Eiger获得了HDV治疗的FDA突破性治疗指定

StephenW

Eiger receives FDA breakthrough therapy designation for HDV therapy
December 18, 2018

Eiger BioPharmaceuticals received FDA breakthrough therapy designation for lonafarnib, a prenylation inhibitor designed to treat hepatitis D, according to a press release.

“There is an urgent medical need to treat HDV, the most serious form of viral hepatitis,” David Apelian, MD, PhD, chief operating officer and executive medical officer at Eiger BioPharmaceuticals, said in the release. “We look forward to collaborating with the FDA as we accelerate development of lonafarnib for HDV infection.”


The new FDA designation follows positive phase 2 clinical study data. During the phase 2 study, patients achieved an HDV RNA decline of 2 log 10 or higher and alanine aminotransferase normalization.

Lonafarnib is currently under investigation in a randomized control phase 3 study including 300 patients and 100 controls. The primary endpoint is an HDV RNA decline of 2 log 10 or higher and ALT normalization at the end of 48 weeks.

“The Phase 3 D-LIVR Study is the first-ever, global registration trial in HDV, with the potential to bring two separate, lonafarnib-based treatment regimens to HDV patients,” Apelian added in the release.

Reference: www.eigerbio.com

StephenW

Eiger获得了HDV治疗的FDA突破性治疗指定
2018年12月18日

根据一份新闻稿，Eiger BioPharmaceuticals获得了FDA的突破性治疗名称lonafarnib，一种用于治疗丁型肝炎的异戊二烯化抑制剂。

Eiger BioPharmaceuticals首席运营官兼执行医疗官David Apelian博士在发布会上说：“治疗HDV是一种迫切的医疗需求，HDV是最严重的病毒性肝炎。” “我们期待与FDA合作，因为我们加速了lonafarnib对HDV感染的开发。”


新的FDA名称遵循正面的2期临床研究数据。在第2阶段研究期间，患者实现HD log RNA下降2log 10或更高并且丙氨酸氨基转移酶正常化。

Lonafarnib目前正在一项随机对照3期研究中接受调查，该研究包括300名患者和100名对照。主要终点是HDV RNA下降2 log 10或更高，48周末ALT正常化。

“第3阶段D-LIVR研究是有史以来第一次在HDV进行的全球注册试验，有可能为HDV患者带来两种独立的，基于lonafarnib的治疗方案，”Apelian在发布中补充说。

参考：www.eigerbio.com