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(Sharecast News) - GSK said on Thursday that late-stage trial results for its experimental drug for chronic hepatitis B, bepirovirsen, showed that it helped nearly one in five patients to achieve a functional cure.
Bepirovirsen is an investigational antisense oligonucleotide (ASO) designed to recognise and inhibit the production of the genetic components (i.e. RNA) of the hepatitis B virus that can lead to chronic disease, potentially allowing a person's immune system to regain control.
Bepirovirsen reduces the production of RNA and viral proteins associated with HBV, suppresses the level of hepatitis B surface antigen (HBsAg) in the blood, and stimulates the immune system to increase the chances of a durable and sustained response.
GSK said that pooled data from two Phase 3 trials revealed that after a six-month treatment, bepirovirsen achieved a statistically significant and clinically meaningful 19% functional cure response rate in the overall study population, meeting the primary endpoints.
Functional cure occurs when the hepatitis B virus DNA and hepatitis B surface antigen (HBsAg) are undetectable in the blood for at least six months after stopping all treatment. This indicates the disease is controlled by the immune system without medication.
Chief scientific officer Tony Wood said: "Chronic hepatitis B affects over 240 million people worldwide and accounts for over half of global liver cancer cases. For the first time, bepirovirsen offers the possibility of significantly better functional cure rates than the current standard of care, and the potential to reduce the risk of long-term liver complications, including cancer. This is a major step forward in our growing pipeline to treat liver disease to help transform outcomes for patients."
At 1418 BST, the shares were down 0.8% at 1,924p.
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