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Brii Bio Unveils New Data from Its Ongoing Phase 2 ENSURE Study at APASL 2025, Showcasing BRII-179's Unique Potential to Prime and Boost Higher HBsAg Loss Through Target Patient Identification

  • On March 30, 2025, Brii Biosciences Limited announced new data from the ongoing Phase 2 ENSURE study at the 34th Annual Meeting of the Asian Pacific Association for the Study of the Liver in Beijing, China, highlighting findings related to BRII-179 and elebsiran .
  • The ENSURE study aims to address the high unmet medical needs of the 254 million people globally infected with chronic Hepatitis B virus , a leading cause of liver disease, by evaluating novel therapeutic strategies.
  • The ENSURE study, a multicenter, open-label Phase 2 trial, includes cohorts evaluating elebsiran's contribution in combination with PEG-IFN and a novel enrichment strategy utilizing BRII-179 to identify immune responders among participants with chronic HBV infection and baseline HBsAg levels of 100-3,000 IU/mL.
  • According to Dr. Grace Lai-Hung Wong, Professor of Gastroenterology and Hepatology at CUHK Medical Data Analytics Centre , "The positive Cohort 4 data from the ENSURE study opens new doors for HBV functional cure,", while David Margolis, Chief Medical Officer of Brii Bio, stated that Cohort 4 continues to support their enrichment strategy for developing a functional cure for chronic HBV.
  • Emerging data from Cohort 4 revealed that 55.6% of BRII-179 responders achieved HBsAg seroclearance at Week 24, compared to 10.0% of non-responders, suggesting BRII-179's potential as a predictive tool and supporting the combination of elebsiran and PEG-IFN as generally safe and well-tolerated in virally suppressed chronic HBV patients, with treatment ongoing for 48 weeks.
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Brii Bio Unveils New Data from Its Ongoing Phase 2 ENSURE Study at APASL 2025, Showcasing BRII-179's Unique Potential to Prime and Boost Higher HBsAg Loss Through Target Patient Identification

Preliminary data from Cohort 4 of the ENSURE study supports a novel enrichment strategy to utilize BRII-179 to identify patients who are immune responders and have the potential to achieve higher HBsAg loss at EOT48-week EOT data from Cohort 1-3…

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The Herald-Dispatch broke the news in on Sunday, March 30, 2025.
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