Get 40% Off
⚠ Earnings Alert! Which stocks are poised to surge?
See the stocks on our ProPicks radar. These strategies gained 19.7% year-to-date.
Unlock full list

GSK granted US fast track status for chronic hepatits B treatment

Published 12/02/2024, 07:48
Updated 12/02/2024, 07:48
© Reuters.  GSK granted US fast track status for chronic hepatits B treatment

Proactive Investors - GSK (LON:GSK) has been granted US Fast Track designation for bepirovirsen, an investigational treatment for chronic hepatitis B (CHB).

A request was made to US regulator the FDA by the UK pharma due to an unmet medical for what is a serious and life-threatening condition, said the statement.

CHB affects nearly 300 million people worldwide, GSK added and current treatment options offer a less than clinically meaningful 2-8% functional cure rate.

"Bepirovirsen is the only single agent in phase III development that has shown the potential to achieve clinically meaningful functional cure response when combined with oral nucleoside/nucleotide analogues (NAs)," it added.

Explaining, GSK said the treatment inhibits the replication of viral DNA in the body, 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.

Data from phase IIb trials B-Clear and B-Sure in support of the efficacy, safety and durability of the response of bepirovirsen in people with CHB, were submitted with the application.

A confirmatory phase III programme, B-Well, is ongoing.

Bepirovirsen is one of the ASO HBV programme assets in-licensed by GSK from Ionis Pharmaceuticals (NASDAQ:IONS) in August 2019, with the therapy discovered and developed jointly by the two companies.

Read more on Proactive Investors UK

Disclaimer

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.