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Hepatitis C virus protease inhibitor, Furaprevir


Research & Development

Furaprevir is a novel inhibitor of Hepatitis C virus (HCV) NS3/4A protease. This protease is essential for HCV replication and inhibitors have been shown to be effective in reducing viral load. TaiGen’s goal is to develop a highly effective and affordable combination regimen with Furaprevir as the anchor. Furaprevir possesses the following unique characteristics that differentiate it from the competitors:

Active in all six HCV genotypes.

Active against protease mutants selected by the other protease inhibitors.


Clinical Development

In October 2016, TaiGen signed an agreement with YiChang HEC ChangJiang Pharmaceutical Co., Ltd ("HEC") to establish a joint venture in mainland China for the joint development, manufacturing, and commercialization of direct-acting antiviral agents (DAAs) for HCV infection in the Greater China region.

The joint venture, Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd, was established in January 2017 .

The combination of Furaprevir (NS3/4A protease inhibitor)+HEC Yimitasvir (NS5A inhibitor) has already completed China Phase II treatment in 2018,anticipate to initiate phase III by 2019.


Awards and Grants

Received grants from the Taiwan Ministry of Economic Affairs for preclinical, Phase 1 and clinical development.

99 patents were filed worldwide including EU, US, Taiwan, China, Japan, South Africa, Australia, and New Zealand

2015 National Innovation Award from Taiwan’s Institute for Biotechnology and Medicine Industry (IMBI)

2015 Bronze Award for New Drug R&D, TFDA & Ministry of Economic Affairs

2016 Medal of Technology Award from China Chemical Society

2017 The Innovation of the Year from the Taiwan Bio Industry Organization

2017 Bronze Award for Pharmaceutical Technology Research & Development Award, from TFDA & Ministry of Economic Affairs


Intellectual Property

Patents were filed worldwide to protect composition of matter and use up to 2030.


Presentations


APASL STC 2018

A Randomized, Doubled-blinded, Placebo-controlled, Dose-escalated Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Furaprevir in Healthy Chinese Volunteers. Xiao-Min Li, Su-Mei Xu, Cheng-Yuan Tsai, Li-Wen Chang, Ping-Sheng Xu.

Furaprevir/ Yimitasvir for Treatment-naïve Chinese Patients with Genotype 1 HCV: an On-going, Open-label, Phase II Study. Jun Quan, Xin-Yue Chen, You-Wen Tan, Yue-Min Nan, Jia Shang, Chih-Ming Chen, Li-Wen Chang, Lai Wei.

Two Novel Hepatitis C Virus Antivirals, Furaprevir and Yimitasvir in Healthy Chinese Volunteers: A Drug-Drug Interaction Study. Su-Min Xu, Xiao-Min Li, Cheng-Yuan Tsai, Xing-An Wang, Li-Wen Chang, Ping-Sheng Xu

Combination of Furaprevir and Yimitasvir Demonstrated Synergistic Antiviral Effects without Interaction in vivo. Cheng-Yuan Tsai, Yi-Fen Chen, Chih-Ming Chen, Xinan Wang, Yingjun Zhan, Philip Huang, Ming-Chu Hsu.


APASL STC 2016

Over 3 Logs of Reductions in HCV RNA in GT-1/2/4/6 Subjects with 3 Doses of TG-2349. Shih-Jer Hsu, Chau-Ting Yeh, Tarek Hassanein, Suzanne Kim, Tsung-Hui Hu, Chun-Jen Liu, Chen-En Tsai, Chih-Ming Chen, Li-Wen Chang, Chu-Chung Lin, Chi-Hsin R. King, Ming-Chu Hsu.

RVR of 92% Achieved by 12 Weeks of TG-2349 Plus PEGIFN/RBV in GT-1b Subjects. Ming-Lung Yu, Shih-Jer Hsu, Chau-Ting Yeh, Chao-Hung Hung, Chih-Lang Lin, Ming-Yao Chen, Pei-Jer Chen, Yi-Hsiang Huang, Pin-Nan Cheng, Chih-Ming Chen, Edward Kuo, Li-Wen Chang, Chu-Chung Lin, Chi-Hsin R. King, Ming-Chu Hsu.

Rapid antiviral response with TG-2349 plus PegIFN-RBV in naïve GT-1b subject: an interim analysis. Ming-Lung Yu, Shih-Jer Hsu, Chau-Ting Yeh, Ming-Yao Chen, Pei-Jer Chen, Yi-Hsiang Huang, Pin-Nan Cheng, Tsung-Hui Hu, Chih-Ming Chen, Li-Wen Chang, Chu-Chung Lin, Felice Sheen, Chi-Hsin R. King, Ming-Chu Hsu.

TG-2349 three-day monotherapy with significant antiviral activity in Caucasian and East Asian HCV Subjects. Chau-Ting Yeh, Tarek Hassanein, Suzanne Kim, Shih-Jer Hsu, Tsung-Hui Hu, Chun-Jen Liu, Chen-En Tsai, Chih-Ming Chen, Li-Wen Chang, Chu-Chung Lin, Chi-Hsin R. King, Ming-Chu Hsu.


EASL 2016

Higher genetic barrier revealed in HCV GT-1b/2/4/6 subjects than GT-1a patients – a proof of concept trial of TG-2349 (Furaprevir). Chau-Ting Yeh, Tarek Hassanein, Suzanne Kim, Shih-Jer Hsu, Tsung-Hui Hu, Chun-Jen Liu, Chen-En Tsai, Chih-Ming Chen, Li-Wen Chang, Chu-Chung Lin, Chi-Hsin R. King, Ming-Chu Hsu.

TG-2349, a potent protease inhibitor, plus PegIFN/RBV provides excellent virological responses for harder-to-treat subpopulations of HCV-1b non-cirrhotic patients. Ming-Lung Yu, Shih-Jer Hsu, Chau-Ting Yeh, Chao-Hung Hung, Ming-Yao Chen, Pei-Jer Chen, Yi-Hsiang Huang, Pin-Nan Cheng, Chih-Ming Chen, Li-Wen Chang, Chu-Chung Lin, Felice Sheen, Chi-Hsin R. King, Edward Kuo, Ming-Chu Hsu.


AASLD 2014

The Antiviral Profile of TG-2349, a novel HCV Protease Inhibitor with Pan-Genotypic Activity Chih-Ming Chen, Yi-Fen Chen, Chu-Chung Lin, Chi-Hsin R. King, Ming-Chu Hsu.

Evaluation of TG‐2349, a Novel HCV Protease Inhibitor with Pan‐Genotypic Activity, in Replicon‐Mouse Models with Luciferase. Ying‐Huey Huang, Chih‐Ming Chen, Hung‐Ming Hsu, Chu‐Chung Lin, Chi‐HsinR. King, and Ming‐Chu Hsu.


AIMECS 2013

Design and Discovery of Potent and Pan-genotypic HCV NS3/4A Protease Inhibitors. Chu-Chung Lin, Chen-Fu Liu, Kuang-Yuan Lee, Pei-Chin Cheng, Yo-Chin Liu, Pin Lo, Hung-Chuan Chen, Chih-Ming Chen, Richard King, and Ming-Chu Hsu.

TG-2349, a Novel HCV Protease Inhibitor with Pan-genotypic Activity. Chih-Ming Chen, Hsiao-Chao Chien, Chia-Hui Wang, Yi-Fen Chen, Chen-Fu Liu, Chu-Chung Lin, Richard King, and Ming-Chu Hsu.

TG-2349, a potent HCV NS3/4A protease inhibitor, showed in vivo efficacy in mice. Ying-Huey Huang, Hsiao-Wen Lin, Chu-Chung Lin, Chi-Ming Chen, Chi-Hsin R. King, Ming-Chu Hsu.


AASLD 2013

A Phase I/IIa Study of Safety, Tolerability, and Pharmacokinetic Profiles of TG-2349, a Pan-Genotypic HCV Protease Inhibitor, in Healthy East Asian and Caucasian Subjects, and its Antiviral Activity in Chronic Hepatitis C Patients Chen-En Tsai, Li-Wen Chang, Yu-Ting Chang, Chiung-Yuan Hsu, Chih-Ming Chen, Cheng-Yuan Tsai, Chu-Chung Lin, Chi-Hsin R. King, Chun-Jen Liu, Ding-Shinn Chen, Ming-Chu Hsu.