GSK 3228836 enters 2 Phase III B-Well trials for hepatitis B
Ionis Pharmaceuticals announced that GSK has initiated two randomized, double-blind, placebo-controlled Phase III studies evaluating the safety and efficacy of GSK 3228836 (bepirovirsen) (formerly IONIS-HBVRx), an investigational antisense medicine for the treatment of patients with chronic hepatitis B infection (CHB)
They are: Phase III Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1) and Phase III Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2).
B-Well 1 is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: Double-blind treatment (bepirovirsen or placebo) for 24 weeks; Nucleos(t)ide analogue (NA) treatment for 24 weeks; NA cessation with 24 week follow up OR Continue NA for 24 weeks, follow up for further 24 weeks for participants who stopped NA treatment at Week 48.
B-Well 2 is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: Double-blind treatment (bepirovirsen or placebo) for 24 weeks; Nucleos(t)ide analogue (NA) treatment for 24 weeks; NA cessation with 24 week follow up OR Continue NA for 24 weeks, follow up for further 24 weeks for participants who stopped NA treatment at Week 48.