GSK’s Hepatitis Drug Candidate Shows Promise
In interim results from a mid-stage study, GlaxoSmithKline’s hepatitis drug candidate bepirovirsen showed the potential to suppress both the surface antigen and the virus of hepatitis B after 24 weeks, leading to “the possibility of functional cure,” the company said.
Bepirovirsen is an antisense oligonucleotide that targets the RNA that the hepatitis B virus uses to replicate itself in infected liver cells.
GSK said a phase 3 trial evaluating bepirovirsen as a monotherapy is slated to begin in the first half of 2023. The company is also exploring combinations of bepirovirsen and other therapeutic agents.
Chronic hepatitis B affects nearly 300 million people with approximately 900,000 patients dying each year from its associated complications.
GSK licensed the drug from longstanding partner Ionis as part of a two-drug deal in 2019, paying $25 million upfront with milestone payments taking the value of the deal up to $262 million.
Analysts at William Blair have suggested that the market for an HBV cure could be around the same size as for hepatitis C virus, which peaked at around $10 billion a year but was a short-lived bonanza with sales falling sharply as the pool of eligible patients reduced.
GSK meanwhile has previously suggest that the HBV therapy could collectively achieve sales of more than £2 billion ($2.45 billion) at peak, part of a new wave of therapies that it reckons could add £20 billion to its top-line by 2031.
June 28, 2022