Hepatitis B Virus

Enanta Pharmaceuticals Announces Update to its Hepatitis B Virus (HBV) Program

Retrieved on: 
Thursday, November 18, 2021

Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease.

Key Points: 
  • Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease.
  • Enantas research and development efforts have produced clinical candidates currently in development for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and SARS-CoV-2 (COVID-19).
  • Enantas research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie.
  • These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law.

Enanta Pharmaceuticals Doses First Subject in a Phase 1 Clinical Study of EDP-721, Its Oral Hepatitis B Virus RNA Destabilizer

Retrieved on: 
Monday, August 16, 2021

We are pleased to advance our HBV program by dosing the first subject in our Phase 1 clinical study of EDP-721, an orally administered HBV RNA destabilizer that has the potential to reduce S antigen.

Key Points: 
  • We are pleased to advance our HBV program by dosing the first subject in our Phase 1 clinical study of EDP-721, an orally administered HBV RNA destabilizer that has the potential to reduce S antigen.
  • The current standard of care for chronic HBV involves nucleoside reverse transcriptase inhibitors, or NUCs, which can suppress HBV replication.
  • This two-part Phase 1a/b study will initially evaluate the safety, tolerability, and pharmacokinetics of EDP-721 in single and multiple ascending oral doses in healthy volunteers.
  • Enantas research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV), non-alcoholic steatohepatitis (NASH), and SARS-CoV-2 (COVID-19).

Enanta Pharmaceuticals Presents New Data for EDP-721, an Oral Hepatitis B Virus RNA Destabilizer, at the European Association for the Study of the Liver (EASL) International Liver Congress™

Retrieved on: 
Wednesday, June 23, 2021

The data demonstrate potent, selective and pangenotypic inhibition of HBV surface antigen (HBsAg), with up to a 3-log drop in the AAV-HBV mouse model.

Key Points: 
  • The data demonstrate potent, selective and pangenotypic inhibition of HBV surface antigen (HBsAg), with up to a 3-log drop in the AAV-HBV mouse model.
  • The research on EDP-721 was presented in a poster titled Discovery and Characterization of EDP-721, a Novel Hepatitis B Virus RNA Destabilizer, during the EASL International Liver Congress 2021.
  • Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease.
  • Enantas research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie.

Enanta Pharmaceuticals Reports Positive Data from Phase 1b Study of EDP-514, a Hepatitis B Virus (HBV) Core Inhibitor, in Viremic Chronic HBV Patients

Retrieved on: 
Tuesday, June 22, 2021

Ultimately, our all-oral, triple combination approach could provide potent suppression of multiple key steps in HBV replication, including HBV DNA, HBV RNA and HBsAg, to achieve our goal of developing a functional cure for HBV patients.

Key Points: 
  • Ultimately, our all-oral, triple combination approach could provide potent suppression of multiple key steps in HBV replication, including HBV DNA, HBV RNA and HBsAg, to achieve our goal of developing a functional cure for HBV patients.
  • The randomized, double-blind, placebo-controlled Phase 1b study is evaluating the safety, pharmacokinetics, and antiviral activity of three doses of EDP-514 in viremic patients with chronic HBV infection, either HBeAg-positive or HBeAg-negative, and without cirrhosis.
  • Hepatitis B is a viral infection that attacks the liver and can cause both acute and chronic disease.
  • Enantas research and development efforts have produced clinical candidates for the following disease targets: respiratory syncytial virus (RSV), hepatitis B virus (HBV) and non-alcoholic steatohepatitis (NASH).

Venatorx Pharmaceuticals to Present Preclinical Profile of its Hepatitis B Virus Clinical Candidate at the International Liver Congress 2021

Retrieved on: 
Monday, June 21, 2021

Title: Discovery and preclinical profile of VNRX-9945, a potent, broadly active core protein inhibitor for the treatment of hepatitis B virus (HBV) infection

Key Points: 
  • Title: Discovery and preclinical profile of VNRX-9945, a potent, broadly active core protein inhibitor for the treatment of hepatitis B virus (HBV) infection
    VNRX-9945 is a third-generation (highly potent), broadly active, orally bioavailable core protein allosteric modulator (CpAM) for the treatment of chronic hepatitis B virus (HBV) infection.
  • There are more than 250 million individuals chronically infected with chronic HBV worldwide who are at risk from complications due to liver disease and liver cancer.
  • In addition, Venatorx is entering Phase 1 with its first antiviral compound (VNRX-9945), a Hepatitis B virus inhibitor, in late June 2021.
  • Capsid assembly modulators have a dual mechanism of action in primary human hepatocytes infected with hepatitis B virus.

Enanta Pharmaceuticals Reports Positive Data from Part 2 of its Phase 1b Study of EDP-514 in Chronic Hepatitis B Virus Patients on Treatment with a Nucleoside Reverse Transcriptase Inhibitor

Retrieved on: 
Thursday, May 6, 2021

Patients were randomized to receive 200 mg (n=6), 400 mg (n=6), 800 mg (n=6) of EDP-514 or placebo (n=6) daily for 28 days.

Key Points: 
  • Patients were randomized to receive 200 mg (n=6), 400 mg (n=6), 800 mg (n=6) of EDP-514 or placebo (n=6) daily for 28 days.
  • EDP-514 was safe and well-tolerated and pharmacokinetics were supportive of once daily dosing, consistent with what was observed in Part 1 in healthy subjects.
  • Six of 12 patients given EDP-514 had at least one grade 1 or 2 AE during treatment.
  • It is estimated that over 290 million people worldwide have chronic HBV infection.1 Current approaches to treatment include interferon therapy and/or NUCs.

Enanta Pharmaceuticals Initiates Phase 1 Clinical Study of EDP-514, its Lead Core Inhibitor for the Treatment of Hepatitis B Virus (HBV)

Retrieved on: 
Monday, July 8, 2019

The study plans to enroll approximately 98 subjects and to evaluate up to 6 dose cohorts, with EDP-514 administered orally, once daily.

Key Points: 
  • The study plans to enroll approximately 98 subjects and to evaluate up to 6 dose cohorts, with EDP-514 administered orally, once daily.
  • Receipt of Fast Track designation from the FDA emphasizes the large unmet need of patients with chronic HBV infection.
  • EDP-514, a novel class II hepatitis B virus (HBV) core inhibitor, is Enantas lead core inhibitor candidate.
  • Glecaprevir, a protease inhibitor discovered by Enanta, is now sold by AbbVie in numerous countries as part of its newest treatment for chronic hepatitis C virus (HCV) infection.