Lonafarnib的组合与利托那韦或聚乙二醇化干扰素的患者感染丁

StephenW

Eiger Bio Announces Interim Results of Lonafarnib in Combination with Ritonavir or Pegylated Interferon in Patients Infected with Hepatitis Delta Virus (HDV)


Eiger - Leader in HDV

– Results Presented at European Association for the Study of the Liver (EASL) Meeting in Vienna, Austria

PALO ALTO, Calif., April 27, 2015 /PRNewswire/ -- Eiger BioPharmaceuticals, Incorporated today announced the presentation of interim results of Phase 2 data of lonafarnib in patients with chronic hepatitis delta viral (HDV) infection. Data were presented from the LOWR HDV program, enrolled at Ankara University Medical School, Turkey, in a country where HDV is endemic.

LOWR HDV - 1 (LOnafarnib With and without Ritonavir-1) is a parallel dose comparison study which randomized subjects to receive different doses of lonafarnib with or without ritonavir or pegylated interferon for four to twelve weeks. Interim data from 15 subjects who received lonafarnib alone or with ritonavir boosting or in combination with pegylated interferon all led to decreased viral loads.  High doses (200 mg twice daily or 300 mg twice daily) of lonafarnib resulted in 1.6 and 2.0 log decline in viral loads after 4 weeks of treatment, respectively. A lower dose of lonafarnib (100 mg twice daily) with 100 mg daily ritonavir boosting or in combination with 180 mcg once weekly of pegylated interferon resulted in a 2.2 and a 1.8 log decline in viral load at week 4, respectively. At week 8, the mean viral load declines were 3.2 and 3.0 logs for subjects on lonafarnib with ritonavir or lonafarnib with pegylated interferon, respectively.

The most frequently observed adverse events in LOWR-1 were anorexia, nausea, diarrhea, fatigue, and weight loss, and these appeared to be dose-dependent.

LOWR HDV - 2 (LOnafarnib With Ritonavir-2) was recently initiated to test a range of doses of lonafarnib boosted by ritonavir, with the aim to identify optimal combination(s) for the next longer-term studies.

"The data generated thus far investigating lonafarnib combinations are very encouraging," said Cihan Yurdaydin, MD, Principal Investigator, Ankara University Medical School. "We continue to conduct dose finding with lonafarnib boosted by ritonavir to identify the optimal balance of efficacy and tolerability, with a goal of viral clearance."

About Lonafarnib
Lonafarnib is a well-characterized, late stage, orally active agent targeting farnesyltransferase, an enzyme involved in modification of proteins through a process called prenylation. HDV uses this host cellular 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 virus life cycle at the stage of assembly. Since prenylation is carried out by a host enzyme there is a theoretical higher barrier to develop viral resistance mutations to lonafarnib therapy.

Lonafarnib has been granted Orphan Drug Designation by the US FDA and the European Medicines Agency (EMA), and Fast Track designation by US FDA. Lonafarnib is an investigational product and its safety and efficacy have not yet been established for any indication. Lonafarnib is licensed from Merck Sharp & Dohme Corp. (known as MSD outside the United States and Canada).

About HDV
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 harboring hepatitis B virus (HBV). Hepatitis D leads to more severe liver disease than HBV alone, and is associated with accelerated liver fibrosis, liver cancer, and liver failure. Hepatitis D 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. Globally, HDV infection is reported to be 5-6% of chronic hepatitis B carriers. In some parts of the world, including certain areas of China, Mongolia, Russia, Central Asia, Turkey, Africa, and South America, HDV prevalence as high as 70% 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. For additional information about Eiger and its R&D pipeline, please visit www.eigerbio.com.

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

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SOURCE Eiger BioPharmaceuticals, Inc.

StephenW

艾格峰生物宣布Lonafarnib的组合与利托那韦或聚乙二醇化干扰素的患者感染丁型肝炎病毒中期业绩（HDV）


艾格峰 - 领先的HDV

- 提出在欧洲协会为肝脏研究（EASL）会议在奥地利维也纳结果

帕洛阿尔托，加利福尼亚州，2015年4月27日/新华美通/ - 艾格峰生物制药，今天宣布成立的lonafarnib的第2阶段的数据中期业绩慢性丁型肝炎病毒（HDV）感染的表现。数据提出了从LOWR HDV节目，就读于安卡拉大学医学院，土耳其，在一个国家里HDV流行。

LOWR HDV - 1（LOnafarnib具备和不具备利托那-1）是一种随机化受试者接受不同剂量lonafarnib的有或无利托那韦或聚乙二醇干扰素四个至十​​二个星期一个平行剂量比较研究。从15名受试者临时数据谁收到lonafarnib单独或与利托升压或与聚乙二醇干扰素所有导致降低病毒负荷。高剂量（200毫克，每天两次或300毫克，每天两次）lonafarnib的结果是1.6和2.0日志下滑的病毒载量分别为4周治疗后。较低剂量lonafarnib（100毫克，每天两次）用100mg每日利托升压或与180微克一次聚乙二醇干扰素每周联合获得了2.2，并在4周1.8日志下降病毒载量，分别。在第8周，平均病毒载量下降分别为3.2和3.0日志科目上lonafarnib与利托那韦或lonafarnib聚乙二醇干扰素，分别。

在LOWR-1的最常观察到的不良反应是厌食，恶心，腹泻，疲劳，体重减轻，并且这些似乎是剂量依赖性的。

LOWR HDV - 2（LOnafarnib与利托那韦-2）最近开始测试一系列剂量lonafarnib由利托那韦推动的，其目的在于确定最佳组合（S）为下一个更长期的研究。

“产生迄今调查lonafarnib组合的数据是非常令人鼓舞的，”吉汗Yurdaydin，医学博士，首席研究员，安卡拉大学医学院说。 “我们将继续进行剂量发现与lonafarnib通过利托那韦推动查明疗效和耐受性的最佳平衡，与病毒清除的目标。”

关于Lonafarnib
Lonafarnib是充分表征的，晚期，靶向法尼基转移酶，通过一种称为异戊烯化过程参与蛋白质修饰酶口服活性剂。 HDV使用的肝细胞内的这种宿主细胞的过程，以完成其生命周期的关键一步。 Lonafarnib抑制HDV复制的异戊二烯化步骤的肝细胞，并阻止病毒的生命周期内，在装配阶段。自异戊烯化是通过宿主酶是有理论更高屏障来开发病毒抗性突变lonafarnib疗法。

Lonafarnib已获得孤儿药通过了美国FDA和欧洲药品管理局（EMA），并通过美国FDA快速通道标识。 Lonafarnib是一种研究产品及其安全性和疗效尚未确立为任何指示。 Lonafarnib从默沙东公司（被称为MSD以外的美国和加拿大）的许可。

关于HDV
肝炎三角洲与丁型肝炎病毒（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。丁型肝炎只发生作为共感染的个体携带乙型肝炎病毒（HBV）。丁型肝炎导致更严重的肝脏疾病比HBV单独和与加速肝纤维化，肝癌和肝衰竭有关。丁型肝炎是一种疾病对全球健康影响的全球〜1500万人一个显著的影响。 HDV的患病率在世界的不同部分之间变化。从全球来看，HDV感染据报道，慢性乙肝携带者5-6％。在世界一些地区，包括中国，蒙古，俄罗斯，中亚，土耳其，非洲和南美洲的某些地区，HDV感染率高达70％，据报道，在乙肝病毒感染者。

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。有关艾格峰和研发渠道的更多信息，请访问www.eigerbio.com。

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

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来源艾格峰生物制药公司