Eiger BioPharmaceuticals今天宣布，已经提交了干扰素Lambda治疗D型

StephenW

PALO ALTO, Calif., May 3, 2017 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (EIGR), focused on the development and commercialization of targeted therapies for rare diseases, announced today that the U.S. IND has been filed for Pegylated Interferon Lambda in the treatment of hepatitis delta virus (HDV) infection.  U.S. sites are planned for the ongoing Phase 2 LIMT HDV (Lambda Interferon MonoTherapy in HDV) study, a monotherapy trial of pegylated interferon lambda 1a ("Lambda") as a potential treatment for chronic hepatitis D virus (HDV) infection.  

"Filing the U.S. IND for Lambda in the treatment of HDV is a strategic imperative for Eiger," said Shelly Xiong, PhD, RAC, Senior Vice President of Regulatory Affairs at Eiger. "This filing should facilitate discussions with the agency regarding potential Lambda development and registration pathways for HDV as well as expanding the program to U.S. investigators and U.S. patients."

"Over recent years, patients with chronic hepatitis B and hepatitis C have benefited from huge advances in antiviral therapy for both diseases.  Unfortunately HDV remains a large unmet medical need because of the lack of any effective therapy for this most aggressive form of viral hepatitis.  In many countries, HDV presents a real public health challenge," said Eduardo Martins, MD, DPhil, Senior Vice President of Liver and Infectious Diseases Development at Eiger.  "We look forward to expanding our HDV development program to include Lambda monotherapy and potential combinations, including lonafarnib."

About the LIMT HDV Phase 2 Study
LIMT HDV is a 1:1 randomized, open-label study of Lambda 120 or 180 microgram subcutaneous injections administered weekly for 48 weeks in approximately 30-40 patients with chronic HDV.  End of treatment will be followed by a treatment-free 24-week observation period.  The primary objective of the phase 2 study is to evaluate the safety, tolerability, and efficacy of treatment with two dose levels of Lambda monotherapy in patients with chronic HDV infection.  All patients will also be administered an anti-hepatitis B virus nucleos(t)ide analog throughout the study.  LIMT HDV is an international study currently enrolling at sites in New Zealand, Israel and Pakistan.

About Pegylated Interferon Lambda 1a
Pegylated interferon lambda 1a ("Lambda") is a well-characterized, late-stage, first in class, type III interferon (IFN) that stimulates immune responses that are critical for the development of host protection during viral infections.  Lambda targets type III IFN receptors which are distinct from the type I IFN receptors targeted by IFN alfa.  These type III receptors are highly expressed on hepatocytes with limited expression on hematopoietic and central nervous system cells, which may reduce the off-target effects associated with other IFNs and improve the tolerability of Lambda.  Although Lambda does not use the IFN alfa receptor, signaling through either the IFN lambda or IFN alfa receptor complexes results in the activation of the same Jak-STAT signal transduction cascade.

Eiger licensed worldwide rights to Lambda from Bristol-Myers Squibb in April 2016.  Lambda has been administered in HBV / HCV clinical trials involving over 3,000 subjects.  Lambda has not been approved for any indication.
About Hepatitis Delta Virus (HDV)
Hepatitis Delta (or Hepatitis D) is caused by infection with HDV and is considered to be one of the most severe forms of viral hepatitis in humans.  Hepatitis delta occurs only as a co-infection in individuals harboring Hepatitis B Virus (HBV).  Hepatitis delta leads to more severe liver disease than HBV alone and is associated with accelerated liver fibrosis, liver cancer, and liver failure.  Hepatitis delta is a disease with a significant impact on global health, which may affect up to approximately 15-20 million people worldwide.  The prevalence of HDV varies among different parts of the world.  Globally, HDV infection is reported to be present in approximately 4.3% to 5.7% of chronic Hepatitis B carriers.  The prevalence of HDV in patients infected with chronic HBV is even higher in certain regions, including certain parts of Mongolia, China, Russia, Central Asia, Pakistan, Turkey, Africa, and South America, with an HDV prevalence as high as 60% being reported in HBV-infected patients in Mongolia and Pakistan.

StephenW

加利福尼亚州PALO ALTO，2017年5月3日/美通社/ - Eiger BioPharmaceuticals，Inc.
Eiger BioPharmaceuticals，Inc。，今天宣布，已经提交了干扰素Lambda在治疗乙型肝炎病毒（HDV）感染针对罕见疾病的靶向治疗的商业化，今天宣布，美国IND已经提交了聚乙二醇化干扰素Lambda治疗乙型肝炎病毒（HDV）感染。美国网站计划进行正在进行的第2阶段LIMT HDV（Lambda Interferon MonoTherapy in HDV）研究，聚乙二醇化干扰素λ1a（“Lambda”）作为慢性戊型肝炎病毒（HDV）感染的潜在治疗的单一疗法试验。

Eiger法规事务高级副总裁Shelly熊博士说：“为了处理HDV而向美国IND提出申请是艾格峰的战略重要。 “这个文件应该促进与机构讨论有关潜在的Lambda开发和登记路径的HDV，并将该计划扩大到美国调查员和美国患者。

“近年来，慢性乙型肝炎和丙型肝炎患者受益于这两种疾病的抗病毒治疗的巨大进步，不幸的是，由于缺乏对这种最具侵袭性的病毒性肝炎的有效治疗，HDV仍然是一个巨大的未满足的医疗需求。 Eiger肝脏和传染病发展高级副总裁Eduardo Martins博士说：在许多国家，HDV呈现出真正的公共卫生挑战。 “我们期待扩大我们的HDV开发计划，包括Lambda单一疗法和潜在的组合，包括lonafarnib。”

关于LIMT HDV第二阶段研究
LIMT HDV是约30-40例慢性HDV患者每周一次施用Lambda 120或180微克皮下注射的1：1随机，开放标签研究，持续48周。随后的治疗结束后将进行无治疗的24周观察期。第二阶段研究的主要目标是评估两种剂量水平的Lambda单一疗法治疗慢性HDV感染患者的安全性，耐受性和疗效。所有患者在整个研究中也将给予抗乙型肝炎病毒核心（t）ide类似物。 LIMT HDV是一项国际研究，目前在新西兰，以色列和巴基斯坦的网站上招收。

关于聚乙二醇化干扰素λ1a
聚乙二醇化干扰素λ1a（“Lambda”）是一种经过良好表征的晚期第一类III类干扰素（IFN），其刺激在病毒感染期间发展宿主保护的关键的免疫应答。 λ靶向与IFNα所靶向的I型IFN受体不同的III型IFN受体。这些III型受体在造血和中枢神经系统细胞表达有限的肝细胞上高度表达，这可能减少与其他IFN相关的脱靶作用并提高Lambda的耐受性。尽管Lambda不使用IFNα受体，但通过IFNα或IFNα受体复合物的信号传导导致相同的Jak-STAT信号转导级联的激活。

Eiger于2016年4月向Bristol-Myers Squibb授予Lambda全球权力.Lambda已经在涉及3000多名受试者的HBV / HCV临床试验中进行了管理。 Lambda尚未被批准用于任何指示。
关于甲型肝炎病毒（HDV）
甲型肝炎（或丙型肝炎）是由HDV感染引起的，被认为是人类中最严重的病毒性肝炎形式之一。乙型肝炎病毒只发生在携带乙型肝炎病毒（HBV）的个体中的共感染。乙型肝炎导致比单独的HBV更严重的肝脏疾病，并且与肝纤维化加快，肝癌和肝衰竭有关。三角洲是一种对全球健康有重大影响的疾病，可能会影响全球约一千五百到二百万人。 HDV的流行在世界各地不同。据报道，全球HDV感染约占慢性乙型肝炎携带者的4.3％〜5.7％。在某些地区，包括蒙古，中国，俄罗斯，中亚，巴基斯坦，土耳其，非洲和南美洲的某些地区，感染慢性HBV的患者的HDV患病率甚至更高，HDV患病率高达60％在蒙古和巴基斯坦的HBV感染患者中报道。