SAN FRANCISCO--(BUSINESS WIRE)--Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the Company has granted Norgine Pharma UK Limited, an affiliate of Norgine, a leading European specialty pharmaceutical company, an exclusive license for the commercial rights to the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta (CHD) in Europe, Australia and New Zealand. 1 Per the terms of the agreement, Vir Biotechnology will receive an initial reimbursement payment of EUR 55 m ...

Core Viewpoint - The latest data from the ENSURE Phase II study indicates significant potential for the BRII-179 therapeutic vaccine in achieving HBsAg clearance in patients with hepatitis B virus (HBV) infection, with sustained benefits observed over a 24-week follow-up period [1][2]. Group 1: Study Results - In the BRII-179 responder group, 58% (11 out of 19) achieved HBsAg clearance at the end of treatment (EOT), compared to only 17% (2 out of 12) in the non-responder group [2]. - After 24 weeks post-treatment, 42% (8 out of 19) of the BRII-179 responders maintained HBsAg clearance, while only 8% (1 out of 12) of non-responders did [2]. - Previous studies indicated that 50% (4 out of 8) of BRII-179 responders maintained HBsAg clearance 24 weeks after EOT, even with baseline HBsAg levels ranging from 1,514 to 3,086 IU/mL, suggesting the vaccine's efficacy in diverse patient populations [2]. Group 2: Ongoing Research - The company is conducting two additional Phase IIb studies: ENRICH, which evaluates BRII-179's role in inducing HBV-specific immunity, and ENHANCE, which assesses the effects of a combination therapy involving BRII-179, elebsiran, and PEG-IFNα [3]. - ENHANCE consists of two parts: one assessing the simultaneous administration of the three drugs for 48 weeks, and the other exploring a sequential approach with 24 weeks of BRII-179 and elebsiran followed by 24 weeks of combination therapy [3]. - Both studies have completed patient recruitment and are expected to report EOT data in 2026 [3].

Core Viewpoint - The company has announced promising results from the ENSURE II Phase study, indicating the potential of BRII-179 in achieving functional cure for hepatitis B virus (HBV) infection, with sustained benefits observed in HBsAg clearance among responders [1][2]. Group 1: Study Results - In the BRII-179 responder group, 58% (11 out of 19) achieved HBsAg clearance at the end of treatment (EOT), compared to only 17% (2 out of 12) in the non-responder group [2]. - After 24 weeks post-treatment, 42% (8 out of 19) of the responders maintained HBsAg clearance, while only 8% (1 out of 12) of non-responders did [2]. - Previous studies indicated that 50% (4 out of 8) of responders maintained HBsAg clearance 24 weeks after EOT, even with baseline HBsAg levels between 1,514-3,086 IU/mL, showcasing BRII-179's potential across different patient populations [2]. Group 2: Ongoing Research - The company is conducting two additional Phase IIb studies: ENRICH, which evaluates BRII-179's role in inducing HBV-specific immune responses, and ENHANCE, which assesses the effects of a combination therapy involving BRII-179, elebsiran, and PEG-IFNα [3]. - ENHANCE consists of two parts: one assessing the simultaneous administration of the three drugs for 48 weeks, and the other exploring a sequential approach with 24 weeks of BRII-179 and elebsiran followed by 24 weeks of combination therapy [3]. - Both studies have completed patient recruitment and are expected to report EOT data in 2026 [3].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不會就本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 ENSURE (NCT05970289)是一項在亞太地區開展的多中心、開放標籤II期研究。 隊列4評估了一種創新的乙型肝炎（「HBV」）序貫聯合治療策略，利用本公司的 治療性疫苗BRII-179進行患者免疫激活和富集，以提高其對潛在功能性治癒療 法的應答。該隊列納入了此前在BRII-179-835-001 II期研究(NCT04749368)中接 受過9劑elebsiran聯合BRII-179給藥的參與者，使其接受為期48周的elebsiran與 PEG-IFNα聯合治療。根據先前研究中乙肝表面抗體（「抗-HBs」）滴度峰值水平 （≥10 IU/L或<10 IU/L），參與者被定義為BRII-179抗-HBs應答者或無應答者。 隊列4的EOT數據此前已在2025年歐洲肝病研究協會(EASL)會議上公佈。最新 公佈的數據表明，在BRII-179應答者組中乙肝表面抗原（「HBsAg」）清除的獲 益效果在隨訪期 ...

Core Insights - Vir Biotechnology, Inc. announced positive results from the Week 48 endpoint analysis of its Phase 2 SOLSTICE trial for chronic hepatitis delta (CHD) [1] Group 1: Trial Results - Participants receiving a monthly dose of the combination of tobevibart and elebsiran achieved robust and sustained rates of hepatitis delta virus (HDV) RNA target not detected (TND) [1] - The combination treatment was effective even among participants with cirrhosis and high baseline HDV RNA levels [1]

Core Insights - The ENSURE II study results have been published in the peer-reviewed journal Nature Medicine, evaluating the efficacy and safety of the siRNA drug elebsiran in combination with PEG-IFNα for chronic hepatitis B treatment [1][2] - The study also explores the potential role of the therapeutic vaccine BRII-179 in enhancing immune response and HBsAg clearance rates in patients [1] Group 1: Study Design and Methodology - The ENSURE study was conducted in two parts: the first part involved participants who had not previously received BRII-179, randomly assigned to either 48 weeks of PEG-IFNα monotherapy or combination therapy with elebsiran [2] - The second part included participants from a prior study who had received elebsiran and BRII-179, categorized based on their anti-HBs peak levels, and subsequently treated with elebsiran and PEG-IFNα [2] Group 2: Research Implications - The lead researcher, Professor Jia Jidong, emphasized that the ENSURE study aims to provide scientific evidence for curative therapies for chronic hepatitis B and address key scientific questions [3] - Encouragingly, the 24-week follow-up data aligns with the results at the end of treatment, supporting the additional clinical benefits of elebsiran and indicating the potential new role of BRII-179 in activating the immune response in chronic hepatitis B patients [3]

Core Insights - The ENSURE II study results have been published in the peer-reviewed journal Nature Medicine, evaluating the efficacy and safety of the siRNA drug elebsiran in combination with PEG-IFNα for chronic hepatitis B treatment [1][2] - The study also explores the potential role of the therapeutic vaccine BRII-179 in enhancing immune response and increasing HBsAg clearance rates in patients [1] Group 1 - The ENSURE study was conducted in two parts, with the first part involving chronic HBV patients who had not previously received BRII-179, randomized to receive either 48 weeks of PEG-IFNα monotherapy or combination therapy with elebsiran [2] - In the second part, participants who had previously completed a study with elebsiran and BRII-179 were classified based on their anti-HBs peak levels and received 48 weeks of elebsiran combined with weekly PEG-IFNα treatment [2] Group 2 - Professor Jia Jidong, the lead investigator of the ENSURE study, emphasized the study's aim to provide scientific evidence for curative therapies for chronic hepatitis B and address key scientific questions [3] - Encouragingly, the 24-week follow-up data aligned with the results at the end of treatment, supporting the additional clinical benefits of elebsiran and indicating the potential new role of BRII-179 in activating the immune response in chronic HBV patients [3]

Core Insights - The ENSURE II study results have been published in the peer-reviewed journal Nature Medicine, evaluating the efficacy and safety of the siRNA drug elebsiran in combination with PEG-IFNα for chronic hepatitis B treatment [1] - The study also explores the potential role of the therapeutic vaccine BRII-179 in identifying immune responders and increasing HBsAg clearance rates [1] Group 1 - The ENSURE study was conducted in two parts, with the first part involving chronic HBV patients who had not previously received BRII-179, randomly assigned to either 48 weeks of PEG-IFNα monotherapy or combination therapy with elebsiran [2] - The second part involved participants who had previously received elebsiran and BRII-179, categorized based on their anti-HBs peak levels, and subsequently treated with elebsiran and PEG-IFNα [2] Group 2 - Professor Jia Jidong, the lead investigator of the ENSURE study, emphasized the study's aim to provide scientific evidence for curative therapies for chronic hepatitis B and highlighted encouraging trends in the 24-week follow-up data supporting the clinical benefits of elebsiran [3] - The study suggests a potential new role for BRII-179 in activating the immune response in chronic HBV patients, aiming for higher functional cure rates [3]

Core Insights - The core focus of the news is the publication of the ENSURE II study results, which evaluates the efficacy and safety of the siRNA drug elebsiran in combination with PEG-IFNα for the treatment of chronic hepatitis B virus (HBV) infection [1][2] Group 1: Study Overview - The ENSURE study was conducted in two parts, assessing chronic HBV patients with viral suppression [2] - In the first part, participants who had not received BRII-179 were randomly assigned to either 48 weeks of PEG-IFNα monotherapy or a combination treatment with elebsiran (administered every 4 weeks at doses of 200mg or 100mg) [2] - The second part involved participants who had previously received elebsiran combined with BRII-179, categorized based on their anti-HBs peak levels, and subsequently treated with elebsiran (100mg every 4 weeks) and weekly PEG-IFNα for 48 weeks [2] Group 2: Publication Details - The study results have been published in the peer-reviewed journal Nature Medicine, under the title "elebsiran and PEG-IFNα treatment for chronic hepatitis B virus infection: a partially randomized, open-label phase II clinical trial" [1] - The research also explores the potential role of the therapeutic vaccine BRII-179 in identifying immune responders and enhancing the HBsAg clearance rate [1]

Brii Biosciences Limited 騰盛博藥生物科技有限公司 （於開曼群島註冊成立的有限公司） （股份代號：2137） 自願性公告 在《自然•醫學》發表ENSURE II期研究結果 本公告乃由騰盛博藥生物科技有限公司（「本公司」）董事會（「董事會」）自願作出。 董事會欣然宣佈，ENSURE II期研究結果已發表於同行評審期刊《自然•醫學》。研 究評估了siRNA藥物elebsiran聯合聚乙二醇干擾素α（「PEG-IFNα」）治療方案的有 效性和安全性，並將PEG-IFNα單藥治療方案作為對照組。此外，該研究還探討了 乙型肝炎病毒（「HBV」）治療性疫苗BRII-179在識別免疫應答患者及提高乙肝表面 抗原（「HBsAg」）清除率方面的潛在作用。 標題為《elebsiran和PEG-IFNα治療慢性乙型肝炎感染：一項部分隨機、開放標籤 的II期臨床試驗》的文章現已上線。 ENSURE研究在病毒抑制的慢性HBV患者中分兩部分進行。在第一部分（隊列 1-3）中，未接受過BRII-179給藥的參與者被隨機接受48週的PEG-IFNα單藥治 療，或聯合elebsiran治療（每4週給藥一次「( Q4W」 ...