GSK enters agreement to obtain exclusive license for hepatitis B therapy to expand bepirovirsen development
GSK will be responsible for upfront and potential milestone-based payments to both Janssen and Arrowhead totalling approximately USD 1 billion.;
London: GSK plc and Arrowhead Pharmaceuticals Inc. have announced that they have reached an agreement with Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, to transfer exclusive worldwide rights to further develop and commercialise JNJ-3989 to GSK. JNJ-3989 (formerly ARO-HBV) was initially in-licensed by Janssen from Arrowhead in 2018.
JNJ-3989 is an investigational hepatitis B virus-targeted small interfering ribonucleic acid (siRNA) therapeutic that GSK intends to evaluate in a sequential regimen with bepirovirsen, GSK’s investigational antisense oligonucleotide, for the treatment of adult non-cirrhotic patients with chronic hepatitis B (CHB) on nucleos(t)ide analogue (NA) therapy.
There is high unmet need in CHB with an estimated 300 million people living with the disease and a less than 3-7% functional cure rate with current treatment options. Patients reach functional cure when the hepatitis B virus and viral proteins are at levels low enough to be undetectable in blood and can be controlled by the immune system without medication.
Bepirovirsen is the only single agent in phase III development that has shown clinically meaningful functional cure response for patients with CHB receiving oral NAs, following positive results demonstrated in the B-Clear and B-Sure clinical trials. B-Clear identified sub-groups of patients most likely to benefit from treatment with bepirovirsen, and also solidified bepirovirsen as a potential backbone therapy in future sequential regimens to pursue functional cure in additional patients with CHB.
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