Currently, there are over 250 million individuals world-wide who are chronically infected with hepatitis B virus (HBV) who are at risk from complications due to liver disease and liver cancer. HBV infection is currently managed with nucleos(t)ide reverse transcriptase inhibitors (NrtIs) that suppress HBV DNA replication and normalize alanine aminotransferase (ALT) levels leading to significant reductions in morbidity and mortality. Unfortunately, however, these agents are not curative and patients exhibit poor off-treatment responses that require indefinite therapy.
In June 2021, Venatorx announced that the first patient was dosed in a Phase 1 clinical trial evaluating VNRX-9945, a highly potent, broadly active viral replication inhibitor for the treatment of chronic hepatitis B virus (HBV) infection.
VNRX-9945 is a third-generation, orally bioavailable core protein allosteric modulator (CpAM). CpAMs represent an attractive class of direct-acting antivirals that block the formation of new virus particles and cccDNA in vitro.1 In preclinical studies, VNRX-9945 demonstrated broad antiviral activity against multiple HBV genotypes in vitro and suppressed HBV DNA to below the lower limit of quantitation in an animal model of HBV infection.
The Phase 1 clinical trial will evaluate the safety and pharmacokinetics of single and multiple ascending doses of VNRX-9945, administered orally in healthy adult volunteers (ClinicalTrials.gov – NCT04845321).
1 Berke, J.M. et al. Capsid assembly modulators have a dual mechanism of action in primary human hepatocytes infected with hepatitis B virus. Antimicrobial Agents and Chemotherapy 2017, 61: e00560-17.
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