GSK has submitted a new drug application (NDA) in Japan for bepirovirsen, a first-in-class antisense oligonucleotide (ASO) therapy for chronic hepatitis B (CHB). The company believes the candidate has the potential to be the first therapy to achieve a functional cure for the disease. Bepirovirsen, originally in-licensed from Ionis Pharmaceuticals, is designed to inhibit the replication of hepatitis B virus (HBV) DNA, suppress levels of the hepatitis B surface antigen (HBsAg) and stimulate a durable immune response. It is the first small nucleic acid drug in the CHB field to complete Phase III studies.

The submission is based on positive results from two Phase III trials, B-Well 1 and B-Well 2. Both studies met their primary endpoint, demonstrating that a significantly higher proportion of patients treated with bepirovirsen achieved functional cure compared to those on a placebo. The benefit was more pronounced in patients with lower baseline HBsAg levels. The studies also met all secondary endpoints. If approved, bepirovirsen would represent a significant advancement in the treatment landscape for CHB, a global health burden affecting millions.

PharmCube's NextBiopharm® database shows that GSK committed USD 262 million for bepirovirsen and the similarly acting GSK3389404, although there have been no updates for the latter's developmen in recent years. Click here to request a free trial for NextBiopharm®.