According to Zhitong Finance App, Tengsheng Pharmaceutical-B (02137) announced the end of treatment (EOT) and follow-up results of its Phase IIb ENRICH and ENHANCE study in the form of three latest breakthrough reports at the American Society for Liver Disease Research (AASLD) Liver Disease Annual Meeting® held in Denver, Colorado, USA from November 5 to 9, 2026.
The latest results further enrich the data accumulated by the five BRII-179 Phase II studies. In particular, the ENSURE, ENRICH, and ENHANCE studies thoroughly assessed the potential of BRII-179 in activating HBV-specific immune responses and enriching participants with immune response characteristics through hierarchical progressive research design, and provided a basis for designing combination treatment plans aimed at achieving long-lasting hepatitis B surface antigen (HBsAg) clearance and functional cure.
For the first time, the ENSURE study cohort 4 observed the potential immune activation and enrichment effects of BRII-179: participants treated with BRII-179 showed a higher functional cure rate, particularly those producing a hepatitis B surface antibody (anti-HbS) response. The ENRICH study then prospectively evaluated the strategy: participants first received BRII-179 treatment for 12 weeks (given every 3 weeks or 2 weeks), followed by elebsiran and polyethylene glycol interferon α (PEG-IFNα) treatment.
Of the two BRII-179 dosing regimens in the ENRICH study, 41.9% of participants achieved HBsAg clearance during EOT, and 32.4% maintained HBsAg clearance 24 weeks after EOT; both results were consistent with those observed in the ENSURE study cohort 4.
The ENHANCE study further assessed how BRII-179 could be incorporated into a triple treatment regimen composed of BRII-179, elebsiran, and PEG-IFNα. In section A1, BRII-179, elebsiran, and PEG-IFNα simultaneous triple treatment had higher HBSAG clearance during EOT than PEG-IFNα monotherapy (25.5% and 10.2%, respectively), and this trend continued until 24 weeks after EOT (17.3% and 6.1%, respectively). Part A2 of the ENHANCE study evaluated a sequential combination strategy, that is, first using BRII-179 plus Elebsiran for 24 weeks of immune activation, then shortening the ElebsiRan combination to 24 weeks of PEG-IFNα treatment. At EOT, 22.5% of participants achieved HBsAg clearance. Participants who achieved an anti-HBS response after immunization with BRII-179 plus Elebsiran (defined as anti-HbS ≥ 10 IU/L at week 24) had a higher HBsAg clearance rate at EOT than non-responders (30.6% and 15.9%, respectively). Eight weeks after EOT, the overall HBsAg clearance rate of participants increased further to 25.0%, while the HBsAg clearance rate of anti-HBS responders increased to 33.3%. These results further reveal the immune-activating effect of BRII-179 and its potential to improve response to subsequent siRNA and PEG-IFNα combination therapy.
Both the Enrich and Enhance studies observed encouraging HBsAg clearance in participants with higher baseline HBsAg levels. In the ENRICH study, 32.1% of participants with baseline HBsAg levels above 1,000 IU/ml and no more than 3,000 IU/ml achieved HBsAg clearance during EOT, and 20.8% maintained HBsAg clearance 24 weeks after EOT. In the A1 section of the ENHANCE study, participants with baseline HBsAg levels above 1,000 IU/ml had HBsAg clearance rates of 24.2% and 18.2% during EOT and 24 weeks after EOT, respectively, while none of the participants in the PEG-IFNα monotherapy group achieved HBsAg clearance at either time point. In the A2 section of the ENHANCE study, 14.6% and 16.7% of participants in this high baseline subgroup also achieved HBsAg clearance at EOT and 8 weeks after EOT, respectively. These results support further evaluation of BRII-179-based immune activation strategies in patients with higher baseline HBsAg, a population that has historically been difficult to achieve functional cure.
The treatment options in the studies were generally safe and well tolerated.
Dr. David Margolis, Chief Medical Officer of Tengsheng Pharmaceuticals, said, “Our Phase IIb study results provide a more solid scientific basis for continuing to evaluate immune activation and enrichment strategies based on BRII-179. At the same time, these results also provide important insights into how BRII-179 can be used to activate HBV-specific immunity and how to guide subsequent treatment based on early immune response. Combining these findings, it is expected to guide future clinical study design, including research on people with high baseline HBsAg levels and where it is more difficult to achieve functional cure.”