Barinthus Biotherapeutics has shared its most significant recent data from the ongoing Phase IIb HBV003 clinical trial for chronic hepatitis B.
The newest data was cut off on 30 September (for lab data) and 8 October (for clinical data). Eight patients were reported to have complete hepatitis B surface antigen (HBsAg) loss – defined as HBsAg levels below the lower limit of quantitation (<LLOQ, 0.05IU/mL).
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Two patients also met the criteria for functional cure, meaning that results demonstrated sustained HBsAg loss and hepatitis B virus DNA <LLOQ for six months off-treatment.
Two of the eight patients with HBsAg loss became positive for anti-hepatitis B antibodies (HBsAb) that they did not have before. This included one of the individuals who met functional cure criteria.
The HBV003 study contains 121 patients, 69 of whom entered the trial with HBsAg levels below 200IU/mL. The trial is ongoing, but current data indicates that stronger responses may occur in chronic hepatitis B patients treated with the combination of VTP-300 and a low dose of the anti-PD1 antibody nivolumab (groups 1 and 2).
Preliminary safety data also indicated that VTP-300 in combination with low-dose nivolumab was generally well tolerated. No treatment-related serious adverse events had been observed or reported as of the data cut-off.
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By GlobalDataThe data will be presented at the American Association for the Study of Liver Diseases (AASLD)’s 2024 liver meeting later today by Dr Chun-Jen Li, investigator on the Phase IIb HBV003 and director of the Hepatitis Research Center and Clinical Trial Center at the National Taiwan University Hospital.
NUC discontinuation in the trial
A total of 40 patients were assessed for nucleos(t)ide analogue (NUC) discontinuation. These were chronic hepatitis B patients with HBsAg below 200IU/mL at screening, who had reached day 169 of the trial. Of the 40 assessed patients, 24 were eligible for NUC discontinuation. Eight of these were the aforementioned patients who achieved HBsAg loss at any time. Two of these patients achieved it after day 169.
Of the 24 eligible, nine patients chose to discontinue NUCs. Of these nine, six remained off NUC therapy, and five remained off NUC therapy for over six months. Two of the six have met the criteria for functional cure, while two of the six seroconverted to HBsAb positivity.
The most recent results also demonstrated durable HBsAg declines across all treatment groups, consistent with data previously presented at the European Association for the Study of the Liver (EASL) Congress, in June 2024.
“Sustained HBsAg loss has proven to be the largest hurdle in getting chronic hepatitis B patients to functional cure,” said Dr Liu. “The data we are seeing with VTP-300 is unique because they indicate a durable loss of HBsAg in participants, including two who met the criteria for functional cure. Although the study is still ongoing, these early data may bring us a step closer to potentially allowing some patients with chronic hepatitis B to come off antiviral treatment without their chronic hepatitis B progressing.”
Chronic hepatitis B worldwide
Over 250 million people have chronic hepatitis B worldwide, according to World Health Organisation (WHO) guidelines issued earlier this year.
In a briefing issued at the time, GlobalData’s senior epidemiologist Molly Moran explained that the high infection and death rates were “driven by mother-to-child transmission or infection shortly after birth through infected body fluids”.
She commented: “There has been progress to reduce this mode of transmission, including timely universal infant HBV vaccination, which is nearly 100% effective against this virus. Immunisation coverage, however, is only 45% globally, with notably poor coverage in the WHO Africa Region, where only 20% of infants receive immunisation.
“Treatment for chronic hepatitis B infection by antivirals is very effective and improves survival and reduces progression of liver disease and subsequent development of liver cancer.”
According to data provided by GlobalData epidemiologists in April 2024, diagnosed prevalent cases of hepatitis B in the 16 major markets are expected to rise from 21,499,000 in 2024 to 22,430,000 cases in 2029. These include France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain and the UK.
However, new WHO guidelines aim to curb that trajectory by reducing new infections by 90% and deaths by 65% by 2030.
GlobalData is the parent company of Clinical Trials Arena.
