Barinthus Biotherapeutics plc (NASDAQ: BRNS) has announced the completion of enrollment for two clinical trials: the Phase 2b HBV003 trial of VTP-300 in adults with chronic hepatitis B (CHB) and the Phase 1 PCA001 trial of VTP-850 in men with rising prostate-specific antigen (PSA) following definitive local therapy for prostate cancer.
Bill Enright, Chief Executive Officer of Barinthus Bio, stated, “We continue to execute our strategy and are pleased to complete the enrollment in two different trials in CHB and prostate cancer, two diseases where recruitment can be a real challenge. These two fantastic milestones keep us on track for anticipated data readouts from HBV003 in Q4 of 2024 and from PCA001 in the first half of 2025.”
HBV003: Phase 2b Trial for Chronic Hepatitis B
The Phase 2b HBV003 trial (NCT05343481) has enrolled 121 participants. The trial is designed to obtain critical dosing information for a potential functional cure regimen for CHB. Participants are receiving VTP-300 in combination with low-dose nivolumab.
This trial builds upon positive monotherapy results from the clinical study HBV002, which evaluated VTP-300 alone and in combination with low-dose nivolumab. Interim data from the HBV003 trial, presented at the European Association for the Study of the Liver (EASL) Congress, demonstrated that the treatment was generally well-tolerated and led to a sustained decline in Hepatitis B surface antigen (HBsAg) levels. Of the participants reaching Day 169, 76% met the criteria for NUC therapy discontinuation, and 19% achieved undetectable levels of HBsAg, with two patients maintaining these levels for over 16 weeks.
PCA001: Phase 1 Trial for Prostate Cancer
The PCA001 Phase 1 trial (NCT05617040) has enrolled 22 participants. The trial aims to determine the recommended Phase 2 dosing regimen of VTP-850 and to evaluate its safety and efficacy, as measured by PSA levels and T cell response. VTP-850 is a next-generation prostate cancer immunotherapeutic candidate that utilizes Barinthus Bio’s ChAdOx/MVA platform, employing a sequential dosing approach with two proprietary nonreplicating viral vectors.
Disease Burden and Current Treatment Landscape
Globally, approximately 254 million people live with chronic hepatitis B infection, including up to 2.4 million in the U.S. and 10.6 million in Europe. In 2022, approximately 1.1 million deaths were attributed to hepatitis B virus infection and related complications such as liver cirrhosis and hepatocellular carcinoma. Diagnosis rates remain low, with only 13% of those infected being aware of their condition and less than 3% receiving antiviral treatment as of the end of 2022.
Prostate cancer was the fourth most common cancer worldwide in 2020, with 1.4 million new cases diagnosed. In the U.S., about 13 out of every 100 men will develop prostate cancer during their lifetime. In the UK, it is the most common cancer in men, with over 52,000 new diagnoses each year. Between 20% and 30% of patients experience rising PSA levels after local therapy, indicating incomplete eradication of the disease. Of these men, there is a 1 in 9 chance of developing metastases.
