Drug intelligence / Profile preview

GSK3965193 + bepirovirsen

Development stage
Unknown
Lead developer
GSK
Modality
Small Molecules, Antisense Oligonucleotides (ASOs) → Long RNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Modified DNA Oligonucleotides → Antisense DNA → DNA Therapeutics → Nucleic Acid Therapeutics, Single-strand DNA → Antisense DNA → DNA Therapeutics → Nucleic Acid Therapeutics
Administration
Oral (GSK3965193), Subcutaneous (bepirovirsen)
01

Overview

GSK3965193 + bepirovirsen is an investigational combination therapy composed of two agents in clinical development for the treatment of chronic hepatitis B infection. **GSK3965193** is an oral agent with a novel mechanism targeting hepatitis B surface antigen (HBsAg) reduction, though its precise molecular target remains undisclosed. **Bepirovirsen** is an antisense oligonucleotide designed to bind to hepatitis B virus (HBV) messenger RNAs, thereby reducing synthesis of all HBV proteins including HBsAg. The rationale for the combination is to achieve a sustained functional cure of chronic hepatitis B by simultaneously reducing circulating viral proteins and stimulating immune control. Both agents have demonstrated the ability to lower HBsAg: GSK3965193 in preclinical and early clinical studies and bepirovirsen in phase II/III trials. Combination studies are currently in early-phase evaluation to assess safety, tolerability, and preliminary efficacy in people living with chronic hepatitis B, with the goal of achieving higher functional cure rates than monotherapy[1][3][7].

Other names
bepirovirsen + GSK3965193
02

Targets

HBV RNA (Hepatitis B virus RNA)

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