[Translation] A randomized, open-label, single-dose, two-period, double-crossover, fasting bioequivalence study of entecavir tablets provided by Zhejiang Qizheng Pharmaceutical Co., Ltd. and entecavir tablets (trade name: Boluding®) from Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd. in healthy Chinese subjects

以浙江麒正药业有限公司提供的恩替卡韦片（规格：0.5 mg）为受试制剂，以持证商为中美上海施贵宝制药有限公司的恩替卡韦片（商品名：博路定®，规格：0.5 mg）为参比制剂，考察两制剂在空腹状态下单次给药的药代动力学参数及相对生物利用度，评价两制剂是否具有生物等效性；同时评价两种制剂在健康人体中的安全性和耐受性。

[Translation]

Entecavir tablets (specification: 0.5 mg) provided by Zhejiang Qizheng Pharmaceutical Co., Ltd. were used as the test preparation, and entecavir tablets (trade name: Boludin®, specification: 0.5 mg) produced by Shanghai Bristol-Myers Squibb Pharmaceuticals Co., Ltd. were used as the reference preparation. The pharmacokinetic parameters and relative bioavailability of the two preparations after a single dose in the fasting state were investigated to evaluate whether the two preparations were bioequivalent; at the same time, the safety and tolerability of the two preparations in healthy humans were evaluated.

Start Date16 Apr 2024

Sponsor / Collaborator

Zhejiang Qizheng Pharmaceutical Co., Ltd

CTR20240626 / RecruitingPhase 2

评估 TQA3810 片联合/不联合核苷（酸）类似物在初治/经治慢性乙型肝炎患者中的疗效和安全性的随机、双盲、安慰剂对照的 IIa 期临床试验

[Translation] A randomized, double-blind, placebo-controlled Phase IIa clinical trial to evaluate the efficacy and safety of TQA3810 tablets with or without nucleoside (acid) analogs in treatment-naive or treatment-experienced chronic hepatitis B patients

主要目的：评价 TQA3810 片联合/不联合口服核苷（酸）类药物在初治/经治慢乙肝患者中的安全性和耐受性；次要目的评价 TQA3810 片联合/不联合口服核苷（酸）类药物在初治/经治慢乙肝患者中的疗效；评价 TQA3810 片联合/不联合口服核苷（酸）类药物在初治/经治慢乙肝患者中的药代动力学（PK）特征；评价 TQA3810 片联合/不联合口服核苷（酸）类药物在初治/经治慢乙肝患者中的药效学（PD）特征；评价 TQA3810 在初治/经治慢乙肝患者中的血药浓度-QT 间期定量分析（C-QT）研究；

[Translation]

Primary objective: To evaluate the safety and tolerability of TQA3810 tablets combined with/without oral nucleosides (acids) in patients with chronic hepatitis B who have been treated for the first time/after treatment. Secondary objective To evaluate the efficacy of TQA3810 tablets combined with/without oral nucleosides (acids) in patients with chronic hepatitis B who have been treated for the first time/after treatment. To evaluate the pharmacokinetic (PK) characteristics of TQA3810 tablets combined with/without oral nucleosides (acids) in patients with chronic hepatitis B who have been treated for the first time/after treatment. To evaluate the pharmacodynamic (PD) characteristics of TQA3810 tablets combined with/without oral nucleosides (acids) in patients with chronic hepatitis B who have been treated for the first time/after treatment. To evaluate the blood drug concentration-QT interval quantitative analysis (C-QT) study of TQA3810 in patients with chronic hepatitis B who have been treated for the first time/after treatment.

Start Date13 Mar 2024

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

NCT06150014 / RecruitingPhase 1/2

Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets Monotherapy or in Combination With Nucleoside (Acid) Analogues in Treatment-naïve Patients and Treated Patients With Chronic Hepatitis B

This is a randomized, double-blind Phase Ib/IIa multicenter trial. All eligible subjects will receive TQA3605 tablets or placebo in combination with nucleoside (acid) analogues. A total of 64 subjects will be enrolled.

Start Date07 Dec 2023

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Entecavir

100 Translational Medicine associated with Entecavir

100 Patents (Medical) associated with Entecavir

3,017

Literatures (Medical) associated with Entecavir

19 Mar 2024·Journal of virology

Correction for Nakajima et al., “Biochemical and Structural Properties of Entecavir-Resistant Hepatitis B Virus Polymerase with L180M/M204V Mutations”

Article

Author: Toyoda, Tetsuya ; Wakita, Takaji ; Hattori, Shin-Ichiro ; Mitsuya, Hiroaki ; Yasutake, Yoshiaki ; Nakajima, Shogo ; Muramatsu, Masamichi ; Watashi, Koichi ; Kato, Takanobu ; Tamura, Noriko ; Maeda, Kenji

01 Feb 2024·Alimentary pharmacology & therapeutics

Longitudinal changes in renal function in patients with chronic hepatitis B on antiviral treatment

Article

Author: Lee, Danbi ; Choi, Jonggi ; Choi, Won-Mook ; Shim, Ju Hyun ; Kim, Kang Mo ; Cho, Minjoo ; Hong, Hyeyeon ; Lee, Han Chu ; Lim, Young-Suk ; Lim, Chaeyeon

Summary:

Background:

Patients with chronic hepatitis B (CHB) on nucleos(t)ide analogues (NUCs) often experience renal function decline. Conflicting results regarding the impact of NUC use and renal function have recently been reported.

Aim:

To examine longitudinal changes in renal function according to the NUC treatment type compared with untreated patients

Methods:

From 2014 to 2022, we retrospectively analysed 10,642 patients with CHB. The primary outcome was chronic kidney disease (CKD) progression, which was defined as a minimum one‐stage elevation. We applied propensity score (PS) matching for outcome comparisons.

Results:

In the PS‐matched cohort of 1996 pairs, the NUC‐treated group (7.6/100 person‐years [PYs]) had a significantly higher CKD progression risk than the untreated group (4.4/100 PYs), with a hazard ratio (HR) of 1.70 (p < 0.001). The tenofovir disoproxil fumarate (TDF)‐treated group (7.9/100 PYs) showed a 1.76‐fold increased CKD progression risk compared with the untreated group (4.5/100 PYs) in the PS‐matched cohort (p < 0.001). Both the entecavir‐ and tenofovir alafenamide (TAF)‐treated groups showed CKD progression risks comparable to those of the untreated group in the PS‐matched cohorts of 755 and 426 pairs, respectively (p = 0.132 and p = 0.120, respectively). No significant CKD progression risk was found between the entecavir‐ (6.0/100 PYs) and TAF‐treated (5.2/100 PYs) groups in the PS‐matched cohort of 510 pairs (p = 0.118).

Conclusions:

NUC‐treated patients, especially those on TDF, faced a higher CKD progression risk than untreated patients. Entecavir‐ and TAF‐treated patients had comparable CKD progression risks to untreated patients. No difference was observed between entecavir and TAF in the risk of CKD progression.

Hepatology research : the official journal of the Japan Society of Hepatology

Risk of hepatocellular carcinoma after curative treatment when switching from tenofovir disoproxil fumarate or entecavir to tenofovir alafenamide: A real‐world multicenter cohort study

Article

Author: Lee, Yun Bin ; Shin, Hyunjae ; Park, Youngsu ; Yoon, Jung-Hwan ; Kim, Yoon Jun ; Sinn, Dong Hyun ; Ko, Yunmi ; Cho, Eun Ju ; Song, Byeong Geun ; Kim, Seung Up ; Lee, Jeong-Hoon ; Park, Jeayeon ; Yu, Su Jong ; Hur, Moon Haeng

Abstract:

Aim:

Antiviral treatment reduces the risk of developing hepatocellular carcinoma (HCC) in patients with chronic hepatitis B. However, there is a lack of high‐quality evidence regarding the preventive effects of tenofovir alafenamide (TAF) on HCC. We evaluated the impact of TAF use after curative treatment on HCC recurrence.

Methods:

Patients who underwent surgery or radiofrequency ablation as a curative treatment for HCC were selected. Those patients who continued antiviral treatment with nucleos(t)ide analogs (NAs; entecavir [ETV] or tenofovir disoproxil fumarate [TDF]) or switched to TAF were included. The primary outcome was HCC recurrence, and the time‐varying effect of NA use on HCC recurrence was analyzed using various statistical methods.

Results:

Among 2794 consecutive patients with chronic hepatitis B who received curative treatment for HCC, 199 subsequently switched from ETV or TDF to TAF. After a median of 3.0 years, 1303 patients (46.6%) experienced HCC recurrence. After propensity score matching (ratio 1:10), switching to TAF was not associated with an increased HCC recurrence (HR 1.00, 95% CI 0.68–1.47; p = 1.00) by time‐varying Cox analysis. Switching to TAF was not associated with HCC recurrence in subgroups of NA (HR 1.06, 95% CI 0.67–1.67; p = 0.81 for TDF, and HR 1.09, 95% CI 0.51–2.33; p = 0.82 for ETV). Kaplan–Meier analysis showed comparable HCC recurrence‐free survival between patients who switched to TAF and those who continued with their NA (p = 0.08). Time‐varying Cox analyses in various subgroups confirmed the primary findings.

Conclusions:

TAF is as effective as TDF and ETV in preventing HCC recurrence after curative treatment.

News (Medical) associated with Entecavir

18 Jun 2024

·www.globenewswire.com

Gyre Therapeutics Announces Publication in Journal of Gastroenterology and Hepatology

SAN DIEGO, June 18, 2024 (GLOBE NEWSWIRE) -- Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), a clinical-stage, self-sustainable biotechnology company developing anti-fibrotic therapeutics for a variety of chronic organ diseases, today announced the publication of the manuscript titled “Hydronidone induces apoptosis in activated hepatic stellate cells through endoplasmic reticulum stress-associated mitochondrial apoptotic pathway” in the Journal of Gastroenterology and Hepatology. This publication includes both in vivo and in vitro studies supporting the potential of hydronidone (F351), a novel derivate of pirfenidone, as a promising therapy for the treatment of liver fibrosis. “Preclinical animal studies have shown that treatment with hydronidone attenuated liver fibrosis by inhibiting the activation of hepatic stellate cells (HSCs), although the underlying mechanisms of action are still not fully understood,” said Han Ying, Ph.D., CEO of Gyre. “The findings of these in vivo and in vitro studies demonstrate that hydronidone induces apoptosis in activated HSCs (aHSCs) via the endoplasmic reticulum stress (ERS)-associated mitochondrial apoptotic pathway and suggest that hydronidone may contribute to the improvement of liver fibrosis. These findings further enhance our understanding of hydronidone and underscore its therapeutic potential in treating liver fibrosis.” Liver fibrosis is characterized by the progressive accumulation of extracellular matrix (ECM), which disrupts the normal liver architecture. Research has shown that quiescent HSCs undergo activation and transform into myofibroblast-like cells to produce ECM in chronic liver disease, and therefore that liver fibrosis can be reversed by eliminating aHSCs. This study found that treatment with hydronidone significantly promoted apoptosis in aHSCs in both the CCl4- and DDC-induced liver fibrosis in mice and LX-2 cells. Mechanistic studies revealed that hydronidone triggered ERS and subsequently activated the IRE1α-ASK1-JNK pathway and subsequent dysfunction of the mitochondria, ultimately resulting in the apoptosis of aHSCs. Gyre Pharmaceuticals, Gyre’s majority indirectly owned subsidiary in the People's Republic of China (PRC), is currently evaluating hydronidone in a Phase 3 trial for the treatment of Chronic Hepatitis B (CHB)-associated liver fibrosis in the PRC with topline data anticipated by early 2025. The trial is evaluating 248 patients with a primary endpoint of the reduction of the liver fibrosis score (Ishak Scoring System) by at least one grade after taking hydronidone in combination with entecavir. Pending results from the Phase 3 trial, Gyre intends to initiate a Phase 2a proof-of-concept trial to evaluate hydronidone for the treatment of NASH-associated liver fibrosis in 2025. About Gyre Therapeutics Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of NASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in NASH is based on the company’s experience in NASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts and timing of expected clinical readouts, including timing of topline data from Gyre Pharmaceuticals’ Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC and initiation of Gyre’s Phase 2a trial in the U.S. for F351. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2023 filed on March 27, 2024 and in other filings with the Securities and Exchange Commission. Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law. For Investors:Stephen Jasperstephen@gilmartinir.com

Phase 2Phase 3

05 Jun 2024

·www.biospace.com

Aligos Therapeutics Presents Positive Data at the EASL Congress 2024

SOUTH SAN FRANCISCO, Calif., June 05, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced positive data from six poster presentations at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy. The clinical poster presentations highlight the continued potent antiviral activity of ALG-000184 for chronic hepatitis B (CHB) in both HBeAg-positive and HBeAg-negative subjects. Data from ≤72 weeks following an oral daily dose of 300 mg ALG-000184 monotherapy demonstrated sustained HBV DNA suppression (<LLOQ <10 IU/mL) in 9/10 (90%) HBeAg-positive CHB subjects with no viral breakthrough. New data also showed that as HBeAg declined to near negativity in this patient population, anti-HBe antibody (HBeAb) levels exhibited a positive trend. Reported for the first time were antiviral and safety data in HBeAg-negative CHB subjects who received a daily single dose of 300 mg ALG-000184 monotherapy for ≤60 weeks. In all 11 subjects (100%), complete suppression of HBV DNA (<LLOQ 10 IU/mL) and RNA (<LLOQ 10 copies/mL) were noted, with reduction in HBcrAg levels indicating inhibition of HBV replication, as well as inhibition of cccDNA establishment/replenishment. In both patient populations, ALG-000184 continues to be well tolerated with no viral breakthrough. “We designed ALG-000184 as a highly potent agent that could deliver broad antiviral efficacy in hepatitis B patients, regardless of their HBeAg status,” stated Lawrence Blatt, PhD, MBA, Chairman, President & CEO of Aligos Therapeutics. “These new data in HBeAg-negative CHB patients complement the broad antiviral activity we have already reported in HBeAg-positive CHB patients, with data now up to 72 weeks showing 90% of subjects achieved HBV DNA suppression. The extent of HBV DNA suppression observed to date in both CHB patient populations appear to exceed those reported by the current standard of care nucleos(t)ides, leading us to believe this is a best/first-in-class molecule.” Additionally, other preclinical poster presentations demonstrate the potential of next generation siRNAs for treating metabolic dysfunction-associated steatohepatitis (MASH) and CHB as well as a novel CAM-A molecule for the treatment of CHB. Details of the presentations are as follows: ALG-000184: Potential best-in-class small molecule CAM-E for chronic hepatitis B (CHB) Title: Extended Treatment of HBeAg+ CHB Subjects with the Capsid Assembly Modulator ALG-000184 with or without Entecavir is Associated with Reductions in Viral Markers and Favorable Anti-HBeAb trends Presenter: Professor Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair and Chief of the Division of Gastroenterology and Hepatology, University of Hong Kong Date/Time: June 5, 2024 at 8:30am CEST Title: Dosing with the Capsid Assembly Modulator ALG-000184 in Untreated HBeAg Negative CHB Subjects Results in Potent Antiviral Effects Including Suppression of HBV DNA/RNA and Declines in HBcrAg Levels Presenter: Kosh Agarwal, MBBS, MRCP (UK), MD, FRCP (Ed), FRCP (London), Consultant Hepatologist and Transplant Physician, Institute of Liver Studies, King’s College Hospital NHS Foundation Trust Time: June 5, 2024 at 8:30am CEST Title: Association of baseline characteristics and plasma ALG-001075 to HBsAg responses in HBeAg+ CHB subjects following ALG-000184±ETV treatment Presenter: Kha Le, PhD Time: June 5, 2024 at 8:30am CEST Preclinical Title: In vitro and in vivo pharmacological characterization of human PNPLA3-targeting short interfering RNA molecules for the treatment of metabolic dysfunction-associated steatohepatitis Presenter: Jieun Song, PhD Time: June 6, 2024 at 8:30am CEST Title: Second generation HBV siRNAs with novel chemistries demonstrate improved profiles compared with ALG-125755 and other clinical stage siRNAs Presenter: Jin Hong, PhD Date/Time: June 8, 2024 at 8:30am CEST Title: Non-HAP CAM-A ALG-006746 and ALG-006780 induce rapid HBsAg reductions in AAV-HBV mice and have favorable pharmacokinetic profiles Presenter: Yannick Debing, PhD Date/Time: June 8, 2024 at 8:30am CEST The presentations can be found on the Scientific Presentations & Conferences section of the Aligos website ( ) after the live event. About Aligos Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements”, including without limitation, statements regarding Aligos’ financial results and performance as well as research and development activities, including regulatory status and the timing of announcements and updates relating to our regulatory filings and clinical trials. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2024 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. Investor Contact Jordyn Tarazi Vice President, Investor Relations & Corporate Communications +1 (650) 910-0427 jtarazi@aligos.com Media Contact Michael Fitzhugh LifeSci Communications mfitzhugh@lifescicomms.com

Clinical Result

22 May 2024

·www.globenewswire.com

Aligos Therapeutics Announces Six Abstracts Accepted for Presentation at EASL 2024

SOUTH SAN FRANCISCO, Calif., May 22, 2024 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, today announced six abstracts have been accepted for poster presentations, including two Top abstracts, at the European Association for the Study of the Liver (EASL) Congress 2024, being held June 5-8 in Milan, Italy. The abstracts released today can be found on the EASL website at www.easlcongress.eu. Details from the abstracts released today are as follows: ALG-000184: Potential best-in-class small molecule CAM-E for chronic hepatitis B (CHB) Abstract #: 603 Title: Extended Treatment of HBeAg+ CHB Subjects with the Capsid Assembly Modulator ALG-000184 with or without Entecavir is Associated with Reductions in Viral Markers and Favorable Anti-HBeAb trendsPresenter: Professor Man-Fung Yuen, MBBS, MD, PhD, DSc, Chair and Chief of the Division of Gastroenterology and Hepatology, University of Hong Kong Abstract #: 895 Title: Dosing with the Capsid Assembly Modulator ALG-000184 in Untreated HBeAg Negative CHB Subjects Results in Potent Antiviral Effects Including Suppression of HBV DNA/RNA and Declines in HBcrAg LevelsPresenter: Kosh Agarwal, MBBS, MRCP (UK), MD, FRCP (Ed), FRCP (London), Consultant Hepatologist and Transplant Physician, Institute of liver Studies, King’s College Hospital NHS Foundation Trust Abstract #: 2390 Title: Association of baseline characteristics and plasma ALG-001075 to HBsAg responses in HBeAg+ CHB subjects following ALG-000184±ETV treatmentPresenter: Kha Le, PhD Preclinical Abstract #: 1298 Title: In vitro and in vivo pharmacological characterization of human PNPLA3-targeting short interfering RNA molecules for the treatment of metabolic dysfunction-associated steatohepatitisPresenter: Jieun Song, PhD Abstract #: 1338 (Top) Title: Second generation HBV siRNAs with novel chemistries demonstrate improved profiles compared with ALG-125755 and other clinical stage siRNAsPresenter: Jin Hong, PhD Abstract #: 1763 (Top) Title: Non-HAP CAM-A ALG-006746 and ALG-006780 induce rapid HBsAg reductions in AAV-HBV mice and have favorable pharmacokinetic profilesPresenter: Yannick Debing, PhD Abstracts identified as “Top” were selected as among the best in their category. These posters will be displayed during the four days of the congress. About Aligos Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of liver and viral diseases. Aligos’ strategy is to harness the deep expertise and decades of drug development experience its team has in liver and viral diseases to discover and develop potentially best-in-class therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) and viruses with high unmet medical need such as hepatitis B and coronaviruses. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including without limitation, statements regarding Aligos’ financial results and performance as well as research and development activities, including regulatory status and the timing of announcements and updates relating to our regulatory filings and clinical trials. Such forward looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance, or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties inherent in the drug development process, including Aligos’ clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, and other matters that could affect the sufficiency of Aligos’ capital resources to fund operations. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2024 and its future periodic reports to be filed or submitted with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. Investor ContactJordyn TaraziVice President, Investor Relations & Corporate Communications+1 (650) 910-0427jtarazi@aligos.com Media ContactMichael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com

100 Deals associated with Entecavir

External Link

KEGG	Wiki	ATC	Drug Bank
D04008	Entecavir	J05AF10	DB00442

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hepatitis B, Chronic	US	Bristol Myers Squibb Co.	29 Mar 2005

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic Disease	Phase 3	US	Bristol Myers Squibb Co.	01 Dec 2004
Chronic Disease	Phase 3	CA	Bristol Myers Squibb Co.	01 Dec 2004
Chronic Disease	Phase 3	HK	Bristol Myers Squibb Co.	01 Dec 2004
Chronic Disease	Phase 3	ID	Bristol Myers Squibb Co.	01 Dec 2004
Chronic Disease	Phase 3	PH	Bristol Myers Squibb Co.	01 Dec 2004
Chronic Disease	Phase 3	SG	Bristol Myers Squibb Co.	01 Dec 2004
Chronic Disease	Phase 3	TW	Bristol Myers Squibb Co.	01 Dec 2004
Chronic Disease	Phase 3	TH	Bristol Myers Squibb Co.	01 Dec 2004
liver function failure	Phase 3	US	Bristol Myers Squibb Co.	01 Aug 2003
liver function failure	Phase 3	BR	Bristol Myers Squibb Co.	01 Aug 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04536337 (ALG-000184-201, EASL2024) Manual	Phase 1	Hepatitis B, Chronic	22	ALG-000184 + Entecavir	nwpckmpgdt(lenxvnvqwi) = gktmevevai njffwrabiy (ytijyavyhc, 0.4) View more	Positive	01 Jun 2024
				ALG-000184	-
NCT04536337 (ALG-000184-201, EASL2024) Manual	Phase 1	Hepatitis B, Chronic	22	ALG-000184 + ETV	dqmahhdgen(lspszpmuha) = In a multiple regression model, baseline HBsAg (< or ≥4 log10 IU/ ml) and steady state plasma ALG-001075 exposure (AUC or Ctrough) statistically significantly predicted change from baseline in HBsAg at week 24 (p < 0.00018, R2 = 0.65). ywopmjqlqe (hvixtumffo ) View more	Positive	01 Jun 2024
				ALG-000184
NCT03887702 (CTgov)	Phase 3	Hepatitis B \| Malignant Solid Neoplasm	4	Tenofovir Alafenamide+Tenofovir Disoproxil Fumarate+Entecavir (Arm 1 (TAF, TDF, Entecavir: Prophylactic))	awzjjrvkmr(kzxybtxrkv) = wsuahhonyb nansxtcezr (fnhnsfeqfv, dlkdqekozh - zmikrphmip) View more	-	20 May 2024
				Tenofovir Alafenamide+Tenofovir Disoproxil Fumarate+Entecavir (Arm 2 (TAF, TDF, Entecavir: Upon Indication))	awzjjrvkmr(kzxybtxrkv) = chhrrdejkm nansxtcezr (fnhnsfeqfv, knkkrunzbl - inqtlqhjhh) View more
NCT03083821 (CTgov)	Phase 1	Hepatitis B	6	Baraclude	rbtngeeojm(qvnvvtvawg) = iyxrnyzlvv dgzftdyqed (zidwafjdoi, wrnnkkkkav - amsfdqupwr) View more	-	18 Nov 2023
AASLD2023	Not Applicable	Decompensated cirrhosis of liver	283	Entecavir	hojmcsuwda(xqpghayrrb) = trgxxtaksn uvodzcxagk (kygzkejrzz ) View more	-	10 Nov 2023
				Entecavir	hojmcsuwda(xqpghayrrb) = thhlhgptjv uvodzcxagk (kygzkejrzz ) View more
AASLD2023	Not Applicable	Hepatitis B, Chronic	-	Entecavir (ETV)	snhrhmwpfe(wtdgzvairp) = iachcfxzsc twiofnfrve (uupankkspt )	-	10 Nov 2023
				Tenofovir alafenamide (TAF)	snhrhmwpfe(wtdgzvairp) = tmwalyhrpd twiofnfrve (uupankkspt )
AASLD2023	Not Applicable	Hepatitis B	194	Entecavir	dncirbqfuh(ewhuxcdsir) = nimknsporf dlvxtvtiwh (srenmfcofn, 18.0 - 31.0) View more	-	10 Nov 2023
AASLD2023	Not Applicable	Hepatitis B, Chronic	268	Entecavir	ehqdfqnxrb(cntaucawxz) = mfcnnyqaaz jhehakqjug (wxuatspkaz ) View more	-	10 Nov 2023
				Tenofovir alafenamide	ehqdfqnxrb(cntaucawxz) = kwxxjonlll jhehakqjug (wxuatspkaz ) View more
NCT04781647 (CTgov)	Phase 2	Hepatitis B, Chronic	54	ETV+ABI-H0731 (ABI-H0731 + ETV)	bnqskgfstx(sqbemingvy) = vvnvhnbxxe zgehusewvi (aobknbqxfp, mxojoweiav - fpjcuvlyym) View more	-	06 Oct 2023
				Peg-IFNα+ETV+ABI-H0731 (ABI-H0731 + ETV + Peg-IFNα)	bnqskgfstx(sqbemingvy) = vawabztjmr zgehusewvi (aobknbqxfp, cesczszxne - aizqxoqztw) View more
NCT04536337 (ALG-000184-201, EASL2023)	Phase 1	Hepatitis B, Chronic	-	ALG-000184 300 mg + entecavir	ankwohanrw(eghckjrbms) = ryagsanxum yclcmyrrxh (aiaiwjrbpr ) View more	-	21 Jun 2023

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