- Vebicorvir (VBR or ABI-H0731): Assembly Bio’s lead core inhibitor candidate
- HBV field’s first core inhibitor combination study (Study 211) to assess off-treatment response did not achieve a meaningful rate of sustained virologic response (SVR) as 39 of 41 patients have relapsed.
- Assembly Bio to host webcast and conference call today at 5:00 p.m. ET. The live audio webcast may be accessed through the “Events & Presentations” page in the “Investors” section of Assembly Bio’s website at https://investor.assemblybio.com/events-presentations.
- For more information, see the data press release “Assembly Bio Provides Update on the Ongoing Phase 2 Extension Study of Vebicorvir in Patients with Chronic Hepatitis B Virus Infection” issued today, available on Assembly Bio’s website.
- Reached agreement with the Chinese regulatory body, National Medical Products Administration, Center for Drug Evaluation, and advanced discussions with the U.S. Food and Drug Administration (FDA) on a Phase 3 registrational program for VBR as a chronic suppressive therapy (CST) for HBV infection.
- Entered into a license and collaboration agreement with BeiGene, Ltd. for Assembly Bio’s portfolio of three clinical-stage core inhibitors (VBR, ABI-H2158, ABI-H3733) in the China territory, including Hong Kong, Macau and Taiwan.
- Entered into a clinical trial collaboration agreement with Arbutus Biopharma Corporation to evaluate the triple combination of VBR, RNAi therapeutic AB-729 and standard-of-care NrtI therapy in patients with chronic HBV infection.
- Presented clinical data for Assembly Bio’s HBV core inhibitors in an oral presentation and three posters at EASL 2020 The Digital International Liver Congress™.
- ABI-H2158 (2158): Assembly Bio’s second core inhibitor candidate
- Continued to enroll patients in the ongoing multi-center, randomized, placebo-controlled Phase 2 trial to evaluate 2158 with entecavir versus placebo with entecavir in treatment naïve patients with HBeAg positive chronic HBV infection.
- ABI-H3733 (3733): Assembly Bio’s third core inhibitor candidate
- Continued the ongoing Phase 1 trial to evaluate the safety, tolerability, and pharmacokinetics following single ascending dose and multiple ascending dose administrations in healthy subjects.
Corporate Highlights - Appointed Gina Consylman to the Board of Directors and Audit Committee in October 2020.
Anticipated Milestones and Events HBV Portfolio - Four abstracts, including two late-breaking submissions, will be presented at the annual meeting of the American Association for Liver Diseases (AASLD), The Liver Meeting® Digital Experience (TLMdX) being hosted virtually November 13-16, 2020.
- Vebicorvir
- Phase 3 registrational studies for CST expected to initiate in H1 2021 in collaboration with BeiGene.
- Phase 2 triple combination study with Arbutus Biopharma expected to initiate in H1 2021.
- Phase 2 triple combination study evaluating the addition of interferon to VBR and NrtI expected to initiate in H1 2021.
- Interim data from Phase 2 intensification study in partially virologically suppressed patients anticipated in 2021.
- 2158
- Interim data from Phase 2 study anticipated in 2021.
Vebicorvir（VBR或ABI-H0731）：Assembly Bio的领先核心抑制剂候选HBV field的第一个核心抑制剂组合研究（211号研究）评估非治疗反应没有获得有意义的持续病毒应答率（SVR），因为41名患者中有39名复发。
Assembly Bio将于美国东部时间下午5:00主持网络广播和电话会议。可通过Assembly Bio网站“Investors”部分的“Events&Presentations”页面访问现场音频网络广播https://investor.assemblybio.com/events-presentations。
欲了解更多信息，请参阅今日发布的数据新闻稿“Assembly Bio提供了维比科韦在慢性乙型肝炎病毒感染患者中进行的第2阶段扩展研究的最新情况”，可在Assembly Bio的网站上获得。
与中国监管机构、国家医药产品管理局、药品评价中心达成协议，并与美国食品药品监督管理局（FDA）就VBR作为HBV感染的慢性抑制疗法（CST）的第三阶段注册计划进行了深入讨论。
与Biigne公司签订许可证和合作协议，用于在中国地区包括香港、澳门和台湾的三个临床阶段核心抑制剂（VBR，ABI H2158，ABI H37 33）的组装生物组合。
与杨梅生物制药公司签订临床试验合作协议，以评估VBR、RNAi治疗AB-729和护理标准NrtI治疗对慢性乙型肝炎病毒感染患者的治疗效果。
在EASL 2020数字国际肝脏大会上，以口头报告和三张海报展示了Assembly Bio的HBV核心抑制剂的临床数据™.
ABI-H2158（2158）：Assembly Bio的第二个核心抑制剂候选品
继续纳入正在进行的多中心、随机、安慰剂对照的2期试验，以评估2158例恩替卡韦与安慰剂联合恩替卡韦治疗HBeAg阳性慢性HBV感染的初发患者。
ABI-H3733（3733）：Assembly Bio的第三种核心抑制剂候选品
继续进行正在进行的1期试验，以评估健康受试者单次和多次递增剂量给药后的安全性、耐受性和药代动力学。
企业亮点
于2020年10月任命Gina Consylman为董事会和审计委员会成员。
预期里程碑和事件
HBV投资组合
四篇摘要，包括两篇迟交的论文，将在美国肝病协会（AASLD）年会上发表，该年会将举办肝脏会议®数字体验（TLMdX），该会议将于2020年11月13日至16日举行。
维比科韦
CST的第三阶段注册研究预计于2021年上半年与BeiGene合作启动。
第二阶段三联用杨梅生物制药研究预计于2021年上半年启动。
第二阶段三重联合研究评估干扰素在VBR和NrtI中的添加，预计将于2021年上半年启动。
预计2021年对部分病毒学抑制患者的第2阶段强化研究的中期数据。
2158
预计2021年第2阶段研究的中期数据。
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发表于 2020-11-6 16:12
