Drug Watch

Compounds in Development for Chronic Hepatitis B

Updated October 2018

 

FAMILY/DRUG NAME

 

 

MECHANISM

 

COMPANY

 

WEBSITE


USA STATUS

Interferons: Mimic infection-fighting immune substances naturally produced in the body.

Intron A (Interferon alfa-2b)

Immunomodulator

Merck, USA

merck.com

Approved 1991

Pegasys (Peginterferon alfa-2a)

Immunomodulator

Genentech, USA

gene.com

Approved 2005


Nucleos(t)ide Analogues: Interfere with viral DNA polymerase used for HBV replication 

Epivir (Lamivudine)
*Generics available

Inhibits viral DNA polymerase

GlaxoSmithKline (GSK)

gsk.com

Approved 1998

Hepsera (Adefovir dipivoxil)
*Generics available

Inhibits viral DNA polymerase

Gilead Sciences, USA

gilead.com

Approved 2002

Baraclude (Entecavir)
*Generics available

Inhibits viral DNA polymerase

Bristol-Myers Squibb, USA

bms.com

Approved 2005

Tyzeka (Telbivudine)
*Generic available

Inhibits viral DNA polymerase

Novartis, USA

novartis.com

Approved 2006

Viread (Tenofovir)
*Generics available

Inhibits viral DNA polymerase

Gilead Sciences

gilead.com

Approved 2008

Vemlidy (TAF or tenofovir alafenamide)

Prodrug of tenofovir

Gilead Sciences

gilead.com 

Approved Nov. 2016

Levovir (Clevudine)

Inhibits viral DNA polymerase

Bukwang, S. Korea

bukwang.co.kr

Approved 2006 in S. Korea

Besivo (formerly ANA 380/LB80380)

Inhibits viral DNA polymerase

Ildong Pharma, S. Korea

ildong.com/en

Approved 2017 in S. Korea

Zadaxin 

Immunomodulator

SciClone, USA

sciclone.com

Approved outside USA

 

DIRECT ACTING ANTIVIRALS: Targets the virus and interferes in the HBV replication process 

 

TDF Pro Drugs: A modified tenofovir drug that can get into liver cells more easily

TXL (CMX 157)

Prodrug of tenofovir

ContraVir, USA

 

contravir.com

Phase II

 

Silencing RNA’s (siRNAs): Interferes and destroys viral RNA

ARB-1467

RNAi gene silencer (1.0)

Arbutus Biopharma, USA, with Arcturus

arbutusbio.com

Phase II

RG6004 (HBV LNA)

RNA targeted via Locked Nucleic Acid

Roche

roche.com

Phase I/II

ARO-HBV

RNAi gene silencer

Arrowhead Pharma, USA

arrowheadpharma.com

 Phase I/II

AB-729

RNAi gene silencer

Arbutus Biopharma, USA

arbutusbio.com

 Phase I

ALN-HBV

RNAi gene silencer

Alnylam and Vir Biotech, USA

alnylam.com

Preclinical

HB-103

RNAi gene silencer

Benitec, Australia

benitec.com

Preclinical

Lunar-HBV

RNAi gene silencer

Arcturus, USA with Janssen 

arcturusrx.com

Preclinical

DCR-HBVS

RNAi gene silencer

Dicerna, USA

dicerna.com

Preclinical

 

Entry Inhibitors: Interferes with HBV getting into liver cells

Myrcludex B

Entry inhibitor

Hepatera, Russia with MYR GmbH, Germany

myr-pharma.com

Phase II

 

Capsid Inhibitors: Interferes with the viral DNA protein shield

Morphothiadin (GLS4)

Capsid inhibitor

HEC Pharma,
PR China

pharm.hec.cn/en

Phase II

NVR 3-778

Capsid inhibitor

Janssen, USA

janssen.com

Phase II

ABI-H0731

Capsid inhibitor

Assembly Biosciences, USA

assemblybio.com

Phase II

JNJ 6379

Capsid Inhibitor

Janssen, USA

janssen.com/

Phase II

AIC 649

Capsid inhibitor

AiCuris, Germany

aicuris.com

Phase I

AB-423

Capsid inhibitor

Arbutus Biopharma, USA

arbutusbio.com

Phase I

AB-506

Capsid inhibitor

Arbutus Biopharma, USA

arbutusbio.com/

Phase I

ABI-H2158

Capsid inhibitor

Assembly Biosciences, USA

assemblybio.com

Phase I

RG7907

Capsid inhibitor

Roche, Switzerland

roche.com

Phase I

QL-007

Capsid inhibitor

Qilu, China

qilu-pharma.com

Phase I

GLP-26

Capsid inhibitor

Emory University

emory.edu

Preclinical

EP-027367

Capsid inhibitor

Enanta Pharmaceuticals, USA

enanta.com

Preclinical

QL-0A6a

Capsid inhibitor

Qilu, China

qilu-pharma.com

 Preclinical

 

HBsAg Inhibitors: Interferes with production of HBV surface antigen (sAg)

REP 2139

sAg inhibitor

Replicor, Canada

replicor.com

Phase II

REP 2165

sAg inhibitor

Replicor, Canada

replicor.com

Phase II

 

Antisense Molecules: Binds to the viral mRNA to prevent it from turning into viral protein

IONIS-HBVRx (GSK3228836)

Viral protein inhibitor

Ionis Pharma, USA with GSK

ionispharma.com

Phase I

IONIS-HBVLRx (GSK33389404)

Viral protein inhibitor

Ionis Pharma with GSK

ionispharma.com

Phase I


Ribonuclease H Inhibitors: Inhibit degradation of viral RNA

ARB-452 Viral RNase Inhibitor Arbutus Biopharma, USA arbutusbio.com Preclinical

 

INDIRECT ACTING ANTIVIRALS: Targets the human immune system to attack the HBV virus

 

Therapeutic Vaccines: Vaccine technology used to stimulate the immune system as a treatment 

INO-1800

Therapeutic vaccine

Inovio, USA

inovio.com

Phase I

HB-110

Therapeutic vaccine

Ichor Medical Systems with Janssen, USA

ichorms.com

Phase I

TG1050

Therapeutic vaccine

Transgene, France

transgene.com

Phase I

HepTcell

Therapeutic vaccine

Altimmune, USA

altimmune.com

Phase I

TomegaVax HBV

Therapeutic vaccine

TomegaVax, USA

tomegavax.com

Preclinical

MVA-VLP

Therapeutic vaccine

GeoVax Labs, USA

geovax.com

Preclinical

VR-CHB01

Therapeutic vaccine

Vical, USA

   


Immune Modulators: Enhance a natural immune response

AIC 649

Immune Modulator

AiCuris, Germany

aicuris.com Phase I

IMMTav

T Cell immunomodulator

Immunocore, USA

 immunocore.com  Preclinical

 

Innate Immune Defense Pathway: Compounds that activate the innate immune system 

RG7795

TLR-7 agonist

Roche

roche.com

Phase II

Inarigivir

RIG -1 and NOD2 agonist

Spring Bank Pharmaceuticals, USA
Gilead Sciences

springbankpharm.com
gilead.com

Phase II

GS9688

TLR-8 agonist

Gilead Sciences

gilead.com

Phase I

 

Host Acting Pathway: Compounds that induce programmed cell death (apoptosis)

APG-1387

Apoptosis Inducer

Ascentage Pharma, China

en.ascentagepharma.com

Phase I

CRV 431 (CPI 431-32)

Ciclofillin inhibitor

ContraVir, USA

contravir.com

Preclinical

Gene Editing

EBT106

CRISPR/Cas Excision Biotherapeutics, USA www.excisionbio.com Preclinical

HBV

CRISPR/Cas Intellia Therapeutics, USA intelliatx.com Preclinical

HBV

CRISPR/Cas Precision Biopharma, USA with Gilead precisionsciences.com Preclinical


Other

GC1102

sAg monoclonal antibody Green Cross, South Korea www.globalgreencross.com Phase II

EYP001

FXR agonist Enyo Pharma, France enyopharma.com Phase I 

LTCR-H2-1

T Cell immunotherapy Lion TCR, Singapore www.liontcr.com Preclinical

HBV

MicroRNA Regulus Therapeutics, USA regulusrx.com Preclinical

 

HEPATITIS DELTA VIRUS (HDV)

Lambda (Pegylated Interferon)

Immunomodulator

Eiger Biopharma, USA

eigerbio.com

Orphan drug designation
Phase III

Myrcludex B

Entry inhibitor

MYR-GmbH, Germany

myr-pharma.com

Breakthrough Therapy Designation
Phase II

Lonafarnib

Prenylation inhibitor

Eiger Biopharma, USA

eigerbio.com

FDA Fast Track Designation
Orphan drug designation
Phase II

REP 2139/ REP 2165

HBsAg inhibitor

Replicor, Canada

replicor.com

Phase II

Ezetimibe

NTCP inhibitor

Ziauddin University Hospital, Pakistan

zu.edu.pk

Phase II

ALN-HDV

RNAi gene silencer

Alnylam, USA

alnylam.com

Preclinical

GI-18000

Immune Response Stimulator

GlobeImmune

globeimmune.com

Preclinical