Promising New Treatment Under Study for Chronic Hepatitis B

Introduction to Chronic Hepatitis B and Current Treatments

Chronic hepatitis B (cHBV) is a severe liver infection caused by the hepatitis B virus. It is a global health issue, leading to chronic liver disease and liver transplants. According to the World Health Organization, over one million people died from HBV-related causes in 2022.

Treatments for cHBV typically involve lifelong medication that suppresses the virus but does not eliminate it. Cure rates are low, making the development of new treatments essential.

What is ABI-4334?

ABI-4334 is a next-generation capsid assembly modulator (CAM) being developed by Assembly Biosciences for the treatment of cHBV. CAMs are a type of antiviral drug that works through two main mechanisms: they inhibit the replication of the HBV DNA and prevent the formation of new viral reservoirs known as cccDNA.

ABI-4334 is designed to target both mechanisms, potentially offering a more effective treatment for cHBV compared to current therapies.

Previous Studies on ABI-4334

In earlier Phase 1a studies, ABI-4334 was administered to healthy individuals once daily. The results showed a favorable safety profile and adequate pharmacokinetics, meaning the drug behaved as expected in the body. Importantly, ABI-4334 achieved strong antiviral activity levels projected to greatly surpass the required thresholds for effectively targeting both HBV DNA replication and cccDNA formation.

New Phase 1b Clinical Trial

The new Phase 1b trial aims to test ABI-4334 in individuals with cHBV. This study will run for 28 days and will focus on assessing the drug’s safety, pharmacokinetics, and antiviral activity in people living with chronic HBV.

Participants in the trial may be either treatment-naïve or off-treatment and can be positive or negative for the hepatitis B e antigen (HBeAg). The trial will include up to 50 participants, divided into smaller groups to receive either the drug or a placebo.

What the Researchers Aim to Achieve

The primary goals of the Phase 1b study are to assess the safety and tolerability of ABI-4334 and to understand its effect on HBV DNA levels. These results will help determine the appropriate dosages for subsequent clinical trials.

The study will also investigate how ABI-4334 influences the formation of cccDNA, offering insights into the drug's potential to provide a more long-lasting treatment for cHBV.

Experts' Opinions on the Study

Dr. Anuj Gaggar, Chief Medical Officer at Assembly Biosciences, expressed optimism about the trial. “We believe ABI-4334 has the potential to demonstrate best-in-class antiviral activity,” he said. The study will measure the drug’s impact on HBV DNA and gather key safety data.

Dr. Gaggar highlighted that interim results are expected to be reported later this year, providing initial insights into the drug’s clinical performance.

About Assembly Biosciences

Assembly Biosciences is a biotechnology company focused on creating innovative treatments for serious viral diseases. The company's mission is to develop life-changing therapies for patients living with chronic infections such as hepatitis B, herpesvirus, and hepatitis delta virus.

The team at Assembly Biosciences includes some of the leading experts in virologic drug development, committed to improving patient outcomes.

Looking Ahead

The successful development of ABI-4334 could mark a significant step forward in the treatment of chronic hepatitis B. This innovation has the potential to improve the lives of millions of people affected by this chronic viral infection.

For more information about the ongoing trial, you can visit clinicaltrials.gov using the identifier NCT06384131.