GSK hails promising trial results for hepatitis B treatment
Drug could provide a cure for condition that affects more than 250mn people
GSK’s treatment for chronic hepatitis B delivered a positive result in two late-stage trials and could provide a cure for a condition that affects more than 250mn people.
The British drugmaker said on Wednesday that its phase 3 trials of bepirovirsen delivered a “statistically significant and clinically meaningful functional cure rate” in the more than 1,800 patients from 29 countries who participated in the two studies.
Functional cure rates, defined as when the virus can no longer be detected in patients’ blood, were significantly higher with bepirovirsen plus standard of care, compared with standard of care alone, the company said.
The current standard of care for the viral disease, which is the leading cause of liver cancer and can lead to serious liver damage, involves life-long treatment using antiviral drugs that stop virus replication.
UBS analyst Colin White said in a note he forecast that the drug would reach peak annual sales of $2bn.
The clinical trial success of bepirovirsen, which will be submitted to regulatory agencies for approval, could be a boon for GSK. Its performance has lagged peers in recent years and is searching for new blockbuster drugs to replenish its pipeline.
Many of the FTSE 100 group’s bestsellers, especially several HIV medications with the compound dolutegravir, will lose US and European exclusivity between 2028 and 2030.
Shares dipped 1 per cent in morning trading but have risen nearly 40 per cent over the past 12 months, valuing the company at almost £77bn.
GSK, which has an ambitious goal of increasing revenues from £31bn in 2024 to £40bn by 2031, received regulatory approval last year for several potential blockbuster drugs including exdensur, an asthma drug with peak annual sales potential of £3bn.
The news marks an early win for chief executive Luke Miels, who has taken over from Dame Emma Walmsley and has said he stood by the £40bn forecast.
Tony Wood, GSK’s chief scientific officer, said: “Today’s result supports our plans to progress bepirovirsen as a treatment and also continue its development as a backbone in future sequential therapies. We’re pleased by this major advance in our expanding hepatology pipeline, aimed to transform outcomes in liver disease.”