Direct evidence that BRII-179-induced functional antibody responses lead to increased and sustained HBsAg loss
New insights into using BRII-179 to enhance patients’ intrinsic humoral immune response to improve HBsAg disappearance or HBV functional cure rate
New data supports entry into late-stage clinical development, data expected to inform treatments for chronic hepatitis B
Durham, North Carolina and Beijing, November 13, 2023 /PRNewswire/ — Brii Biosciences Limited (“Borui Biotechnology” or the “Company”, stock code: 2137.HK), a biotechnology company dedicated to developing therapies to improve patient health and options for diseases with unmet need, today shared three documents at the American Association for the Study of Liver Diseases (AASLD) Poster Liver Conference® exist Boston, Massachusettstwo of which are considered late-stage breakthroughs, presented new data from two Phase 2 assets BRII-179 (VBI-2601) and BRII-835 (VIR-2218) in chronic hepatitis B (CHB) clinical programs.
“We are pleased to share these data at the Liver Conference, which demonstrate the versatility of our HBV portfolio and the important insights we have in the search for a cure for HBV,” said David MargolisMD, Chief Medical Officer Borui Biotechnology. “The important link between HBsAg loss and antibody responses provides clear direction for further improving functional cure rates and identifying patients most likely to respond to curative treatments. Our goal is to provide the right Developing the right treatment options for the right patient population while sparing patients from expensive or poorly tolerated treatment options that may not be of benefit to them.”
In the latest poster presentation, Borui Biotechnology Announced additional interim data from a cohort-level, randomized, placebo-controlled, double-blind Phase 2 study of BRII-179 in combination with pegylated interferon-alpha (PEG-IFNα) in patients with CHB infection. Blind data. Findings from this presentation include:
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Add-on therapy with BRII-179 to existing PEG-IFNα therapy was generally safe and tolerated, with adverse events similar to those previously reported for PEG-IFNα therapy and BRII-179.
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At week 36 (12 weeks after end of treatment (EOT)), the BRII-179 + PEG-IFNα combination group achieved greater HBsAg disappearance compared with the placebo + PEG-IFNα group (Full Analysis Set (FAS) :24.6% vs. .14.0%, per protocol set (PPS): 31.8% vs. 14.9%). Differences in HBsAg disappearance rates were observed at week 24 (EOT) and maintained through week 36. Clinical studies also found that the HBsAg seroconversion rate in the combination group was significantly higher than that in the placebo + PEG-IFNα group (FAS: 15.8% vs. 1.8) %, p=0.016; PPS: 19.6% 2.0%, p=0.0058) at week 24 (EOT).
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The addition of BRII-179 induced a robust and functional HBsAg antibody response, with participants in the BRII-179 + PEG-IFNα combination group achieving significantly higher HBsAg antibody responses than those in the placebo + PEG-IFNα group at week 24. Hepatitis B surface antibody (HBsAb) response rate (FAS: 38.6% vs. 14.0%, p=0.0052; PPS: 39.1% 13.7%, p=0.0054) and Week 36 (FAS: 33.3% vs. 12.3%, p=0.0131; PPS: 34.1% 10.6%, p=0.0105). HBsAb titer was significantly associated with HBsAg loss at 24 and 36 weeks. No antibody response was detected in 4 of 5 rebound patients.
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Data from this proof-of-concept study demonstrate that adding BRII-179 to induce a functional immune response can improve the rate and duration of HBsAg disappearance in chronic hepatitis B patients treated with PEG-IFNα, thereby improving the rate of functional cure of chronic hepatitis B .
In the second latest poster presentation, Borui Biotechnology Presented translational research data from the BRII-179-001 and BRII-179-835-001 studies demonstrating that the unique HBsAg antibody response induced by BRII-179 was only observed in a subset of CHB subjects, suggesting that some patients have HBV-specific The intrinsic immune response may be more severely compromised. Additionally, the researchers found:
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BRII-179 in combination with BRII-835 (VIR-2218) was generally well tolerated at doses up to 9 months, with no >Grade 2 treatment-related adverse events.
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In participants with chronic hepatitis B receiving nucleos