Reshaping the HIV treatment and prevention landscape
HBV ASO ('836): potential FiC 'functional cure' for Chronic HBV
Significant unmet need for functional cure
--2bn people infected with Hepatitis B virus but diagnosis
rates low (<9% globally)
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~250m people living with Chronic Hep B (CHB)
~900k people die from CHB annually
SoC suppresses viral replication, does not eliminate HBV
antigen production
GSK goal to clear HBV surface antigen with defined
treatment period to achieve 'functional cure'
Global opportunity >£2bn
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China ~1/3 of global patients; new GSK leadership and
capabilities support competitive opportunity
- US/Europe patient size similar to HepC market
gsk
Phase 2b study of GSK'836 ongoing with focus
on eliminating HBsAg
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ASOS designed to bind precisely with RNA, halting process of
creating new virus and immune tolerance proteins
Phase 2a data* (EASL 2020) showed significant reductions in
HBsAg in both untreated patients and patients on SoC
Log10 change (HBsAg)
0
-1
-2
-3
-4
-5
300 mg
300 mg
Placebo
150 mg
nuc suppressed
ཀ
Each patient
*
*
*
*
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Data from Phase 2b study vs SoC expected in 2022
*
- <LLOQ
SoC Standard of Care; ASO Antisense oligonucleotide; FiC First-in-Class; *Open Circles - Day 29, Columns - Nadir,
Functional cure is when the virus is not completely eliminated but is at low levels that can be controlled by the immune system without medication. It is largely defined as sustained, undetectable levels of hepatitis B virus DNA and HBsAg
(surrogate markers of chronic hepatitis B) in the blood with or without generating protective antibodies after a finite course of treatment.
1. Yuen et al, EASL 2020
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