GSK reveals positive but lackluster data from the Ph2b B-Together study (bepirovirsen + pegIFN) in AASLD 2023 abstract
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AASLD 2023 abstracts were released on October 10th, 2023.
GSK presents an oral abstract that will highlight results from the Ph2b B-Together study (bepirovirsen + pegIFN, N=108).
Key Highlights of the Oral Abstract
- The Ph2b B-Together study (N=108) was an open label study where patients received 300mg of bepirovirsen (bepi) (SC Q1W) for 12 wks or 24 wks and then received pegIFN for 24 wks
- Serious adverse events were experienced by 8 pts (7%), however no new safety signals were observed for bepi
- Efficacy results were:
CI Assessment
- This is the first look of bepi activity in combination with another component required for potential functional cure of 30%
- Data from this study demonstrates lackluster functional cure rates and limited additive benefit of pegIFN when compared to results from B-CLEAR bepi monotherapy study, which demonstrated ~9% functional cure rate
- Recall, VIR-2218 + peg-IFN demonstrated a SVR24 was 16.1% (5/31)
- This data supports the notion that ASOs in combination therapies can achieve a durable response in HBV but addition of a third component is likely needed
- GSK is currently conducting a Ph2b study evaluating bepi in combination with a vaccine (N=184); data from this study is expected to readout in H1 2026
- GSK is the only competitor in HBVCure who has all three components to potentially achieve functional cure, however, GSK is yet to initiate a clinical trial with three components
- If GSK continues to develop the bepi + pegIFN combination, an approval as early as 2028 would be possible following the successful completion of a Ph3 study
- If bepi monotherapy is approved (~2026), bepi could be combined with Peg-IFN off-label before approval of the combo
In addition to this abstract, GSK will also present 8 other abstracts for HBV including 2 post-hoc analyses from Ph2b B-Together study. The post-hoc analyses explore the responses of different HBV genotypes to bepi + pegIFN and mechanistic PK/PD modelling and simulation to inform Ph3 study design. More details on the HBV abstracts from GSK can be found in the table below.
HBV portfolio
Component |
Molecule and MOA |
Phase of study of monotherapy |
RNA interference molecule |
Bepirovirsen/GSK3228836 (Antisense oligonucleotide) |
|
Vaccine |
GSK3528869A (therapeutic viral vaccine with adjuvanted recombinant protein) |
|
Immune modulator |
GSK5251738 (TLR8 Agonist) |
Ph1 (Study conducted by Shanghai Zhimeng Biopharma) |
Other GSK HBV studies:
Study name |
Combinations of interest |
Phase |
Enrollment |
Data Readout |
Potential Approval | Comments |
B-WELL 1 B-WELL 2 |
ASO monotherapy |
2 x 900 |
2H 2025 |
Mid-2026 |
|
|
B-TOGETHER |
ASO + Peg-IFNα + NUC |
108 |
2H 2023 |
H1 2028 |
|
|
- |
ASO + VAX + NUC |
184 |
1H 2026 |
H1 2031 |
|
|
B-FINE |
ASO monotherapy |
20 |
Q1 2024 |
- |
Study includes repeat fine needle aspirations of the liver for intrahepatic immunophenotyping |
|
B-SURE |
ASO monotherapy |
450 |
Q2 2026 |
- |
Long-term follow-up study to assess durability of SVR in bepirovirsen-treated patients; Initial data presented at EASL 2023 |
|
B-ASSURED |
ASO monotherapy |
24 |
2H 2023 |
- |
Investigates pharmacokinetics in cirrhotic patients |
|
- |
ASO + PAPD5/PAPD7 inhibitor |
132 |
1H 2026 |
Beyond 2032 |
PAPD5/7 inhibitors demonstrate neurotoxicity in patients |