Across both treatment groups, of the six patients with HBsAg reductions >3.0 log 10 IU/ml, four patients had levels falling below the limit of quantification (0.05 IU/ml). Prolonged HBsAg loss was observed in one-NA treated patient (from Day 36 to Day 113) and one NA-naïve patient (from Day 23 to Day 126). Christopher Corsico, Senior Vice President Development, GSK, said: “Chronic hepatitis B affects around 260 million people globally and, despite existing treatments, can lead to nearly 900,000 deaths per year due to liver failure and liver cancer. We have observed promising early-stage results showing antiviral activity with our anti-sense oligonucleotide, a key investigational medicine in our growing infectious diseases portfolio. This marks a potential step forward toward the goal of assessing sustained functional cure for people with chronic hepatitis B.”

Deleting info from a device will delete it everywhere it's synced. To delete the data from one device without removing it everywhere: For the selected 300mg dose of GSK’836, reductions in HBsAg were observed in NA-treated (HBeAg negative) and NA-naïve patients (HBeAg positive and negative):Professor Locarnini is a past director of the World Health Organisation (WHO) Regional Reference Laboratory for Hepatitis B and D for the Western Pacific Region (WPRO). His current major research interests include viral hepatitis, hepatitis vaccines and antiviral chemotherapy with an emphasis on the basic virology of the various agents of hepatitis, the molecular pathogenesis of hepatitis, as well as prevention and public health control measures. There were no safety signals to preclude further development. AEs leading to treatment discontinuation occurred in 17 participants overall, with 0–4% frequency in participants on-NA, and 0–7% frequency in participants not-on-NA. Serious AEs (SAEs) were reported in 6 (3%) participants on-NA and 11 (5%) participants not-on-NA; 1 SAE in the on-NA and 3 in the not-on-NA population were considered related to treatment. For more information regarding AASLD The Liver Meeting® 2021 please visit https://www.aasld.org/the-liver-meeting Abstract title: A humanized monoclonal antibody 4G2 exhibits anti-viral activity in a mouse model of persistent hepatitis B virus (HBV) infection

We are beyond thrilled to be able to advance our therapeutic vaccine candidate, CLB-3000, toward first in human trials in patients with CHB. We look forward to sharing emerging clinical data with the Hepatitis B community as it becomes available” said Aileen Rubio, PhD, CEO for the company. “CHB infection remains a substantial global health care problem in need of safe and effective therapies. We believe that boosting of patients’ own immune system with ClearB’s therapeutic vaccine, CLB-3000, could become an important component of evolving combination treatment regimens.”

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The World Health Organization defines hepatitis B as a “potentially life-threatening liver infection caused by Hepatitis B virus (HBV). It is a major global health problem. It can cause chronic infection and puts people at high risk of death from cirrhosis and liver cancer.” Approximately 2 billion people are infected with HBV and ~250 million living with CHB. Viral hepatitis is the 7 th ranked cause of human death and liver cancer is the 3 rd most common cause of cancer related death globally. Chronic hepatitis B is a major global health threat that can progress to liver complications including cirrhosis and liver cancer, with approximately 900,000 people dying each year. 1, 2 Functional cure means that the virus is at levels that are low enough to be undetectable in blood and can be controlled by the immune system without medication. Current treatment options have limited success in achieving functional cure. The mainstay of therapy includes nucleoside/nucleotide analogues (NA) which are often taken for life because they suppress but rarely clear the virus. The B-Clear trial consisted of two parallel cohorts, one for patients receiving NA treatment and the other for patients who were not-on-NA. Patients were randomised into 1 of 4 treatment arms within each cohort, with treatment administered weekly with or without loading doses (LD) on days 4 and 11: ClearB Therapeutics was co-founded in 2017 by Morningside Ventures in collaboration with Professor Stephen Locarnini and the Victoria Infectious Diseases Reference Laboratory in Melbourne, Australia. ClearB is working to develop therapeutic vaccines designed to drive functional cure of hepatitis B. The work is grounded in proprietary insights derived from studying rare-event infection resolution in patients who suffer from chronic hepatitis B. For more information, please visit https://clearbtherapeutics.com/.

Chronic hepatitis B is a major global health problem caused by the hepatitis B virus. It is a long-lasting infection that occurs when the body’s immune system is unable to fight off the virus enabling it to persist in the blood and liver. Current treatment options, which include nucleoside/nucleotide analogues, can suppress but not clear the virus, so need to be taken for life. Search history & other Google activity: Searches and other activity on Google services are saved to your Google Account. Learn how to delete Google activity. GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2021, GSK’s Q3 Results for 2022 and any impacts of the COVID-19 pandemic.

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GSK plc (LSE/NYSE: GSK) today announced the publication of positive end of study results from the B-Clear phase IIb trial evaluating the safety and efficacy of bepirovirsen for the treatment of chronic hepatitis B (CHB) in the New England Journal of Medicine. The results showed that treatment with bepirovirsen, an investigational antisense oligonucleotide treatment, resulted in sustained clearance of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA both in patients on concurrent nucleoside/nucleotide analogues (NA) and patients not-on-NA therapy. In NA-treated group (n=4), a numerically greater average [SD] reduction of -2.51 [1.57] log 10 IU/ml vs. placebo -0.01 [0.04], n=2, p=0.45 was observed. Three of these patients had reductions ≥3.0 log 10 IU/mL by Day 29. One additional patient discontinued at day 4 and was not included in the analysis. Chris Corsico, SVP, Development, GSK, said: “Today’s results from the B-Clear study are a promising step forward for the approximately 300 million people living with chronic hepatitis B. We look forward to confirming these findings for bepirovirsen in our phase III study starting next year, as well as exploring potential sequential therapy options with the aim of helping more people living with CHB achieve functional cure.” GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com/company

We are also excited to continue to showcase new preclinical data on an additional novel immune based serotherapy approach at the upcoming AASLD The Liver Meeting,” Dr. Rubio added. For more information regarding AASLD The Liver Meeting 2023, please visit The Liver Meeting | AASLD.In addition to the full study results for the B-Clear trial, GSK will share updates on its specialty and vaccines pipeline at the AASLD meeting in Washington DC, including: Abstract Title : Therapeutic vaccination with CLB-3000 in a mouse model of chronic Hepatitis B induces anti-HBs responses associated with functional cure There is a need to develop new treatments that provide a longer-lasting solution. GSK’836 uses established antisense oligonucleotide technology to suppress the virus and the viral proteins with the goal of assessing functional cure, the greatest unmet medical need in treating chronic hepatitis B. Functional cure is when the virus is not completely eliminated but is at low levels that can be controlled by the immune system without medication. It is largely defined as sustained, undetectable levels of hepatitis B virus DNA and HBsAg (surrogate markers of chronic hepatitis B) in the blood with or without generating protective antibodies after a finite course of treatment. Phase IIb trial of bepirovirsen in sequential combination with pegylated interferon (PegIFN) treatment;