丁型肝炎病毒（HDV）治疗Lonafarnib -

StephenW

Eiger Bio Announces Positive Data in Patients Infected with Hepatitis Delta Virus (HDV) Treated with Lonafarnib - Results Presented at American Association for the Study of Liver Diseases (AASLD) Meeting


PALO ALTO, Calif., Dec, 22, 2014 /PRNewswire/ -- Eiger BioPharmaceuticals Incorporated announced the positive results of a Phase 2a study of lonafarnib in patients with chronic hepatitis delta virus (HDV) infection.  The study was conducted at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland.  The double-blinded, randomized, placebo-controlled, dose ascending study evaluated two doses of lonafarnib, 100 mg twice daily and 200 mg twice daily for 28 days.  "This proof-of-concept study is the first ever to evaluate lonafarnib, the first of a class of novel antiviral agents known as prenylation inhibitors, in patients infected with HDV," said David Cory, President and Chief Executive Officer of Eiger.  "Hepatitis Delta is the most severe form of human viral hepatitis and a therapy is sorely needed."

A significant decrease in HDV RNA viral levels was observed after treatment with lonafarnib for 28 days compared with placebo, including a statistically significant dose-dependent difference in decline in HDV RNA virus between the 100 mg twice daily and 200 mg twice daily doses compared with placebo.  The decline in HDV RNA viral levels significantly correlated with serum lonafarnib drug levels, providing further evidence for the efficacy of lonafarnib in chronic HDV.  In the study, lonafarnib was generally well tolerated, with the most common adverse events in the treatment group being gastrointestinal related.  "The NIH Clinical Center has completed a study with significant implications for treatment of chronic hepatitis D, which often leads to cirrhosis and other life-threatening conditions," said Theo Heller, MD, a Principal Investigator at the NIH.  "We look forward to continued collaboration to potentially deliver an approved therapy to patients."

About Lonafarnib
Lonafarnib is a well-characterized, late stage, orally active inhibitor of farnesyl transferase, an enzyme involved in modification of proteins through a process called prenylation. HDV uses this host cell process inside liver cells to complete a key step in its life cycle. Lonafarnib inhibits the prenylation step of HDV replication inside liver cells and blocks the ability of the virus to multiply.  Since prenylation is a host process, not under control of HDV, and lonafarnib inhibits prenylation, there is also a theoretical higher barrier to resistance with lonafarnib therapy.  Virus mutation, a common pathway to drug resistance, is not expected to be a potential pathway to lonafarnib resistance by HDV.

Lonafarnib is not approved for sale for any indication.

About Hepatitis Delta
Hepatitis Delta is caused by infection with the hepatitis D virus (HDV) and is considered to be the most severe form of viral hepatitis in humans. Hepatitis D occurs only as a co-infection in individuals with hepatitis B (HBV), leads to more severe liver disease than HBV alone, and is associated with accelerated liver fibrosis, liver cancer, and liver failure. HDV is a disease with a significant impact on global health affecting ~15 million people worldwide. The prevalence of HDV varies between different parts of the world. HDV meets criteria for Orphan Designation in the United States (less than 200,000 people), Europe (less than 5 in 100,000 people), and Japan (less than 50,000 people).  Globally, HDV infection is reported to be present in approximately 4% - 6% of chronic hepatitis B carriers. In some parts of the world, including certain areas of China, Russia, Central Asia, Turkey, Africa, and South America, prevalence as high as 40% has been reported in HBV infected patients.

About Eiger
Eiger is a privately held biotechnology company focused on the research, development and commercialization of innovative therapies in viral hepatitis.  The company is focused on developing lonafarnib for the treatment of Hepatitis Delta Virus (HDV), the most severe form of viral hepatitis.  Lonafarnib is not approved for sale.  Eiger's research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious liver diseases.  For additional information about Eiger and its R&D pipeline, please visit www.eigerbio.com.

Investors: Jim Shaffer, Eiger Bio, Inc., 919-345-4256, [email protected]

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SOURCE Eiger BioPharmaceuticals, Inc.

StephenW

艾格峰生物公布正面数据的患者感染丁型肝炎病毒（HDV）治疗Lonafarnib - 结果被提出在美国协会肝病研究（AASLD）会议


帕洛阿尔托，加利福尼亚州，月，22，2014年/新华美通/ - 艾格峰生物制药股份有限公司宣布lonafarnib的2a期研究的阳性结果在慢性丁型肝炎病毒（HDV）感染。这项研究是在美国国立卫生研究院（NIH）在马里兰州贝塞斯达的临床中心进行。在双盲，随机，安慰剂对照，剂量递增研究评估两种剂量lonafarnib，100毫克，每天两次，200毫克，每天28天两次。 “概念证明型的这项研究是有史以来第一次评估lonafarnib，第一类被称为异戊烯化抑制剂新颖的抗病毒药剂，患者感染HDV，”大卫·科里，总统和艾格峰的首席执行官说。 “丁型肝炎是人类病毒性肝炎的最严重的形式和治疗是非常必要的。”

在HDV RNA病毒水平则显著下跌与lonafarnib28天，与安慰剂相比，包括在下降，100毫克之间HDV RNA病毒有统计学显著剂量依赖性差治疗后观察到每天两次200毫克，每天两次服用安慰剂组。在HDV RNA病毒水平的下降与血清lonafarnib药物水平显著相关，提供了进一步的证据lonafarnib慢性HDV的疗效。在这项研究中，lonafarnib一般耐受性良好，与治疗组是胃肠道相关的最常见的不良事件。 “美国国立卫生研究院临床中心已经完成了治疗慢性丁型肝炎，这往往会导致肝硬化和其他危及生命的条件显著影响的研究，”西奥海勒，医学博士，首席研究员，在美国国立卫生研究院说。 “我们期待着继续合作，有可能提供一个批准治疗的患者。”

关于Lonafarnib
Lonafarnib是充分表征的，晚期，法尼基转移酶，通过一种称为异戊烯化过程涉及的蛋白修饰酶的口服活性抑制剂。 HDV使用的肝细胞内这种宿主细胞的过程中，完成在其生命周期的关键一步。 Lonafarnib抑制HDV复制的异戊烯化步骤的肝细胞和块内的病毒的繁殖能力。自异戊烯化是一个主机进程，而不是根据HDV的控制，并且lonafarnib抑制异戊烯化，还存在一个理论更高屏障阻力lonafarnib疗法。病毒突变，共同途径耐药性，预计不会是一个潜在的途径由HDV到lonafarnib阻力。

Lonafarnib没有批准销售的任何迹象。

关于丁型肝炎
丁型肝炎与丁型肝炎病毒（HDV）引起的感染，并被认为是病毒性肝炎在人类的最严重的形式。丁型肝炎发生只作为共感染乙型肝炎病毒（HBV）的个体，导致更严重的肝脏疾病比单独的HBV，并与加速肝纤维化，肝癌和肝衰竭有关。 HDV是一种疾病与全球健康影响全球〜1500万人一个显著的影响。 HDV的患病率在世界不同地区之间的差异。 HDV满足孤儿名称在美国（低于200,000人），欧洲（小于5的10万人），日本（少于50000人）的标准。全球范围内，HDV感染报道存在于约4％ - 慢性乙肝病毒携带者的6％。在世界的一些地区，包括中国，俄罗斯，中亚，土耳其，非洲和南美洲的某些地区，40％有报道在HBV感染者患病率较高。

关于艾格峰
艾格峰是一家私人持有的生物技术公司，专注于创新治疗病毒性肝炎的研究，开发和商业化。该公司专注于开发lonafarnib为丁型肝炎病毒治疗（HDV），病毒性肝炎的最严重的形式。 Lonafarnib未被批准可以转让。艾格峰的研究项目主要集中在有针对性的，小分子疗法和生物标志物治疗和监测严重的肝脏疾病的发现。有关艾格峰和它的R＆D管道的更多信息，请访问www.eigerbio.com。

投资者：吉姆·谢弗，艾格峰生物公司，919-345-4256，[email protected]

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