ASSEMBLY BIOSCIENCES, INC. (ASMB)
Assembly Biosciences, Inc. is a biotechnology firm in the clinical development phase, dedicated to identifying and advancing innovative therapeutic solutions for hepatitis B virus (HBV) infections within the United States. Its primary drug candidate, Vebicorvir, has successfully concluded Phase 2 clinical trials for individuals with chronic HBV. The company's development pipeline also features ABI-H3733, which has finished Phase 1a clinical studies, and ABI-4334, currently in pre-clinical assessment for HBV treatment. Assembly Biosciences has forged collaborative partnerships, including agreements with BeiGene, Ltd. and Arbutus Biopharma Corporation, as well as with Antios Therapeutics, Inc., to explore a triple-combination treatment strategy for chronic hepatitis B virus. Additionally, it maintains strategic licensing arrangements with Indiana University Research and Technology Corporation and Door Pharmaceuticals, LLC. Established in 2005, the company was formerly known as Ventrus Biosciences, Inc. before rebranding to Assembly Biosciences, Inc. in June 2014, and its headquarters are located in South San Francisco, California.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Assembly Biosciences, Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Terminated
Efficacy and Safety Study to Treat Subjects With Symptomatic Internal Hemorrhoids
Iferanserin, Placebo
Internal Hemorrhoids
NCT01355874Enrollment403StartJul 2011Primary CompletionJun 2012CompletionJun 2012 - Phase 3Completed
Efficacy and Safety Study With Diltiazem Hydrochloride Cream to Treat Anal Fissures
VEN 307, Placebo
Chronic Anal Fissures
NCT01690221Enrollment434StartOct 2012Primary CompletionDec 2013CompletionJan 2014 - Phase 2Completed
Efficacy Study of Iferanserin to Treat Hemorrhoids
Iferanserin, Placebo
Hemorrhoids
NCT01483833Enrollment121StartSep 2001Primary CompletionAug 2002CompletionAug 2002 - Phase 2Completed
A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection
ABI-H0731, SOC NUC
Chronic Hepatitis B
NCT03576066Enrollment73StartJun 2018Primary CompletionJul 2019CompletionJul 2019 - Phase 2Completed
A Study Evaluating ABI-H0731+ Entecavir vs Entecavir Alone for the Treatment of Viremic HBeAg-positive Participants With Chronic Hepatitis B Virus Infection (cHBV)
ABI-H0731, SOC ETV
Chronic Hepatitis B
NCT03577171Enrollment25StartJun 2018Primary CompletionJun 2019CompletionJun 2019 - Phase 2Terminated
A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients
standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI)
Chronic Hepatitis B
NCT03780543Enrollment92StartDec 2018Primary CompletionApr 2021CompletionApr 2021 - Phase 2Terminated
A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection
ABI-H2158, Placebo
Chronic Hepatitis B
NCT04398134Enrollment88StartAug 2020Primary CompletionOct 2021CompletionDec 2021 - Phase 2Terminated
A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors
ABI-H0731, Placebo
Chronic Hepatitis B
NCT04454567Enrollment2StartNov 2020Primary CompletionApr 2021CompletionApr 2021 - Phase 2Terminated
A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection
ABI-H0731, ETV
Chronic Hepatitis B
NCT04781647Enrollment54StartFeb 2021Primary CompletionDec 2022CompletionDec 2022 - Phase 2Terminated
A Study Evaluating Treatment Regimens Containing Vebicorvir (ABI-H0731) in Participants With Chronic Hepatitis B Infection
VBR, AB-729
Chronic Hepatitis B
NCT04820686Enrollment65StartMay 2021Primary CompletionMar 2023CompletionMar 2023 - Phase 2Not yet recruiting
A Study to Assess the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection
ABI-6250, ABI-6250
Chronic Hepatitis D Infection
NCT07762027Enrollment80StartOct 2026est.Primary CompletionJun 2027est.READOUTCompletionSep 2028est. - Phase 1/2Completed
Phase 1b/2a Study of ABI-H0731 in Patients With Chronic Hepatitis B
ABI-H0731, Placebo for ABI-H0731
Chronic Hepatitis B
NCT03109730Enrollment38StartJun 2017Primary CompletionMar 2018CompletionJun 2018 - Phase 1Unknown status
An Open-Label, Single- and Multi-Dose Pharmacokinetic (PK) Study of Oral Diltiazem and Topical Diltiazem Hydrochloride
Diltiazem Hydrochloride Cream and Oral Diltiazem
Adult Subjects With Anal Fissures.
NCT01816191Enrollment12StartFeb 2013Primary CompletionJul 2013CompletionSep 2013est. - Phase 1Unknown status
Topical Safety Study of Topical Diltiazem Hydrochloride
Diltiazem Hydrochloride 2% Cream, Vehicle Cream
Diltiazem Skin Sensitivity.
NCT01816529Enrollment200StartMar 2013Primary CompletionJun 2013CompletionSep 2013est. - Phase 1Unknown status
A 21-Day Topical Safety Study of Diltiazem Hydrochloride Using a Cumulative Irritant Patch Test Design
Diltiazem Hydrochloride 2% Cream, Vehicle Cream
Skin Irritation
NCT01821274Enrollment30StartMar 2013Primary CompletionJul 2013CompletionSep 2013est. - Phase 1Completed
Study to Evaluate the Interaction Potential of Clarithromycin XL on Diltiazem Hydrochloride Cream 2% in Healthy Subjects
Clarithromycin XL, 2% Diltiazem
CLARITHROMYCIN/DILTIAZEM [VA Drug Interaction]
NCT02080780Enrollment24StartSep 2013Primary CompletionOct 2013CompletionOct 2013 - Phase 1Completed
A Study in Healthy Volunteers and Patients With Chronic Hepatitis B
ABI-H0731, Placebo for ABI-H0731
Chronic Hepatitis B
NCT02908191Enrollment86StartNov 2016Primary CompletionMar 2018CompletionJun 2018 - Phase 1Completed
A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B
ABI-H2158, Placebo for ABI-H2158
Chronic Hepatitis B
NCT03714152Enrollment80StartNov 2018Primary CompletionNov 2020CompletionJan 2021 - Phase 1Terminated
ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis
ABI-M201, Placebo
Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate
NCT03923478Enrollment15StartJun 2019Primary CompletionJan 2021CompletionJan 2021 - Phase 1Completed
A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults
ABI-H2158 Reference Formulation, ABI-H2158 Test Formulation
Chronic Hepatitis B
NCT04083716Enrollment15StartSep 2019Primary CompletionOct 2019CompletionOct 2019 - Phase 1Completed
A Study to Assess CYP3A4 Modulator, Oral Contraceptive, and pH Modifier Drug Interactions for ABI-H2158 in Healthy Adults
ABI-H2158, Itraconazole
Chronic Hepatitis B
NCT04142762Enrollment80StartOct 2019Primary CompletionJan 2020CompletionJan 2020 - Phase 1Completed
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults
ABI-H3733 Liquid Oral Dosage Form, ABI-H3733 Solid Oral Dosage Form
Chronic Hepatitis B
NCT04271592Enrollment120StartMay 2020Primary CompletionNov 2020CompletionJan 2021 - Phase 1Completed
A Study to Evaluate the Mass Balance Absorption and AME of VBR
Vebicorvir (VBR)
Chronic Hepatitis B
NCT04637139Enrollment6StartDec 2020Primary CompletionDec 2020CompletionDec 2020 - Phase 1Completed
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
ABI-H3733, Placebo
Chronic Hepatitis B
NCT05414981Enrollment31StartAug 2022Primary CompletionApr 2023CompletionApr 2023 - Phase 1Completed
A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects
ABI-4334 Tablet, ABI-4334 Placebo
Chronic Hepatitis B
NCT05569941Enrollment54StartNov 2022Primary CompletionApr 2023CompletionApr 2023
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Terminated | Iferanserin, Placebo | NCT01355874 |
| Phase 3 | Completed | VEN 307, Placebo | NCT01690221 |
| Phase 2 | Completed | Iferanserin, Placebo | NCT01483833 |
| Phase 2 | Completed | ABI-H0731, SOC NUC | NCT03576066 |
| Phase 2 | Completed | ABI-H0731, SOC ETV | NCT03577171 |
| Phase 2 | Terminated | standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI) | NCT03780543 |
| Phase 2 | Terminated | ABI-H2158, Placebo | NCT04398134 |
| Phase 2 | Terminated | ABI-H0731, Placebo | NCT04454567 |
| Phase 2 | Terminated | ABI-H0731, ETV | NCT04781647 |
| Phase 2 | Terminated | VBR, AB-729 | NCT04820686 |
| Phase 2 | Not yet recruiting | ABI-6250, ABI-6250 | NCT07762027 |
| Phase 1/2 | Completed | ABI-H0731, Placebo for ABI-H0731 | NCT03109730 |
| Phase 1 | Unknown status | Diltiazem Hydrochloride Cream and Oral Diltiazem | NCT01816191 |
| Phase 1 | Unknown status | Diltiazem Hydrochloride 2% Cream, Vehicle Cream | NCT01816529 |
| Phase 1 | Unknown status | Diltiazem Hydrochloride 2% Cream, Vehicle Cream | NCT01821274 |
| Phase 1 | Completed | Clarithromycin XL, 2% Diltiazem | NCT02080780 |
| Phase 1 | Completed | ABI-H0731, Placebo for ABI-H0731 | NCT02908191 |
| Phase 1 | Completed | ABI-H2158, Placebo for ABI-H2158 | NCT03714152 |
| Phase 1 | Terminated | ABI-M201, Placebo | NCT03923478 |
| Phase 1 | Completed | ABI-H2158 Reference Formulation, ABI-H2158 Test Formulation | NCT04083716 |
| Phase 1 | Completed | ABI-H2158, Itraconazole | NCT04142762 |
| Phase 1 | Completed | ABI-H3733 Liquid Oral Dosage Form, ABI-H3733 Solid Oral Dosage Form | NCT04271592 |
| Phase 1 | Completed | Vebicorvir (VBR) | NCT04637139 |
| Phase 1 | Completed | ABI-H3733, Placebo | NCT05414981 |
| Phase 1 | Completed | ABI-4334 Tablet, ABI-4334 Placebo | NCT05569941 |
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