GSK Terminates Hepatitis B Vaccine Trial Due to Efficacy Shortfalls
Trial Termination:
GSK has terminated a Phase 2 trial of a chronic hepatitis B therapeutic vaccine due to failure in meeting efficacy goals14.
Alternative Treatments:
GSK is also developing bepirovirsen, an antisense oligonucleotide for chronic hepatitis B, which has received SENKU designation in Japan and Fast Track designation in the US, indicating potential for expedited review and approval2.
Bepirovirsen Trials:
The B-Clear and B-Sure trials have shown promising results, leading to ongoing Phase III trials (B-Well 1 and B-Well 2) to further assess efficacy and safety2.
Chronic Hepatitis B Impact:
Chronic hepatitis B affects approximately 257 million people worldwide, highlighting the need for effective treatments2.
Regulatory Designations:
The SENKU designation in Japan and Fast Track designation in the US for bepirovirsen underscore the potential of this treatment to address unmet medical needs in chronic hepatitis B management2.
Sources:
1. https://endpts.com/gsk-terminates-phase-2-trial-of-hbv-therapeutic-vaccine/
2. https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-granted-senku-designation-in-japan-for-chronic-hepatitis-b/