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
Brii Bio (BRIBY) has unveiled new data from its ongoing Phase 2 ENSURE study at APASL 2025, highlighting promising results in treating chronic HBV infection. The study's Cohort 4 data revealed that participants who previously responded to BRII-179 (therapeutic vaccine) achieved a 55.6% HBsAg seroclearance rate at Week 24, compared to only 10% in non-responders.
The 48-week data from Cohorts 1-3 demonstrated that the combination of elebsiran (siRNA) with PEG-IFNα achieved higher HBsAg loss rates of 26.3% (200mg) and 33.3% (100mg), significantly outperforming PEG-IFNα alone (5.6%). The combination therapy showed greater HBsAg reductions and was generally well-tolerated.
This data supports BRII-179's potential as a predictive tool for identifying patients more likely to respond to curative therapies, potentially improving treatment efficiency for the 254 million patients worldwide living with chronic HBV infection.
Brii Bio (BRIBY) ha rivelato nuovi dati dal suo studio di fase 2 ENSURE all'APASL 2025, evidenziando risultati promettenti nel trattamento dell'infezione cronica da HBV. I dati del Coorte 4 hanno rivelato che i partecipanti che avevano precedentemente risposto a BRII-179 (vaccino terapeutico) hanno raggiunto un tasso di seroclearance HBsAg del 55,6% alla settimana 24, rispetto al solo 10% nei non rispondenti.
I dati a 48 settimane dei Coorti 1-3 hanno dimostrato che la combinazione di elebsiran (siRNA) con PEG-IFNα ha raggiunto tassi di perdita di HBsAg più elevati del 26,3% (200mg) e del 33,3% (100mg), superando significativamente PEG-IFNα da solo (5,6%). La terapia combinata ha mostrato maggiori riduzioni di HBsAg ed è stata generalmente ben tollerata.
Questi dati supportano il potenziale di BRII-179 come strumento predittivo per identificare i pazienti più propensi a rispondere a terapie curative, migliorando potenzialmente l'efficienza del trattamento per i 254 milioni di pazienti nel mondo che vivono con infezione cronica da HBV.
Brii Bio (BRIBY) ha revelado nuevos datos de su estudio de fase 2 ENSURE en APASL 2025, destacando resultados prometedores en el tratamiento de la infección crónica por HBV. Los datos del Cohorte 4 revelaron que los participantes que previamente respondieron a BRII-179 (vacuna terapéutica) lograron una tasa de seroclearance de HBsAg del 55,6% a la semana 24, en comparación con solo el 10% en los no respondedores.
Los datos de 48 semanas de los Cohortes 1-3 demostraron que la combinación de elebsiran (siRNA) con PEG-IFNα logró tasas de pérdida de HBsAg más altas del 26,3% (200mg) y del 33,3% (100mg), superando significativamente a PEG-IFNα solo (5,6%). La terapia combinada mostró mayores reducciones de HBsAg y fue generalmente bien tolerada.
Estos datos respaldan el potencial de BRII-179 como herramienta predictiva para identificar a los pacientes que tienen más probabilidades de responder a terapias curativas, lo que podría mejorar la eficiencia del tratamiento para los 254 millones de pacientes en todo el mundo que viven con infección crónica por HBV.
Brii Bio (BRIBY)는 APASL 2025에서 진행 중인 2상 ENSURE 연구의 새로운 데이터를 공개하며 만성 HBV 감염 치료에서 유망한 결과를 강조했습니다. 4군의 데이터에 따르면, BRII-179(치료 백신)에 이전에 반응한 참가자들은 24주 차에 HBsAg 세로클리어런스 비율이 55.6%에 도달했으며, 비반응자에서는 단 10%에 불과했습니다.
1-3군의 48주 데이터는 elebsiran (siRNA)과 PEG-IFNα의 조합이 각각 26.3% (200mg) 및 33.3% (100mg)의 더 높은 HBsAg 손실 비율을 달성했으며, PEG-IFNα 단독(5.6%)보다 유의미하게 성과를 냈습니다. 이 조합 요법은 HBsAg 감소가 더 컸으며 일반적으로 잘 견뎌졌습니다.
이 데이터는 BRII-179가 치료 가능한 요법에 더 잘 반응할 가능성이 있는 환자를 식별하는 예측 도구로서의 잠재력을 지원하며, 이는 전 세계 2억 5천4백만 명의 만성 HBV 감염 환자에 대한 치료 효율성을 향상시킬 수 있습니다.
Brii Bio (BRIBY) a dévoilé de nouvelles données de son étude de phase 2 ENSURE lors de l'APASL 2025, mettant en évidence des résultats prometteurs dans le traitement de l'infection chronique par le VHB. Les données de la Cohorte 4 ont révélé que les participants ayant précédemment répondu à BRII-179 (vaccin thérapeutique) ont atteint un taux de séroclearance HBsAg de 55,6 % à la semaine 24, contre seulement 10 % chez les non-répondeurs.
Les données de 48 semaines des Cohortes 1-3 ont démontré que la combinaison d'elebsiran (siRNA) avec PEG-IFNα a atteint des taux de perte de HBsAg plus élevés de 26,3 % (200 mg) et de 33,3 % (100 mg), dépassant de manière significative PEG-IFNα seul (5,6 %). La thérapie combinée a montré des réductions de HBsAg plus importantes et a été généralement bien tolérée.
Ces données soutiennent le potentiel de BRII-179 en tant qu'outil prédictif pour identifier les patients les plus susceptibles de répondre aux thérapies curatives, ce qui pourrait améliorer l'efficacité du traitement pour les 254 millions de patients dans le monde vivant avec une infection chronique par le VHB.
Brii Bio (BRIBY) hat auf der APASL 2025 neue Daten aus seiner laufenden Phase-2-Studie ENSURE vorgestellt, die vielversprechende Ergebnisse bei der Behandlung von chronischen HBV-Infektionen hervorheben. Die Daten der Kohorte 4 zeigten, dass Teilnehmer, die zuvor auf BRII-179 (therapeutischer Impfstoff) angesprochen hatten, eine HBsAg-Seroclearance-Rate von 55,6 % nach 24 Wochen erreichten, im Vergleich zu nur 10 % bei Nicht-Responders.
Die 48-Wochen-Daten der Kohorten 1-3 zeigten, dass die Kombination von elebsiran (siRNA) mit PEG-IFNα höhere HBsAg-Verlustraten von 26,3 % (200 mg) und 33,3 % (100 mg) erreichte und PEG-IFNα allein (5,6 %) signifikant übertraf. Die Kombinationstherapie zeigte größere HBsAg-Reduktionen und wurde im Allgemeinen gut vertragen.
Diese Daten unterstützen das Potenzial von BRII-179 als prädiktives Werkzeug zur Identifizierung von Patienten, die wahrscheinlich besser auf heilende Therapien ansprechen, was potenziell die Behandlungseffizienz für die 254 Millionen Patienten weltweit mit chronischer HBV-Infektion verbessern könnte.
- 55.6% HBsAg seroclearance rate in BRII-179 responders vs 10% in non-responders
- Higher EOT HBsAg loss rates with elebsiran + PEG-IFNα (26.3-33.3%) vs PEG-IFNα alone (5.6%)
- Significant HBsAg reductions in combination therapy (-2.47 to -3.01 log10 IU/mL)
- Both 100mg and 200mg elebsiran doses showed similar efficacy
- Therapy demonstrated good safety and tolerability profile
- 44.4% of BRII-179 responders still did not achieve HBsAg seroclearance
- Significant proportion of patients fail to generate sufficient immune response to BRII-179
- Treatment requires long-term administration (48 weeks)
- 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 EOT
- 48-week EOT data from Cohort 1-3 of the ENSURE study clearly suggests the added benefits of elebsiran towards achieving a higher rate of HBsAg loss in combination with PEG-IFNα
DURHAM, N.C. and
ENSURE (NCT05970289) is a multicenter, open-label Phase 2 study. Cohorts 1-3 were designed to evaluate the contribution of elebsiran, an investigational small interfering ribonucleic acid (siRNA), in combination with pegylated interferon alpha (PEG-IFNα) in participants with chronic HBV infection with baseline hepatitis B surface antigen (HBsAg) of 100-3,000 IU/mL. Participants who completed 9 doses of BRII-179, a recombinant protein-based therapeutic vaccine, in combination with elebsiran (BRII-835) in a previous APAC study BRII-179-835-001 (NCT04749368) were enrolled to Cohort 4 of this study and received elebsiran and PEG-IFNα combination treatment. The design of Cohort 4 as part of this study was based on insight from previous studies that a significant proportion of the chronic HBV patients fail to generate a sufficient immune response after receiving multiple doses of BRII-179, and therefore unlikely to have the immune support to achieve sustainable functional cure.
Emerging data from Cohort 4 showed that participants who previously had BRII-179 induced anti-HBs response achieved a substantially higher rate of HBsAg seroclearance than those who did not. At Week 24, more than half of the BRII-179 responders (
Additional data from Cohorts 1-3 of the ENSURE study showed that higher end of treatment (EOT) HBsAg loss and seroconversion rates in participants receiving elebsiran in combination with PEG-IFNα than those receiving PEG-IFNα alone.
"The positive Cohort 4 data from the ENSURE study opens new doors for HBV functional cure," said Dr. Grace Lai-Hung Wong, Professor of Gastroenterology and Hepatology at CUHK Medical Data Analytics Centre (MDAC) and Department of Medicine and Therapeutics in
"We are encouraged that the Cohort 4 from the ENSURE study continue to support our enrichment strategy in developing a functional cure for chronic HBV in target populations," said David Margolis, MD, Chief Medical Officer of Brii Bio. "The results underscore the potential of BRII-179 in identifying patients who are more likely to respond to regimens aimed at functional cure, thereby enhancing functional cure rates in the target population while reducing exposure to costly therapies for those with a lower probability of cure. We are committed to advancing BRII-179 in combination with various modalities through our ongoing studies and collaborations with strategic partners, aiming to deliver higher functional cure rates to 254 million patients worldwide living with chronic HBV infection."
Abstract Number: OP0335
Presentation Title: Responders to Prior BRII-179 Treatment Achieved Faster and Higher Rate of HBsAg Seroclearance Following Treatment of Elebsiran and PEG-IFNα in Participants with Chronic Hepatitis B Virus Infection: Preliminary Data from ENSURE Study
Presenter: Grace Lai-Hung Wong, MBChB (CUHK), MD (CUHK), FRCP (Lond, Edin), FHKCP, FHKAM (Medicine), Professor of Gastroenterology and Hepatology at CUHK Medical Data Analytics Centre (MDAC) and Department of Medicine and Therapeutics in Hong Kong SAR,
- Among the 28 of the 31 participants enrolled in Cohort 4 with baseline HBsAg ≥ 100 IU/mL being analyzed, 18 participants with peak anti-HBs ≥ 10 IU/L induced by prior BRII-179 treatment were defined as BRII-179 responders and 10 participants with peak anti-HBs < 10 IU/L were defined as non-responders.
- At Week 24 of treatment with elebsiran + PEG-IFNα,
39.3% (11/28) of the Cohort 4 participants achieved HBsAg seroclearance. - The rate of HBsAg seroclearance at Week 24 in the BRII-179 responders was
55.6% (10/18), notably higher compared to the non-responders at10% (1/10). - Responders to prior BRII-179 treatment appeared to achieve a faster HBsAg seroclearance compared to BRII-179 naïve participants receiving elebsiran + PEG-IFNα as previously reported.
- Elebsiran and PEG-IFNα combination therapy was generally safe and well tolerated in participants with virally suppressed chronic HBV infection.
- Treatment with elebsiran + PEG-IFNα is ongoing for 48 weeks.
Abstract Number: LB0009
Presentation Title: Higher end of treatment (EOT) HBsAg loss and seroconversion rates in participants with chronic HBV infection receiving elebsiran (BRII-835) and pegylated interferon alfa-2a (PEG-IFNα) compared to PEG-IFNα alone: Week 48 results from ongoing ENSURE study
Presenter: Jidong Jia, M.D., Ph.D., Professor of Medicine at the Liver Research Centre, Beijing Friendship Hospital, Capital Medical University in
- The rates of HBsAg seroclearance at EOT in elebsiran 200 mg + PEG-IFNα and elebsiran 100 mg + PEG-IFNα cohorts were
26.3% (5/19) and33.3% (6/18), respectively, notably higher compared to PEG-IFNα alone cohort (5.6% ) in participants with baseline HBsAg levels 100-3,000 IU/mL. - Greater HBsAg reductions at EOT were observed in elebsiran + PEG-IFNα combination cohorts (mean [SE]: -2.47 [0.28] or -3.01 [0.28] log10 IU/mL in elebsiran 200 mg or 100 mg, respectively) than in PEG-IFNα cohort (-1.02 [0.30] log10 IU/mL).
- Elebsiran in combination with PEG-IFNα at both 200 mg and 100 mg doses achieved similar HBsAg reductions and seroclearance rates. Elebsiran and PEG-IFNα combination therapy was generally safe and well tolerated in participants with virally suppressed chronic HBV infection.
- Post-treatment follow-up is ongoing and will continue for 24 weeks after discontinuation of treatment.
As part of Brii Bio's unique approach to developing a functional cure for HBV, the Company and its partners are actively progressing multiple combination studies with our differentiated portfolio, including BRII-179, a recombinant protein-based HBV immunotherapeutic being evaluated in multiple combination studies with elebsiran led by Brii Bio; elebsiran being evaluated in combination with PEG-IFNα in studies led by Brii Bio and tobevibart, an investigational broadly neutralizing monoclonal antibody targeting HBV, being evaluated in multiple Phase 2 and 3 tobevibart and elebsiran combination studies led by Vir Biotechnology. Key data readouts will be shared in the coming months at the scientific conferences throughout 2025.
About Hepatitis B
Hepatitis B virus (HBV) infection is one of the world's most significant infectious disease threats with more than 254 million people infected globally.[1] Chronic HBV infection is the leading cause of liver disease and an estimated 820,000 people die of complications from chronic HBV infection each year.[1] HBV is of exceptional concern in
About BRII-179
BRII-179 is a novel recombinant protein-based HBV immunotherapeutic candidate that expresses the Pre-S1, Pre-S2, and S HBV surface antigens, and is designed to induce enhanced and broad B-cell and T-cell immunity. In November 2023, the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration (the "NMPA") granted BRII-179 Breakthrough Therapy Designation.
About Elebsiran (BRII-835, VIR-2218)
Elebsiran is an investigational subcutaneously administered HBV-targeting siRNA designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. It has the potential to have direct antiviral activity against HBV and HDV. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus technology to enhance stability and minimize off-target activity, which potentially can result in an increased therapeutic index. Brii Bio licensed exclusive rights to develop and commercialize elebsiran for the Greater China territory from Vir Biotechnology, Inc. in 2020.
About Brii Bio
Brii Biosciences Limited ("Brii Bio", stock code: 2137.HK) is a biotechnology company developing therapies to address major public health challenges where patients experience high unmet medical needs, limited choice and significant social stigmas. With a focus on infectious diseases, the Company is advancing a broad pipeline of unique therapeutic candidates with lead programs against hepatitis B virus (HBV) infection. The Company is led by a visionary and experienced leadership team and has operations in key biotech hubs, including Raleigh-Durham, the
[1] World Health Organization. (April 2024). Global hepatitis report 2024: action for access in low- and middle-income countries. World Health Organization. Retrieved from https://www.who.int/publications/i/item/9789240091672 |
[2] World Health Organization. Hepatitis. World Health Organization. Retrieved from https://www.who.int/china/health-topics/hepatitis#:~:text=There%20are% |
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