According to the Zhitong Finance APP, BRII-B (02137) announced that at the 34th Annual Meeting of the Asia-Pacific Association for the Study of the Liver (&#34;2025 Asia-Pacific Liver Conference&#34;) held in Beijing, China, the company presented the latest data from its ongoing ENSURE Phase 2 study in the form of an oral report.
ENSURE (NCT05970289) is a multicenter, open-label Phase 2 study. Cohorts 1-3 aim to evaluate the role of elebsiran (an investigational small interfering RNA (siRNA)) in combination with pegylated interferon alpha (&#34;PEG-IFNα&#34;) in treating chronic hepatitis B virus (&#34;HBV&#34;) infected individuals (baseline HBsAg levels of 100-3,000 IU/mL). Participants who received 9 doses of BRII-179 (a recombinant protein-based therapeutic vaccine) in combination with elebsiran (BRII-835) in a previous Asia-Pacific study BRII-179-835-001 (NCT04749368) were included in the 4th cohort of this study and received treatment with elebsiran and PEG-IFNα. The design of this study cohort 4 is based on insights from previous studies indicating that a majority of chronic HBV patients fail to generate sufficient immune responses after multiple doses of BRII-179, making it unlikely for them to achieve immune support for a durable functional cure.
The latest data from cohort 4 show that participants who previously generated BRII-179 induced hepatitis B surface antibody (&#34;anti-HBs&#34;) responses had a significantly higher HBsAg seroclearance rate compared to those who did not respond. At week 24, over half of the BRII-179 responders (55.6% [10/18]) achieved HBsAg seroclearance, while only 10.0% (1/10) of non-responders achieved HBsAg seroclearance. The latest data released indicate that BRII-179 has the potential to serve as a predictive tool for screening patients who are more likely to respond to curative therapies.
Additional data from cohorts 1-3 of the ENSURE study show that participants receiving elebsiran in combination with PEG-IFNα had higher HBsAg clearance rates and seroconversion rates at the end of treatment (&#34;EOT&#34;) compared to those receiving PEG-IFNα monotherapy.
Professor Huang Lihong (Specialist Professor of Gastroenterology and Hepatology at the Medical Data Analysis Center (MDAC) of The Chinese University of Hong Kong and the Department of Medicine and Therapeutics of The Chinese University of Hong Kong) stated: &#34;The positive data from cohort 4 of the ENSURE study opens new doors for functional cure of HBV. Previous studies have indicated that BRII-179 may provide a new pathway for identifying chronic hepatitis B patients who can generate the necessary HBsAg antibody responses. I believe that the latest data provide strong evidence for the value of BRII-179 in screening populations that may benefit from treatment, further establishing BRII-179's position in future combination therapy paradigms.&#34;
The company's Chief Medical Officer, Dr. David Margolis, stated: &#34;The data from the ENSURE study cohort 4 continues to support our enriched strategy for developing functional cures for chronic HBV in the target population, which is very encouraging. The results further highlight the potential of BRII-179 in identifying patients who are more likely to respond to functional cure therapies, as the patient enrichment strategy can improve the functional cure rate in the target population while helping to reduce the treatment cost burden for populations with lower cure probabilities. We are committed to combining BRII-179 with various therapies through ongoing clinical studies and collaborations with strategic partners, aiming to achieve higher functional cure rates for the 254 million chronic HBV-infected patients worldwide.
Report Title: Faster and Higher HBsAg Clearance Achieved by Chronic Hepatitis B Virus Infected Patients Responding to Previous BRII-179 Treatment After Receiving Elebsiran and PEG-IFNα: Preliminary Data from the ENSURE Study
Speaker: Professor Huang Lihong, MBChB(CUHK), MD(CUHK), FRCP(Lond, Edin), FHKCP, FHKAM(Medicine), Professor of Gastroenterology and Hepatology at the Medical Data Analysis Center (MDAC) and the Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong Special Administrative Region
• Among the 31 participants enrolled in cohort 4, 28 participants with baseline HBsAg ≥ 100 IU/mL were included in the analysis. Among them, 18 subjects defined as BRII-179 responders had anti-HBs peaks ≥10 IU/L induced by prior BRII-179 treatment, while 10 subjects defined as non-responders had anti-HBs peaks &lt;10 IU/L.
• At week 24 of elebsiran + PEG-IFNα treatment, 39.3% (11/28) of cohort 4 participants achieved HBsAg seroclearance.
• At week 24, the HBsAg seroclearance rate for BRII-179 responders was 55.6% (10/18), significantly higher than the 10% (1/10) for non-responders.
• Compared to previously reported participants receiving elebsiran + PEG-IFNα treatment without prior BRII-179 treatment, those who previously received BRII-179 treatment appeared to achieve faster HBsAg seroclearance.
• Among chronic HBV-infected participants with virological suppression, the combination of elebsiran and PEG-IFNα treatment was generally safe and well-tolerated.
• Elebsiran + PEG-IFNα treatment will continue for 48 weeks.
Report Title: Higher HBsAg Clearance Rates and Seroconversion Rates at End of Treatment (EOT) in Chronic HBV Infected Patients Receiving Elebsiran and PEG-IFNα Compared to Those Receiving PEG-IFNα Alone: Ongoing ENSURE Study Week 48 Results
Speaker: Professor Jia Jidong, MD, PhD, doctoral supervisor, medical professor at the Liver Disease Research Center of Beijing Friendship Hospital, Capital Medical University, Beijing, China.
• At the end of treatment (EOT), among participants with baseline HBsAg levels of 100-3,000 IU/mL, the HBsAg seroclearance rates for the elebsiran 200 mg + PEG-IFNα cohort and the elebsiran 100 mg + PEG-IFNα cohort were 26.3% (5/19) and 33.3% (6/18), respectively, significantly higher than the PEG-IFNα monotherapy cohort (5.6%).
• Compared to the PEG-IFNα cohort (-1.02 [0.30] log10 IU/mL), the elebsiran + PEG-IFNα cohort showed a greater reduction in HBsAg at EOT (mean [SE]: elebsiran 200 mg or 100 mg were -2.47 [0.28] or -3.01 [0.28] log10 IU/mL, respectively).
• Elebsiran combined with PEG-IFNα treatment (doses of 200 mg and 100 mg, respectively) demonstrated similar effects in terms of HBsAg reduction and seroclearance rates. The elebsiran combined with PEG-IFNα therapy was generally safe and well-tolerated in participants with virologically suppressed chronic HBV infection.
• Post-treatment follow-up is ongoing and will continue until 24 weeks after treatment termination.
As part of the development of unique therapies for functional cure of HBV, the company and its partners are actively advancing multiple combination studies of its differentiated product portfolio, including elebsiran (the company is conducting the elebsiran and PEG-IFNα combination study), tobevibart (an investigational broadly neutralizing monoclonal antibody targeting HBV, with Vir Biotechnology Inc. conducting several phase 2 and phase 3 studies on the tobevibart and elebsiran combination therapy), and BRII-179 (a recombinant protein HBV immunotherapy candidate, with the company conducting studies on the elebsiran and BRII-179 combination therapy). In the coming months of 2025, the company will continue to share key data at major scientific conferences

02137

BRII-B announced the latest data from the ENSURE Phase 2 study at the 2025 Asia-Pacific Association for the Study of the Liver Annual Meeting. The study evaluated the efficacy of elebsiran in combination with PEG-IFNα for the treatment of chronic hepatitis B. The latest data showed that 55.6% of participants receiving BRII-179 achieved HBsAg seroclearance, while only 10% of participants did not respond. This suggests that BRII-179 may become a tool for screening patients with potential response to curative therapies

On the 2025 Asia Liver Conference, BRII-B announced the latest data from its ongoing ENSURE Phase 2 study