GSK’s potential “functional cure” for hepatitis B drug has proven its worth in a pair of hotly anticipated phase 3 studies, setting up the pharma for a push to the FDA.
The British drugmaker had been evaluating the Ionis Pharmaceuticals-partnered antisense oligonucleotide, called bepirovirsen, in a pair of late-stage studies for chronic hepatitis B (CHB) spanning more than 1,800 patients in 29 countries.
The trials, dubbed B-Well 1 and B-Well 2, met their primary endpoints by demonstrating a statistically significant and clinically meaningful higher functional cure rate for bepirovirsen and the current standard of care of nucleos(t)ide analogues versus standard of care alone among patients with baseline hepatitis B surface antigen (HBsAg) of less than 3,000 IU/ml.
“Functional cure” in the context of the studies was defined as HBsAg loss and undetectable HBV DNA for at least 24 weeks after the treatment.
The results were statistically significant across all ranked endpoints, explained GSK, which singled out patients with HBsAg below 1,000 IU/ml, where “an even greater effect was demonstrated.”
“The studies demonstrated an acceptable safety and tolerability profile consistent with what was reported in other studies,” the pharma noted.
GSK is holding back the detailed data for an upcoming conference but said it is planning an approval push to regulators in the first quarter of this year.
If successful, bepirovirsen—which the pharma licensed from Ionis for $25 million upfront in 2019—could become the “first finite, six-month therapeutic option for CHB and to serve as a backbone for future sequential treatment strategies,” the company said.
“Bepirovirsen has the potential to transform treatment goals for people living with CHB by achieving significant functional cure rates—a first for the disease,” GSK Chief Scientific Officer Tony Wood, Ph.D., said in a statement.
“CHB affects more than 250 million people and leads to approximately 56% of liver cancer cases worldwide,” Wood added. “Today’s result supports our plans to progress bepirovirsen as a treatment and also continue its development as a backbone in future sequential therapies.”
Ionis CEO Brett Monia, Ph.D., said bepirovirsen was “uniquely positioned to effectively treat CHB based on its potential to reduce the replication of hepatitis B virus, suppress hepatitis B surface antigen and stimulate the immune system.”
GSK had been working on another functional cure for hepatitis B in the form of the therapeutic vaccine GSK3528869, before scrapping that program a year ago over unimpressive data. The company also has a number of other assets in clinical development for CHB, including the hepatitis B virus-targeted siRNA GSK5637608, the PAPD5/PAPD7 inhibitor GSK3965193 and the TLR8 agonist GSK5251738.
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