syncytial virus (RSV) and its earlier-stage immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, including KIT and STAT6 inhibition.
關於Enanta製藥公司
enanta 正在利用其強大的以化學爲驅動的研究與藥物發現能力,成爲小分子藥物發現與開發的領導者,重點關注病毒學和免疫學的適應症。enanta 的臨床項目目前專注於呼吸道合胞病毒 (RSV),而其早期免疫學管線旨在通過靶向 2 型免疫反應的關鍵驅動因素,包括 KIt 和 STAT6 抑制,開發治療炎症疾病的方案。
Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic hepatitis c virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET (U.S.) and MAVIRET (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta's royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta's operations. Please visit for more information.
Glecaprevir是艾伯維公司發現的一種蛋白酶抑制劑,是治癒慢性丙型肝炎病毒(HCV)感染的主要治療方案之一,並由AbbVie在衆多國家以MAVYREt(美國)和MAVIREt(美國之外)(glecaprevir/pibrentasvir)的商標名銷售。Enanta與艾伯維公司合作開發的HCV產品中的一部分版稅爲Enanta的運營提供持續資金支持。請訪問 獲取更多信息。
Forward Looking Statements Disclaimer
This press release contains forward-looking statements, including with respect to the prospects for further development and advancement of zelicapavir for the treatment of RSV. Statements that are not historical facts are based on management's current expectations, estimates, forecasts and projections about Enanta's business and the industry in which it operates and management's beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: the development risks of early stage discovery efforts in the disease areas in Enanta's research and development pipeline, such as RSV; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for RSV; Enanta's limited clinical development experience; Enanta's need to attract and retain senior management and key scientific personnel; Enanta's need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in "Risk Factors" in Enanta's most recent Annual Report on Form 10-K for the fiscal year ended September 30, 2024 and other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. All forward-looking statements contained in this release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Enanta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
前瞻性聲明免責聲明
本新聞稿包含前瞻性聲明,涉及至澤立卡韋用於RSV治療的進一步發展和推進前景。非歷史事實的聲明基於管理層對艾南達業務及其所屬行業的當前期望、估計、預測和投射,以及管理層的信念和假設。本新聞稿中包含的聲明並非對未來業績的保證,並涉及某些難以預測的風險、不確定性和假設。因此,實際結果和成果可能與此類前瞻性聲明中所表達的有實質差異。可能影響實際結果的重要因素和風險包括:艾南達研發流水線中早期發現努力在疾病領域存在的研發風險,如RSV;他人在RSV競爭性治療方面的開發、監管和市場努力的影響;艾南達有限的臨床發展經驗;艾南達需要吸引和留住高級管理人員和關鍵科學人員;艾南達需要爲其產品候選藥物獲得並保持專利保護,避免侵犯他人的知識產權;以及其他在艾南達最近一份截至2024年9月30日財年結束的年度10-k表格以及更近期向美國證券交易委員會提交的定期報告中所描述或提及的風險因素。艾南達警告投資者不應對本新聞稿中包含的前瞻性聲明過分依賴。本新聞稿中包含的所有前瞻性聲明僅適用於其發佈之日,並基於管理層在此類日子作出的假設和估計。艾南達未承諾更新此類聲明以反映其發佈之日之後發生的事件或存在的情況,除非法律要求。
- Centers for Disease Control & Prevention – Respiratory Syncytial Virus Last accessed: December 2024.
- Centers for Disease Control & Prevention – RSV in Infants and Young Children Last accessed: December 2024.
- Shi, Ting et al. "Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in young children in 2015: a systematic review and modelling study." Lancet (London, England) vol. 390,10098 (2017): 946-958. doi:10.1016/S0140-6736(17)30938-8
- Falsey, Ann R et al. "Respiratory syncytial virus infection in elderly and high-risk adults." The New England Journal of Medicine vol. 352,17 (2005): 1749-59. doi:10.1056/NEJMoa043951
- 疾病預防控制中心 - 呼吸道合胞病毒 上次訪問時間:2024年12月。
- 疾病預防控制中心 - 嬰兒和幼兒的RSV 上次訪問時間:2024年12月。
- Shi, Ting等人。"全球、區域和國家2015年因合胞病毒引起的嬰幼兒急性下呼吸道感染疾病負擔估計:一項系統回顧和建模研究。" 《柳葉刀》(倫敦,英國)第390卷,10098期(2017年):946-958。doi:10.1016/S0140-6736(17)30938-8
- Falsey, Ann R等人。"老年人和高風險成年人的呼吸道合胞病毒感染。" 《新英格蘭醫學雜誌》第352卷,17期(2005年):1749-59。doi:10.1056/NEJMoa043951
View source version on businesswire.com:
在businesswire.com上查看源版本:
Media and Investors Contact:
Jennifer Viera
617-744-3848
jviera@enanta.com
媒體和投資者聯繫:
詹妮弗·維埃拉
617-744-3848
jviera@enanta.com
Source: Enanta Pharmaceuticals, Inc.
來源:enanta pharmaceuticals公司。
譯文內容由第三人軟體翻譯。