What Is Bepirovirsen?
Bepirovirsen is an investigational drug currently being studied for the treatment of Hepatitis B. Based on the available trial descriptions, the specific mechanism of action of bepirovirsen is not detailed, beyond its administration in clinical studies. It is being evaluated in clinical trials sponsored by GlaxoSmithKline.
This medication is being explored for its potential to address various forms of Hepatitis B. Clinical trials are assessing its safety and effectiveness in participants diagnosed with conditions such as Hepatitis B, chronic Hepatitis B, and chronic Hepatitis B virus infection. The aim is to understand how bepirovirsen might help manage or treat these viral infections.
A total of 9 clinical trials have been conducted or are currently underway for bepirovirsen. These studies have involved a total enrollment of 3,036 participants. The first clinical trial for bepirovirsen began on 2021-07-08, and the latest trial is projected to conclude on 2025-09-11.
Uses and Conditions Under Study
Bepirovirsen is currently under investigation for the treatment of Hepatitis B and related chronic conditions. Hepatitis B is a viral infection that primarily affects the liver, potentially leading to severe liver damage and other health complications if left untreated. The drug is being studied for its potential to manage or clear the Hepatitis B virus from the body.
All 9 clinical trials for bepirovirsen focus on conditions related to Hepatitis B. These include:
- Hepatitis B: This broad category encompasses the general viral infection. 7 trials have explored bepirovirsen for this condition.
- Chronic Hepatitis B: This refers to long-term infection with the Hepatitis B virus. Bepirovirsen has been studied in 2 trials specifically for chronic Hepatitis B.
- Hepatitis B, Chronic: Similar to chronic Hepatitis B, this condition is also being investigated. Bepirovirsen has been studied in 2 trials for this specific phrasing of the condition.
- Chronic Hepatitis B Virus Infection: This term emphasizes the persistent presence of the virus in the body. Bepirovirsen has been explored in 1 trial for this condition.
These studies aim to evaluate the safety and efficacy of bepirovirsen in participants with varying forms of Hepatitis B, including those who are not on nucleos(t)ide analog (NA) therapy, those who are on NA therapy, and those who have ceased NA therapy. The goal is to determine if bepirovirsen can offer a new therapeutic option for individuals living with this chronic viral infection.
Dosing
Bepirovirsen has been studied in various forms and administration methods within clinical trials. The available data indicates that bepirovirsen is administered via injection.
Specific dosage forms mentioned in studies include:
- Bepirovirsen Vial: Administered by a Healthcare Professional (HCP).
- Bepirovirsen PFS SSD (Pre-Filled Syringe Single Dose): This form has been administered by an HCP, and also self-administered by participants, both post-training and without training.
Clinical trials have also explored bepirovirsen in combination with other investigational drugs, such as Daplusiran/Tomligisiran, in various treatment arms. Studies have included different participant groups, such as those with severe or moderate renal impairment, healthy control participants, and individuals with different statuses regarding nucleos(t)ide analog (NA) therapy (not on NA, on NA, or NA-cessated).
The specific strengths or frequencies of bepirovirsen dosing are not detailed in the provided trial descriptions. Information regarding standard adult doses or investigational pediatric doses is also not available from the provided data.
Side Effects
The provided clinical trial data for Bepirovirsen does not include information on side effects. Therefore, a detailed summary of side effects cannot be generated at this time.
Clinical Trial Results
A study (NCT06058390) evaluated how Bepirovirsen is absorbed into the body when administered in different ways. The study measured the total amount of drug in the bloodstream over time (Area Under the Curve, or AUC) and the maximum concentration the drug reached (Cmax). These measurements help determine if different administration methods deliver consistent drug levels.
Administration by Healthcare Professional: Vial vs. Prefilled Syringe
When a healthcare professional administered a 300 mg dose of Bepirovirsen:
- The total drug exposure (AUC) was 118622.59 h*ng/mL using a prefilled syringe and 112495.66 h*ng/mL using a vial.
- The peak drug level (Cmax) was 10163.74 ng/mL using a prefilled syringe and 9954.89 ng/mL using a vial.
These results indicate that Bepirovirsen delivered by a healthcare professional provides similar drug levels in the body whether using a vial or a prefilled syringe.
Self-Administration by Patient: With and Without Training
The study also compared drug levels when a healthcare professional administered Bepirovirsen via prefilled syringe versus when patients self-administered the 300 mg dose.
For patients who self-administered after receiving training:
- The total drug exposure (AUC) was 120034.02 h*ng/mL when administered by a healthcare professional and 117805.29 h*ng/mL when self-administered.
- The peak drug level (Cmax) was 10225.39 ng/mL when administered by a healthcare professional and 10421.21 ng/mL when self-administered.
For patients who self-administered without prior training:
- The total drug exposure (AUC) was 117938.68 h*ng/mL when administered by a healthcare professional and 114492.19 h*ng/mL when self-administered.
- The peak drug level (Cmax) was 10007.69 ng/mL when administered by a healthcare professional and 9896.63 ng/mL when self-administered.
Overall, these findings suggest that patients can effectively self-administer Bepirovirsen using a prefilled syringe, achieving drug levels in the body that are comparable to those achieved when administered by a healthcare professional, even without specific training. This indicates reliable and consistent drug delivery across different administration methods.
Currently Recruiting Trials
For individuals interested in contributing to the advancement of Bepirovirsen, there is currently one clinical trial actively recruiting participants. This study focuses on understanding the long-term effects of the drug, particularly for those who have already experienced positive outcomes in previous research.
The study NCT04954859, titled "Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)," is a global, multi-center, Phase 2 trial sponsored by GlaxoSmithKline. This important research aims to assess how long the benefits of Bepirovirsen treatment last in individuals living with Hepatitis B. Specifically, researchers are looking at the maintenance of a complete or partial treatment response that participants achieved in a prior Bepirovirsen study. A complete or partial response typically refers to a significant reduction or clearance of the virus, or an improvement in liver health markers. Understanding this durability is crucial for determining the sustained impact of the drug and its potential as a long-term management option for Hepatitis B.
This follow-up study is designed for participants who have previously taken part in a Bepirovirsen study and achieved a positive response. It includes different groups based on their prior treatment status for Hepatitis B: those who were not on nucleos(t)ide analogues (NA), those who were on NA, and those who had ceased NA treatment. By observing these diverse groups, researchers can gain insights into how Bepirovirsen's effects persist across various patient profiles. The trial plans to enroll approximately 450 participants, offering a significant opportunity to gather more data on Bepirovirsen's long-term efficacy in managing Hepatitis B. Your participation could provide valuable information to help shape future treatment strategies.
Where to Participate
The ongoing Bepirovirsen clinical trial is currently recruiting participants across a limited number of sites in the United States. This focused approach allows researchers to gather specific data from key locations.
If you are interested in participating, you can find study sites in the following cities and states:
- Sacramento, California
- Boston, Massachusetts
- Detroit, Michigan
To be eligible for this study, participants must be between 18 and 18 years of age. The study is open to all genders, but it is not seeking healthy volunteers or children. Participants must have previously taken part in a Bepirovirsen study and achieved a complete or partial response.
Development Timeline
The journey of Bepirovirsen began on July 8, 2021, when the first clinical trial was initiated. Since then, GlaxoSmithKline has been the sole sponsor, consistently driving the development of this promising compound.
Initially, the research pipeline for Bepirovirsen explored conditions such as Irritable Bowel Syndrome with Constipation (IBS-C) and hyperphosphatemia. However, the focus quickly expanded, with the program evolving to primarily address Hepatitis B, including chronic Hepatitis B virus infection. This strategic shift highlights the drug's potential in a critical area of unmet medical need.
To date, a total of 9 clinical trials have been launched for Bepirovirsen, enrolling over 3,036 participants. These trials have progressed through various stages of development, including three Phase 1 studies, three Phase 2 studies, and two Phase 3 studies, alongside one study that spanned Phase 1/Phase 2. This progression through different phases demonstrates a comprehensive and systematic approach to evaluating Bepirovirsen's safety and efficacy, with the latest trial projected to conclude by September 11, 2025.