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Hepatitis B trial clears virus marker in 42% of patientsHealth
Brii Bio’s Phase 2 data show 42% of hepatitis B patients cleared the surface antigen, a step towards a functional cure, though the treatment is experimental.
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An experimental hepatitis B treatment has cleared a key marker of the virus in more than four in ten patients in late-stage trials, according to new data presented by the drugmaker Brii Biosciences.
The results, presented at the American Association for the Study of Liver Diseases meeting in Denver, known as AASLD The Liver Meeting, come from two Phase 2 studies testing a strategy built around the company’s vaccine candidate BRII-179.
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In the Phase 2b ENRICH study, 41.9 percent of participants, 62 out of 148, achieved loss of hepatitis B surface antigen, known as HBsAg, by the end of treatment. Nearly a third, 32.4 percent or 48 out of 148, were still clear of the marker 24 weeks after treatment ended.
Hepatitis B surface antigen is the marker doctors use to track whether the virus is still active in the body. Losing it is considered a step towards a functional cure, in which the virus is controlled without the need for lifelong treatment.
In the ENHANCE study, a triple combination of BRII-179, elebsiran and pegylated interferon alfa achieved HBsAg loss in 25.5 percent of patients, 25 out of 98, at the end of treatment, compared with 10.2 percent, 5 out of 49, for interferon alone. At 24 weeks after treatment, the figures were 17.3 percent against 6.1 percent.
A shorter 24-week course of interferon after priming with BRII-179 and elebsiran still achieved HBsAg loss in 22.5 percent of patients at the end of treatment, the company said. That matters because interferon treatment is demanding, and a shorter course would be easier for patients to complete.
The results were also notable in a group that is historically hardest to treat. Among patients with higher baseline HBsAg, above 1,000 international units per millilitre, 32.1 percent in the ENRICH study achieved HBsAg loss by the end of treatment.
The regimens were generally safe and well tolerated, according to the company, with side effects consistent with the known profile of pegylated interferon alfa and no new safety signals reported.
The figures come from a company announcement rather than independent reporting, and the data are from Phase 2 trials, which test whether a treatment works in a few hundred patients. Larger Phase 3 trials would be needed before any treatment could be licensed.
Even with that caution, the results are significant because hepatitis B remains a major global health problem. More than 254 million people are infected worldwide, and about 820,000 die of complications each year, according to the figures cited in the announcement.
Current treatments can suppress the virus but rarely clear it, which is why a functional cure is one of the most sought-after goals in liver medicine. The Brii Bio data suggest that combining a therapeutic vaccine with other drugs may move closer to that goal than any single drug alone.
The company said the results support its priming and enrichment strategy, in which BRII-179 is used first to train the immune system, followed by other drugs to drive down the virus. Further studies will be needed to confirm whether the benefit lasts and which patients gain the most.
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