# Preclinical development of capsid assembly modulators for the treatment of chronic hepatitis B virus infection

> **NIH NIH R44** · VENATORX PHARMACEUTICALS, INC. · 2022 · $1,000,000

## Abstract

PROJECT SUMMARY
Despite the availability of a safe and effective vaccine, there remains over 257 million people chronically 
infected with hepatitis B virus (HBV) world-wide. Individuals with chronic HBV infections are at risk for 
complications due to liver disease and liver cancer. Chronic HBV is currently managed with nucleos(t)ide 
reverse transcriptase inhibitors (NrtI) which partly suppress HBV DNA replication, normalize alanine 
aminotransferase levels (ALT) and slow disease progression. Front-line therapies, however, are not curative 
and patients with chronic HBV exhibit poor off-treatment responses requiring life-long therapy. New antivirals 
and immunomodulatory approaches are, therefore, needed to further suppress viral replication and provide the 
conditions that are required for immune control known as a “functional cure”. One of the most promising 
classes of compounds under investigation are the core protein allosteric modulators (CpAM) that block HBV 
replication at multiple stages of the viral life-cycle. Here, we report on a best-in-class CpAM that exhibits potent 
pan-genotypic antiviral activity. In this project, we propose to advance our lead CpAM into definitive INDenabling studies to ready the compound for Phase 1 clinical trials in healthy volunteers and chronic HBV 
patients. Combination regimens that include a CpAM, antivirals possessing distinct mechanisms of action 
and/or novel immunomodulatory agents will be evaluated in a mouse model of HBV infection in preparation for 
Phase 2 development in chronic HBV patienst.

## Key facts

- **NIH application ID:** 10408826
- **Project number:** 5R44AI155308-02
- **Recipient organization:** VENATORX PHARMACEUTICALS, INC.
- **Principal Investigator:** Glen Coburn
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $1,000,000
- **Award type:** 5
- **Project period:** 2021-05-24 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10408826

## Citation

> US National Institutes of Health, RePORTER application 10408826, Preclinical development of capsid assembly modulators for the treatment of chronic hepatitis B virus infection (5R44AI155308-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10408826. Licensed CC0.

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