Barinthus Bio Shares Promising Phase 2b Hepatitis B Trial Data

Barinthus Bio Shares Promising Phase 2b Hepatitis B Trial Data

Barinthus Biotherapeutics plc (NASDAQ: BRNS) has announced groundbreaking results from its ongoing Phase 2b HBV003 clinical trial. This trial is crucial as it focuses on chronic hepatitis B, a significant health challenge worldwide. With innovative therapies in development, Barinthus Bio aims to improve the lives of individuals confronting chronic infectious diseases.

Key Findings from the HBV003 Clinical Trial

The data shared recently have revealed that eight participants achieved HBsAg loss at various points during the study. More strikingly, two participants met the criteria for a functional cure, marking a remarkable achievement in the treatment of chronic hepatitis B. Functional cure refers to a sustained loss of HBsAg, where individuals no longer test positive for certain viral antigens in their blood.

Participant Progress and Outcomes

Among the participants, two who had discontinued nucleos(t)ide analogue (NUC) therapy also seroconverted, meaning they developed antibodies against the hepatitis B virus, which is a positive sign in the clinical outlook for these individuals. The clinical trial has enrolled 121 participants in total, with the study specifically examining different dosing regimens of the investigational drug VTP-300 in combination with low-dose nivolumab, an anti-PD-1 monoclonal antibody.

Insights from Clinical Experts

Dr. Chun-Jen Liu, an esteemed investigator of the HBV003 study, noted that achieving sustained HBsAg loss has historically been a significant challenge in the journey towards obtaining a functional cure for chronic hepatitis B. The latest findings indicate that VTP-300, when combined with low-dose nivolumab, may provide encouraging outcomes, with the potential to allow patients to cease antiviral therapy without experiencing a progression of the disease.

Assessment of NUC Discontinuation

A total of 40 participants who had HBsAg levels below 200 IU/mL at the beginning were evaluated for their ability to discontinue NUC treatment. Among those eligible for NUC cessation, eight achieved complete HBsAg loss, and notably, two of these participants did so after Day 169. The results underscore the possibility of durable therapeutic responses in a significant subset of participants.

Durable Responses and Safety Data

As the trial continues, the emerging data indicated that all treatment groups experienced durable declines in HBsAg levels, supporting previous findings presented elsewhere. Importantly, preliminary safety data suggest that the treatment combination of VTP-300 and low-dose nivolumab is generally well tolerated, with no serious adverse events linked to the treatment up to the data cutoff.

Potential Impact of HBsAb Positivity

Dr. Nadege Pelletier, the Chief Scientific Officer of Barinthus Bio, expressed excitement over the latest results, emphasizing that the ability of VTP-300 to enhance immune responses and induce sustained HBsAg reductions could represent a transformative step in the management of chronic hepatitis B. The observation that one participant who met the functional cure criteria developed antibodies against the virus suggests a promising avenue for long-term control of the infection.

Overview of the HBV003 Trial Methodology

The HBV003 trial is structured to gather vital information about the optimal dosing regimens for participants treated with VTP-300 and low-dose nivolumab. Participants receive targeted doses at strategic intervals to evaluate the timing of immune response activations. The trial's design reflects a significant evolution in selection criteria, with a focus now on those with lower HBsAg levels to elicit the strongest responses.

About VTP-300 and Barinthus Bio

VTP-300 is an innovative immunotherapeutic candidate developed by Barinthus Bio that integrates multiple HBsAg components to stimulate the immune response. The company is also investigating the potential of combining VTP-300 with other treatments to enhance efficacy and reduce immune suppression resulting from chronic hepatitis B infection. Founded on the principle of supporting those affected by serious diseases, Barinthus Bio is committed to advancing its clinical research pipeline, including other candidates aimed at tackling chronic infectious diseases and autoimmunity.

Frequently Asked Questions

What is the primary focus of the HBV003 clinical trial?

The HBV003 trial focuses on evaluating the effectiveness of the investigational drug VTP-300 in combination with low-dose nivolumab for treating chronic hepatitis B.

How many participants achieved functional cure in the trial?

In the most recent data, two participants achieved the criteria for functional cure defined by sustained HBsAg loss and undetectable hepatitis B virus DNA.

What does HBsAb positivity indicate in participants?

HBsAb positivity signifies that participants have developed antibodies against the hepatitis B virus, which may indicate a robust immune response and long-term control of the virus.

What is Barinthus Bio's mission?

Barinthus Bio aims to develop immunotherapeutic candidates to help individuals overcome chronic infectious diseases and autoimmunity, with a strong emphasis on patient support and innovative treatment solutions.

What is the next step for Barinthus Bio following this trial?

Barinthus Bio plans to continue monitoring participants in the HBV003 trial to evaluate long-term efficacy and safety, and to expand its research into additional treatments targeting chronic hepatitis B.

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