Brii Bio Delivers First Head-to-Head Comparison of siRNA (Elebsiran) and PEG-IFNα Combination versus PEG-IFNα Alone at AASLD's The Liver Meeting® 2024, Demonstrating Higher Loss of HBV Surface Antigen by Combining with siRNA
Brii Bio announced new data from its Phase 2 ENSURE study, comparing elebsiran (BRII-835) combined with PEG-IFNα versus PEG-IFNα alone in chronic HBV patients. The 48-week end-of-treatment results showed significantly higher HBsAg seroclearance rates in combination therapy groups: 26.3% (200mg elebsiran) and 33.3% (100mg elebsiran) versus 5.6% with PEG-IFNα alone. In patients with baseline HBsAg of 100-1,500 IU/mL, the combination achieved even higher rates: 31.3% (200mg) and 40.0% (100mg). The combination therapy demonstrated greater HBsAg reductions and was generally safe and well-tolerated.
Brii Bio ha annunciato nuovi dati dal suo studio di Fase 2 ENSURE, che confronta elebsiran (BRII-835) combinato con PEG-IFNα rispetto a PEG-IFNα da solo nei pazienti con HBV cronico. I risultati finali a 48 settimane hanno mostrato tassi di seroclearance HBsAg significativamente più alti nei gruppi di terapia combinata: 26,3% (200 mg di elebsiran) e 33,3% (100 mg di elebsiran) rispetto al 5,6% con PEG-IFNα da solo. Nei pazienti con HBsAg basale di 100-1.500 IU/mL, la combinazione ha raggiunto tassi ancora più elevati: 31,3% (200 mg) e 40,0% (100 mg). La terapia combinata ha dimostrato riduzioni maggiori dell'HBsAg ed è stata generalmente sicura e ben tollerata.
Brii Bio anunció nuevos datos de su estudio de Fase 2 ENSURE, que compara elebsiran (BRII-835) combinado con PEG-IFNα frente a PEG-IFNα solo en pacientes con HBV crónico. Los resultados al final de 48 semanas mostraron tasas de seroclearance de HBsAg significativamente más altas en los grupos de terapia combinada: 26,3% (200 mg de elebsiran) y 33,3% (100 mg de elebsiran) frente a 5,6% con PEG-IFNα solo. En pacientes con HBsAg basal de 100-1,500 IU/mL, la combinación logró tasas aún más altas: 31,3% (200 mg) y 40,0% (100 mg). La terapia combinada mostró mayores reducciones en HBsAg y fue generalmente segura y bien tolerada.
Brii Bio는 만성 HBV 환자에서 PEG-IFNα 단독과 비교하여 PEG-IFNα와 결합된 elebsiran (BRII-835)의 2상 ENSURE 연구에서 새로운 데이터를 발표했습니다. 48주 치료 종료 결과, 결합 요법 그룹에서 HBsAg 세로클리어런스 비율이 유의미하게 더 높게 나타났습니다: 26.3% (200mg elebsiran) 및 33.3% (100mg elebsiran), PEG-IFNα 단독의 5.6%에 비해. 기초 HBsAg가 100-1,500 IU/mL인 환자에서는 결합 요법이 더 높은 비율을 달성했습니다: 31.3% (200mg) 및 40.0% (100mg). 결합 요법은 HBsAg 감소에서 더 큰 효과를 보였으며 일반적으로 안전하고 잘 내성되었습니다.
Brii Bio a annoncé de nouvelles données provenant de son étude de phase 2 ENSURE, comparant l'elebsiran (BRII-835) associé au PEG-IFNα par rapport au PEG-IFNα seul chez des patients chroniques atteints d'HBV. Les résultats à la fin du traitement de 48 semaines ont montré des taux de séroclearance HBsAg significativement plus élevés dans les groupes de thérapie combinée : 26,3% (200 mg d'elebsiran) et 33,3% (100 mg d'elebsiran) contre 5,6% avec PEG-IFNα seul. Chez les patients ayant un HBsAg de base compris entre 100 et 1 500 IU/mL, la combinaison a atteint des taux encore plus élevés : 31,3% (200 mg) et 40,0% (100 mg). La thérapie combinée a démontré de plus grandes réductions de l'HBsAg et était généralement sûre et bien tolérée.
Brii Bio hat neue Daten aus seiner Phase-2-Studie ENSURE veröffentlicht, die elebsiran (BRII-835) in Kombination mit PEG-IFNα im Vergleich zu PEG-IFNα allein bei Patienten mit chronischer HBV untersucht. Die 48-wöchigen Ergebnisse am Ende der Behandlung zeigten signifikant höhere HBsAg-Seroclearance-Raten in den Kombinationstherapiegruppen: 26,3% (200 mg elebsiran) und 33,3% (100 mg elebsiran) im Vergleich zu 5,6% mit PEG-IFNα allein. Bei Patienten mit einem Basis-HBsAg von 100-1.500 IU/mL wurden sogar noch höhere Raten erreicht: 31,3% (200 mg) und 40,0% (100 mg). Die Kombinationstherapie zeigte größere HBsAg-Reduktionen und war allgemein sicher und gut verträglich.
- Higher HBsAg seroclearance rates in combination therapy (26.3-33.3%) vs. PEG-IFNα alone (5.6%)
- Superior HBsAg reductions in combination groups (-2.47 to -3.01 log10 IU/mL) vs. control (-1.02 log10 IU/mL)
- Favorable safety and tolerability profile for the combination therapy
- None.
48-week end-of-treatment data from the ongoing Phase 2 ENSURE study clearly demonstrated the added benefits of elebsiran towards achieving a higher functional cure rate in combination with PEG-IFNα
Data from multiple combination studies sponsored by the Company and its partner continue to support the Company's strategy of HBV functional cure in broader patient populations with the right combination regimens
ENSURE is an active-controlled and randomized Phase 2 study designed to evaluate the contribution of elebsiran (BRII-835, VIR-2218), 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. The study excluded HBV patients with low baseline HBsAg levels (<100 IU/mL) to investigate the potential curative benefits in broader patient populations. The ENSURE 48-week end-of-treatment (EOT) data demonstrated that
"The EOT data from the ENSURE study are clearcut," said Dr. Jidong Jia, Professor of Medicine at the Liver Research Centre, Beijing Friendship Hospital, Capital Medical University in
"We are encouraged that the data from this trial continue to support our goal of developing a functional cure for chronic HBV in target populations," said David Margolis, MD, Chief Medical Officer of Brii Bio. "The results highlight the potential of elebsiran as the backbone of combination treatment regimens currently being evaluated in several ongoing trials. We look forward to advancing elebsiran through our ongoing Phase 2 studies in combination with other modalities, aiming to deliver higher functional cure rates to 254 million patients worldwide living with chronic HBV infection."
Abstract Number: 5008
Late-Breaking Oral Presentation Title: Efficacy and safety of elebsiran (BRII-835) and pegylated interferon alpha (PEG-IFNα) combination therapy vs PEG-IFNα in virologically suppressed participants with chronic hepatitis B virus (HBV) infection: preliminary results
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 the sub-population with baseline HBsAg of 100-1,500 IU/mL, HBsAg seroclearance was achieved in
31.3% (5/16) or40.0% (6/15) of participants receiving elebsiran 200 mg or 100 mg in combination with PEG-IFNα, respectively. - 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 rates of HBsAg seroclearance and reductions in HBsAg levels among participants with baseline HBsAg levels 100-3,000 IU/mL.
- 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 elebsiran, tobevibart, an investigational broadly neutralizing monoclonal antibody targeting HBV, and BRII-179, a recombinant protein-based HBV immunotherapeutic. Key data read-outs 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 Elebsiran (BRII-835 or 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 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 and central nervous system 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
[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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FAQ
What were the HBsAg seroclearance rates for elebsiran + PEG-IFNα in the ENSURE study?
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