Arbutus Gets Clearance to Initiate Hepatitis Study, Stock Up

Arbutus计划启动乙型肝炎病毒候选药AB-729临床试验,股价上涨37.2%

2019-06-24 14:37:00 Zacks

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Arbutus Biopharma Corporation ABUS received regulatory clearance to initiate a phase Ia/Ib study to evaluate its hepatitis B virus candidate, AB-729. Shares of Arbutus surged 37.2% on Jun 20 following the announcement, presumably due to earlier-than-expected study initiation. However, the company’s shares have decreased 41% so far this year against the industry’s rise of 5.5%. Please note that a regulatory authority had requested the company last month to complete three- and six-month toxicology studies on AB-729 before initiating the aforementioned study. This was likely to delay the initiation of the early-stage clinical study on the candidate. However, the company submitted a revised protocol for the study and received a go ahead from the authority. The company is planning to start the study soon. The phase Ia/Ib study is a single and multiple dose clinical study, which will evaluate subcutaneous administration of AB-729 in healthy volunteers followed by patients with chronic hepatitis B infection. The candidate is an RNAi agent, which inhibits HBV replication and reduces HBsAg antigen production. Reduction in HBsAg antigen levels are believed to be a pre-requisite for activating the body’s immune system to respond to the virus. The company has another early-stage HBV candidate, AB-506, an oral capsid inhibitor, in its pipeline. Top-line data from an interim analysis of the phase Ia/Ib study evaluating AB-506 is expected in July 2019. The company is also planning to initiate a dose finding phase IIa study on the candidate in the second half of this year. It is also planning to evaluate a combination AB-729 and AB-506 in clinical study in HBV patients. The company anticipates the combination therapy could result in profound inhibition of HBV replication and reduction in HBsAg antigen levels. In the fourth quarter of 2018, the company discontinued development of another RNAi candidate, AB-1467, which was being evaluated in a mid-stage study in combination with Gilead’s GILD Viread (tenofovir) and PEG-IFN in HBV patients. The company discontinued the development of AB-1467 to focus on AB-729 as the latter has the potential to achieve more durable HBsAg reduction. The company also has several pre-clinical candidates targeting HBV in its portfolio. A clinical study on newly discovered oral RNA-destabilizer, AB-452, is expected in early 2020. Arbutus is also focused on strengthening its senior management by appointing executives with experience at large pharma companies. Earlier this week, the company announced the appointment of William H. Collier as the president and chief executive officer. Collier has more than 30 years of experience in the pharmaceutical industry. Prior to joining Arbutus, he served as the president of ViiV Healthcare North America. ViiV Healthcare is a joint venture between Glaxo GSK and Pfizer PFE. Last year, the company had appointed Gaston Picchio as its chief development officer, who held several high level management positions at Janssen, a subsidiary of Johnson & Johnson. The HBV segment is competitive with several large pharma companies showing interest in developing treatments. There are also multiple therapies approved for the disease. Rapid pipeline progress and management should help the company survive in a competitive environment. Arbutus Biopharma Corporation Price Arbutus Biopharma Corporation price | Arbutus Biopharma Corporation Quote Zacks Rank Arbutus currently carries a Zacks Rank #3 (Hold).
abutus Biopharma Corporation ABUS 获得监管许可,开始进行 Ia / Ib 期研究,以评估其乙型肝炎病毒候选株 AB-729。 在宣布这一消息后, Arbutus 的股价在6月20日上涨了37.2%,大概是因为研究启动时间早于预期。然而,该公司股价今年迄今已下跌41%,而该行业的涨幅为5.5%。 请注意,一个监管机构已要求该公司在上个月完成三个月和六个月的毒理学研究 AB-729之前启动上述研究。这可能会推迟对候选人进行早期临床研究。不过,该公司提交了一份修订后的研究方案,并获得了当局的批准。该公司计划很快开始这项研究。 Ia / Ib 期临床研究是一项单剂量、多剂量的临床研究,将评价 AB-729在健康志愿者中的皮下给药情况,随后是慢性乙肝感染患者。候选药物为 RNAi ,可抑制 HBV 复制,减少 HBsAg 抗原的产生。降低 HBsAg 抗原水平被认为是激活人体免疫系统对病毒作出反应的先决条件。 该公司还有另一位早期乙肝病毒候选药物 AB-506,一种口服壳聚糖抑制剂,正在酝酿中。评估 AB-506的 Ia / Ib 阶段研究中期分析的一线数据预计将于2019年7月公布。该公司还计划在今年下半年启动对该候选人的剂量发现阶段 IIa 研究。它还计划评估 AB-729和 AB-506联合应用于乙肝患者的临床研究。该公司预计,联合治疗可能导致乙肝病毒复制的深度抑制和 HBsAg 抗原水平的降低。 2018年第四季度,公司终止了另一位 RNAi 候选者 AB-1467的研发,该研发正在与吉利德(Gilead)公司的 GILD Viread (替诺福韦)和 PEG-IFN 联合在 HBV 患者中进行中期研究评估。由于 AB-729具有实现更持久 HBsAg 还原的潜力,公司终止了 AB-1467的开发,将重点放在 AB-729上。该公司还在其产品组合中有几个针对 HBV 的临床前候选者。新发现的口服 RNA 稳定剂 AB-452有望在2020年初进行临床研究。 Arutus 还专注于通过任命在大型制药公司有经验的高管来加强其高级管理层。本周早些时候,该公司宣布任命 WilliamH.Collier 为总裁兼首席执行官。高力拥有30多年医药行业经验。在加入 Arutus 之前,他曾担任 ViiV Healthcare 北美总裁。ViiV Healthcare 是葛兰素史克(GSK)与辉瑞(Pfizer) PFE 的合资企业。去年,该公司任命 GastonPicchio 为其首席开发官,他曾在强生的子公司杨森(Janssen)担任多个高级管理职位。 乙肝病毒部分是竞争与几个大型制药公司显示出兴趣发展治疗。也有多种治疗方法被批准的疾病。管道的快速发展和管理应有助于公司在竞争环境中生存。 扎克斯排名 Arubutus 目前拥有 Zacks 排名第3(保留)。

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