Assembly Biosciences宣布FDA快速通道指定ABI-H0731用于治疗乙型肝炎

StephenW

Assembly Biosciences Announces FDA Fast Track Designation Granted to ABI-H0731 for the Treatment of Hepatitis B Virus Infection
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July 25, 2018 07:05 ET | Source: Assembly Biosciences

INDIANAPOLIS and SAN FRANCISCO, July 25, 2018 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (NASDAQ:ASMB) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ABI-H0731 for the treatment of patients with chronic Hepatitis B infection. ABI-H0731 is Assembly’s lead oral HBV core inhibitor, which is being evaluated in two global Phase 2a proof of concept studies that are currently enrolling patients.

The Fast Track program is intended to facilitate the development and review of drug candidates that treat serious conditions and fill an unmet medical need. A drug candidate with Fast Track designation is eligible for greater access to the FDA for the purpose of expediting the drug product candidate's development, review and potential approval.

“More than one million individuals in the U.S. suffer from chronic Hepatitis B infection, which can progress to cirrhosis and liver cancer, eventually leading to death. Despite existing antiviral therapies, cures are rare, so the need for more effective and potentially curative treatments is tremendous,” said Uri Lopatin, MD, Chief Medical Officer of Assembly Biosciences. “We are encouraged that ABI-H0731 was granted Fast Track Designation. This will allow us to work closely with the FDA in our efforts to bring this new therapy to HBV patients as quickly as possible.”

Assembly recently initiated two multi-center, randomized, placebo controlled Phase 2a trials of ABI-H0731, which are actively recruiting and dosing subjects at multiple locations in the U.S. and globally. The ABI-H0731-201 “viral antigen trial” is enrolling HBeAg positive HBV patients whose viral load has already been suppressed on a standard of care nucleos(t)ide therapy. Patients will be randomized to receive either daily ABI-H0731 or placebo in addition to their continued nucleos(t)ide therapy for six months. The viral antigen trial will compare declines in HBV S antigen and HBV E antigen as well as safety and tolerability of the combination therapy to that of patients on standard-of-care nucleos(t)ide therapy alone. In the ABI-H0731-202 “viral load trial,” HBeAg positive HBV patients are being enrolled who are naïve to nucleos(t)ide treatment and will be randomized to receive either daily ABI-H0731 or placebo in combination with entecavir for six months. The viral load trial will assess the antiviral potency as measured by viral DNA suppression as well as safety and tolerability of the combination compared with entecavir alone. Initial results from both studies are anticipated in the first half of 2019.

About Assembly Biosciences
Assembly Biosciences, Inc. is a clinical-stage biotechnology company developing innovative therapeutics targeting Hepatitis B (HBV) and diseases associated with the microbiome.  The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live synthetic biotherapeutic candidates with Assembly’s fully integrated platform, including a robust process for strain identification and selection, GMP banking and production, and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology. For more information, visit assemblybio.com.

StephenW

Assembly Biosciences宣布FDA快速通道指定ABI-H0731用于治疗乙型肝炎病毒感染
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2018年7月25日07:05 ET |资料来源：Assembly Biosciences

印第安纳波利斯和旧金山，2018年7月25日（GLOBE NEWSWIRE） - Assembly Biosciences，Inc。（纳斯达克股票代码：ASMB）今天宣布，美国食品和药物管理局（FDA）已授予ABI-H0731快速通道指定用于治疗慢性乙型肝炎感染患者。 ABI-H0731是Assembly的口服HBV核心抑制剂，正在目前招募患者的两项全球2a期概念验证研究中进行评估。

快速通道计划旨在促进药物候选药物的开发和审查，以治疗严重疾病并满足未满足的医疗需求。具有快速通道指定的候选药物有资格获得更多的FDA使用权，以加快药物候选药物的开发，审查和潜在的批准。

“美国有超过一百万人患有慢性乙型肝炎感染，这种感染可导致肝硬化和肝癌，最终导致死亡。尽管现有抗病毒疗法，治疗很少见，因此需要更有效和可能治愈的治疗方法是巨大的，“装配生物科学公司首席医疗官Uri Lopatin博士说。 “我们感到鼓舞的是，ABI-H0731获得了快速通道指定。这将使我们能够与FDA密切合作，努力尽快为HBV患者提供这种新疗法。“

大会最近发起了两项多中心，随机，安慰剂对照的ABI-H0731 2a期试验，这些试验正在美国和全球多个地点积极招募和给药受试者。 ABI-H0731-201“病毒抗原试验”正在招募HBeAg阳性的HBV患者，其病毒载量已经在标准护理核苷（酸）疗法中被抑制。患者将被随机分配接受每日ABI-H0731或安慰剂以及持续的核苷酸治疗6个月。病毒抗原试验将比较HBV S抗原和HBV E抗原的下降以及联合治疗与单独使用标准治疗核苷酸（t）治疗的患者的安全性和耐受性。在ABI-H0731-202“病毒载量试验”中，正在招募的HBeAg阳性HBV患者对于核苷（酸）治疗是天真的，并将被随机分配接受每日ABI-H0731或安慰剂与恩替卡韦联合治疗6个月。病毒载量试验将评估通过病毒DNA抑制测量的抗病毒效力以及与单独的恩替卡韦相比组合的安全性和耐受性。两项研究的初步结果预计在2019年上半年。

关于装配生物科学
Assembly Biosciences，Inc。是一家临床阶段的生物技术公司，开发针对乙型肝炎（HBV）和与微生物组相关的疾病的创新疗法。 HBV计划的重点是推进一类新的强效口服核心抑制剂，这些抑制剂有可能提高慢性感染患者的治愈率。微生物组计划正在开发具有Assembly完全集成平台的新型口服活合成生物治疗候选药物，包括用于菌株鉴定和选择的强大过程，GMP库和生产，以及使用GEMICEL®技术靶向递送至下胃肠道。有关更多信息，请访问assemblybio.com。

边缘

Assembly Biosciences Announces ABI-H0731 Phase 1b Interim Data Accepted as a Late-Breaker Poster at The International Liver Congress™ (EASL)
March 28, 2018 at 5:30 AM EDT
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INDIANAPOLIS and SAN FRANCISCO, March 28, 2018 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (NASDAQ:ASMB), a clinical-stage biotechnology company advancing a new class of oral therapeutics for the treatment of hepatitis B virus (HBV) infection and novel oral live biotherapeutics for disorders associated with the microbiome, today announced the publication of a late-breaker abstract and planned poster presentation of the Phase 1b clinical trial of ABI-H0731 evaluating safety, tolerability and antiviral activity in subjects with chronic HBV at The International Liver Congress™, the Annual Meeting of the European Association for the Study of the Liver (EASL) being held April 11-15, 2018, in Paris. The abstract includes the preliminary data available from 49 healthy volunteers and patients at the time of submission (February 2018). At EASL, the company intends to present an expanded dataset including three healthy subject cohorts (n=30) and three HBV patient cohorts (n>30) treated with ABI-H0731.

“We are pleased to report that initial results of our ongoing Phase 1b study of ABI-H0731 show an attractive safety profile and significant antiviral potency in both HBeAg positive and negative patients, with viral DNA reductions increasing with increasing dose levels,” said Richard Colonno, PhD, Assembly’s executive vice president and chief scientific officer of virology operations. “An important study objective is to identify the minimal dose that produces maximum efficacy of ABI-H0731. We believe we have identified the dose level sufficient to suppress cccDNA establishment and move forward into Phase 2a proof of concept studies this summer.”

Initial patient data from the ongoing Phase 1b study indicate that ABI-H0731 demonstrates potent antiviral activity with once daily dosing for 28 days, is generally safe and well tolerated, and exhibits increasing plasma exposures with increasing dose. At 100 mg per day, the lowest dose tested, HBV declines of 1.3 and 2.2 log10 IU/mL were observed in HBeAg positive and negative patients (respectively). Declines up to approximately 4 logs in HBeAg negative patients were observed following administration of 400 mg per day. HBV RNA reductions were generally proportional to reductions of plasma HBV DNA. No serious adverse events (AEs) and no dose limiting laboratory toxicities were observed. A single Grade 3 treatment-emergent AE (TEAE) leading to drug discontinuation was seen in one patient at the 400 mg dose, otherwise all TEAEs were mild (Grade 1) and/or unrelated to study drug. Over 60 healthy volunteers and patients have been dosed to date, with no dose limiting side effects.

newchinabok

好激动，虽然不一定治愈乙肝，但核苷和核衣壳降肝癌发病率可以期待的。因为抗病毒好比装了两个水龙头，抗病毒强度变大了

newchinabok

快速通道（Fast Track）
由制药企业主动申请（可以在药物研发的任何阶段），FDA在收到申请后6个月内给出答复。对进入快速通道的药物，FDA将进行早期介入，就哪些试验该做哪些试验可以不做等内容提出指导意见，以达到让该产品在研发过程中少走弯路，加快整个研发过程的效果。另外，药企还可分阶段递交申报资料，而不需要一次性递交全部材料才进行审评。

newchinabok

恭喜！Assembly在研乙肝药ABI-H0731获FDA快速通道认定

原创： 略晓薛  肝脏时间  今天


专注于新型乙肝药物及人体微生物菌群失调疾病口服生物疗法开发的生物科技公司 Assembly Biosciences 7月25日宣布，美国FDA已经授予公司用于慢性乙型肝炎病毒（HBV）感染治疗的在研乙肝候选药物 ABI-H0731 快速通道认定。

ABI-H0731 是 Assembly Biosciences 公司口服治疗HBV感染的核心蛋白抑制剂，目前正在进行两项全球 Phase 2a 期临床概念验证研究，而相应的患者也正在招募中。

快速通道审评的设立主要是为了促进治疗重大疾病药物或未满足临床需求药物开发，通过加快药物审评的过程而使这些药物能更早一点到达患者手中。

“美国有一百多万的慢性乙肝病毒感染者，其可发展为肝硬化和肝癌，最终导致死亡。尽管已有抗病毒疗法，但要想彻底治愈该疾病仍比较困难，因此需要更有效和强力的治疗方法。”Assembly Biosciences 首席医学官 Uri Lopatin 博士表示。“令我们感到鼓舞的是，ABI-H0731被授予了快速通道认定，这将使我们能够与FDA密切合作，努力尽快将这种新的治疗方法应用于乙肝病毒患者。”

Assembly Biosciences 最近启动了两项针对在研乙肝新药 ABI-H0731 的多中心、随机、安慰剂对照 Phase 2a 期临床试验，这些试验正在美国和全球多个中心积极招募患者并开始用药。

其中 ABI-H0731-201“病毒抗原试验”正在招募病毒载量已经被标准的核苷（酸）类似物抑制的 HBeAg 阳性乙肝病毒感染患者。患者将随机接受每日 ABI-H0731或安慰剂同时辅以持续6个月的核苷（酸）类似物治疗。病毒抗原试验将比较联合治疗跟标准核苷（酸）类似物单药治疗对HBV S抗原和HBV E抗原的下降，以及安全性和耐受性情况。

ABI-H0731-202“病毒载量试验”招募的对象为未接受过核苷（酸）类药物治疗的 HBeAg 阳性的HBV患者，患者将随机接受每日 ABI-H0731 或安慰剂联合恩替卡韦治疗6个月。病毒载量试验将评估联合用药及恩替卡韦单药治疗对病毒DNA抑制的抗病毒能力，及安全性和耐受性情况。这两项研究的初步结果预计将在2019年上半年完成。

此外，公司还在5月份推出了二代在研乙肝新药——核心蛋白变构调节剂(CpAM)ABI-H2158，该新药预计将于2018年第四季度在健康志愿者中进行Phase 1a期临床试验

V友

灵魂不屈

期待！感谢分享！

pourvivre

好东西 希望成功

newchinabok

pourvivre 发表于 2018-7-27 11:21
好东西 希望成功

已经成功，只时间到位就会上市