Delving into the Latest Updates on Seraprevir with Synapse

To explore the efficacy of the combination of selaprevir potassium tablets and sofosbuvir tablets in the treatment of adult patients with non-cirrhotic chronic hepatitis C with genotypes 2, 3, and 6; To preliminarily evaluate the safety of the combined treatment regimen of selaprevir potassium 200 mg bid and sofosbuvir 400 mg qd

Start Date22 Apr 2019

Sponsor / Collaborator

Ginkgo Pharmaceutical (Suzhou) Co., Ltd.

NCT04111367

/ Unknown statusPhase 2

A Phase IIa, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Seraprevir in Combination With Sofosbuvir in Patients With Chronic Genotype 2,3,6 Hepatitis C Virus Infection

This study was to assess the safety and efficacy of Seraprevir in combination with sofosbuvir in patients with Hepatitis C (HCV) genotype2,3,6. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12).

Start Date03 Apr 2019

Sponsor / Collaborator

Ginkgo Pharmaceutical (Suzhou) Co., Ltd.

CTR20182134

/ CompletedPhase 3

评价赛拉瑞韦钾片联合索磷布韦片治疗1型慢性丙型肝炎患者的有效性与安全性的多中心、单臂、开放的III期临床研究

[Translation] A multicenter, single-arm, open-label phase III clinical study to evaluate the efficacy and safety of selaprevir potassium tablets combined with sofosbuvir tablets in the treatment of patients with chronic hepatitis C type 1

评价丙肝蛋白酶抑制剂赛拉瑞韦钾片联合丙肝复制酶抑制剂索磷布韦片的固定剂量组合方案治疗基因1型成人非肝硬化慢性丙型肝炎患者的有效性与安全性

[Translation]

To evaluate the efficacy and safety of a fixed-dose combination of the hepatitis C protease inhibitor celazrevir potassium tablets and the hepatitis C replicase inhibitor sofosbuvir tablets in the treatment of adult non-cirrhotic chronic hepatitis C genotype 1 patients

Start Date17 Oct 2018

Sponsor / Collaborator

Ginkgo Pharmaceutical (Suzhou) Co., Ltd.

100 Clinical Results associated with Seraprevir

Login to view more data

100 Translational Medicine associated with Seraprevir

Login to view more data

100 Patents (Medical) associated with Seraprevir

Login to view more data

3

Literatures (Medical) associated with Seraprevir

01 Sep 2021·Journal of Gastroenterology and HepatologyQ3 · MEDICINE

Seraprevir and sofosbuvir for treatment of chronic hepatitis C virus infection: A single‐arm, open‐label, phase 3 trial

Q3 · MEDICINE

Article

Author: Lin, Shide ; Huang, Chengyu ; Zhu, Qingjing ; Lin, Jianmei ; Li, Xiaowen ; Wang, Xiaozhong ; Niu, Junqi ; Yan, Xuebing ; Li, Guangming ; Zhang, Yuexin ; Chen, Li ; Wu, Xuegang ; Xin, Yongning ; Wei, Wei ; Zheng, Sujun ; Liu, Quan ; Zhang, Liaoyun ; Ning, Qin ; Niu, Duan ; Jia, Jidong ; Wang, Zheng ; Wang, Li ; Tong, Lixin ; Tong, Zhaowei ; Wu, Guicheng ; Su, Minghua ; Kong, Fei ; Wang, Jing ; Xing, Huichun ; Wen, Xiaoyu ; Wen, Xiaofeng

AbstractBackground and AimThis single‐arm, open‐label, multicenter, phase 3 trial evaluated the efficacy and safety of seraprevir, an hepatitis C virus (HCV) nonstructural protein 3/4A (NS3/4A) inhibitor, combined with sofosbuvir for treating Chinese patients with chronic HCV infection without cirrhosis.MethodsTreatment‐naive or interferon‐experienced adult patients without cirrhosis were treated with a universal, combinational regimen of seraprevir 100 mg, twice daily and sofosbuvir 400 mg, once daily, for 12 or 24 weeks. The primary efficacy endpoint was sustained virologic response at week 12 after treatment (SVR12).ResultsOverall, 205 patients with genotype 1 HCV infection without cirrhosis were enrolled from 23 sites, 202 of whom completed the full treatment and post‐treatment course and 3 discontinued follow‐up. In total, 27 patients (13.2%) were interferon experienced. SVR12 was achieved by 201 out of 205 (98.0% [95% CI, 95.1%, 99.5%]) patients, 100.0% of patients with genotype 1a, and 98.0% of genotype 1b. In the other exploratory study, SVR 12 was achieved by 100% patients with genotype 2 (n = 21), genotype 3 (n = 7), and genotype 6 (n = 8). The majority of adverse events were mild to moderate and transient and did not require a specific medical intervention.ConclusionsThe all‐oral, ribavirin‐free regimen of seraprevir and sofosbuvir is an effective and well‐tolerated treatment option for Chinese patients mono‐infected with HCV, including those with a history of interferon treatment.

01 Nov 2018·Acta Pharmacologica Sinica

GP205, a new hepatitis C virus NS3/4A protease inhibitor, displays higher metabolic stability in vitro and drug exposure in vivo

Article

Author: Zhang, Lin-Qi ; Qing, Jie ; Ma, Lan ; Li, Ben ; Chen, Li ; Zhai, Pei-Bin

NS3/4A serine protease is a prime target for direct-acting antiviral therapies against hepatitis C virus (HCV) infection. Several NS3/4A inhibitors have been widely used in clinic, while new inhibitors with better characteristics are still urgently needed. GP205 is a new macrocyclic inhibitor of NS3/4A with low nanomolar activities against HCV replicons of genotypes 1b, 2a, 4a, and 5a, with EC₅₀ values ranging from 1.5 to 12.8 nmol/L. In resistance selection study in vitro, we found resistance-associated substitutions on D168: The activity of GP205 was significantly attenuated against 1b replicon with D168V or D168A mutation, similar as simeprevir. No cross resistance of GP205 with NS5B or NS5A inhibitor was observed. Combination of GP205 with sofosbuvir or daclatasvir displayed additive or synergistic efficacy. The pharmacokinetic profile of GP205 was characterized in rats and dogs after oral administration, which revealed good drug exposure both in plasma and in liver and long plasma half-life. The in vitro stability test showed ideal microsomal and hepatic cells stability of GP205. The preclinical profiles of GP205 support further research on this NS3/4A inhibitor to expand the existing HCV infection therapies.

MoleculesQ3 · CHEMISTRY

LC-ESI-MS/MS Analysis and Pharmacokinetics of GP205, an Innovative Potent Macrocyclic Inhibitor of Hepatitis C Virus NS3/4A Protease in Rats

Q3 · CHEMISTRY

ArticleOA

Author: Sun, Qiushi ; Wang, Xiuyun ; Yang, Nan ; Fan, Guorong ; Zhao, Xin ; Xu, Zihua ; Cao, Yuqing ; Chen, Li

A high-throughput, sensitive and specific LC-ESI-MS/MS method was established for the quantitative determination of GP205, a potent inhibitor of hepatitis C virus NS3/4A protease, in rat. The analyte was isolated from 25 μL plasma sample by 96-well LLE. Good linearity was achieved within the concentration range of 2–5000 ng/mL (r2 > 0.996). The intra- and inter-day precision was less than 10%. The accuracy ranged from 0.8% to 5.5% for GP205 in quality control samples at three levels. GP205 was stable during the analysis and the storage period. The method was successfully applied to pharmacokinetic studies of GP205 in Sprague-Dawley rats. The pharmacokinetic profiles of GP205 at three dose levels with oral administration and one dose level with intravenous administration were successfully studied for the first time in SD rats, respectively. After single oral administration of GP205 at the doses of 2.5, 5, 10 mg/kg, respectively, Cmax and AUC0-τ were proportional to the doses given. The absolute bioavailability was estimated as 34% based on the AUCs of oral administration at the dose of 5 mg/kg and intravenous administration at the dose of 1 mg/kg. The data presented in this study provides useful information for further study for GP205.

100 Deals associated with Seraprevir

Login to view more data

R&D Status

10 top R&D records.

Login

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis C	Phase 3	China	The First Hospital of Jilin University	-
Hepatitis C	Phase 3	China	The Naval Medical University of PLA	-
Chronic hepatitis C genotype 1	Preclinical	China	Ginkgo Pharmaceutical (Suzhou) Co., Ltd.	17 Oct 2018

Login to view more data

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04001608 (Pubmed \| J Gastroenterol Hepatol) Manual	Phase 3	Hepatitis C	205	sofosbuvir+seraprevir	(etlmnfewfs) = twtcxqemod assxjyqwhd (wqkteepayj, 95.1 - 99.5)	Positive	01 Sep 2021
2017L00637 (EASL2020)	Phase 3	Chronic hepatitis C genotype 1	205	Sofosbuvir	qncpbxideh(dajxbozccf) = aypbhhrmlt yxqdfidnky (hzjclnqnnd ) View more	Positive	27 Aug 2020
2017L00637 (EASL2020)	Phase 3	Chronic hepatitis C genotype 1	205	Seraprevir	qncpbxideh(dajxbozccf) = zapeezvexv yxqdfidnky (hzjclnqnnd ) View more	Positive	27 Aug 2020