GSK’s Bepirovirsen accepted for regulatory review as a potential first in class treatment for chronic hepatitis B

GSK has recently announced that Japan’s Ministry of Health, Labour and Welfare has accepted for review a NDA for bepirovirsen, an investigational antisense oligonucleotide, for the treatment of adults with chronic hepatitis B.

Note that Chronic hepatitis B is a major public health challenge, affecting more than 250 million people worldwide and nearly one million people in Japan. The current standard of care nucleos(t)ide analogues – often requires lifelong therapy and the functional cure rates remain low, typically only 1%.  Functional cure occurs when the hepatitis B virus DNA and viral protein – hepatitis B surface antigen – are at levels low enough to be undetectable in the blood for at least 24 weeks after stopping all treatment, and can be controlled by the immune system without medication.

In addition, the regulatory submission is supported by positive results from the B-Well 1 and B-Well 2 Phase III trials, where bepirovirsen demonstrated a statistically significant and clinically meaningful functional cure rate. Functional cure rates were significantly higher with bepirovirsen plus standard of care compared with standard of care alone across all ranked endpoints, including in patients with lower baseline HBsAg levels where an even greater effect was observed. Bepirovirsen demonstrated an acceptable safety and tolerability profile consistent with previous studies.

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Related Topics and Keywords

bepirovirsen, chronic hepatitis b, GSK