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慢性乙型肝炎病毒(HBV)功能性治愈
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腾盛博药-B(02137)于2025亚肝会上公布了其正在进行的ENSURE 2期研究的最新数据
智通财经网· 2025-03-30 11:13
Core Insights - The company announced the latest data from its ongoing ENSURE Phase 2 study at the 34th Asia-Pacific Association for the Study of the Liver meeting, highlighting the potential of elebsiran in treating chronic hepatitis B virus (HBV) infection [1][2] Group 1: Study Findings - The ENSURE study (NCT05970289) is a multi-center, open-label Phase 2 trial assessing the efficacy of elebsiran, a research small interfering RNA (siRNA), in combination with PEG-IFNα for chronic HBV patients with baseline HBsAg levels between 100-3,000 IU/mL [1] - In cohort 4, participants who previously responded to BRII-179 treatment showed a significantly higher HBsAg seroclearance rate of 55.6% (10/18) compared to 10.0% (1/10) in non-responders at week 24 [2][4] - The overall HBsAg seroclearance rate in cohort 4 was 39.3% (11/28) at week 24, indicating the potential of BRII-179 as a predictive tool for identifying patients likely to respond to curative therapies [2][4] Group 2: Treatment Efficacy - Participants receiving elebsiran in combination with PEG-IFNα had higher HBsAg seroclearance rates and seroconversion rates at the end of treatment (EOT) compared to those receiving PEG-IFNα alone [2][6] - At EOT, the HBsAg seroclearance rates for the elebsiran 200 mg and 100 mg plus PEG-IFNα groups were 26.3% (5/19) and 33.3% (6/18), respectively, significantly higher than the 5.6% in the PEG-IFNα monotherapy group [6] - The average HBsAg decline was greater in the elebsiran plus PEG-IFNα groups, with reductions of -2.47 and -3.01 log10 IU/mL compared to -1.02 log10 IU/mL in the PEG-IFNα group [6][7] Group 3: Expert Commentary - Professor Huang Lihong stated that the positive data from cohort 4 opens new avenues for functional cure in HBV, emphasizing BRII-179's role in identifying patients who can generate necessary HBsAg antibody responses [3] - Dr. David Margolis highlighted the encouraging results supporting the development of strategies to enrich target populations for chronic HBV functional cure, aiming to improve cure rates for the 254 million chronic HBV patients globally [3]