Abstract Title: Impact of various expression systems on efficacy of HBsAg therapeutic vaccines to achieve clearance in a mouse model of chronic hepatitis B The end of study results will be presented today at the American Association for the Study of Liver Diseases’ Liver Meeting 2022 (AASLD) in Washington DC, and simultaneously published in the New England Journal of Medicine. 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.

Data from the phase 2a study will be submitted for publication in a peer-reviewed scientific journal. Based on these data, GSK will progress a phase 2b clinical programme comprising studies called ‘B-Clear’, ‘B-Fine’ and ‘B-Together’ in multiple countries across Europe, Africa, North America and Asia. Phase II trials ongoing to explore potential sequential treatment options with the aim of increasing functional cure rateThe aerosol disinfectant disperses a high-performance disinfectant-Alcohol solution that is suitable for use on all types of surfaces, ideal for areas such as food preparation areas, gyms, offices, homes, trains planes and automobiles. Providing a highly effective sanitisation eradicating the virus even in the hard to get to places. There is a need for therapeutic approaches that enable not only suppression of viral replication, but resolution of chronic HBV infection. About GSK3228836 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: The B-Clear phase IIb trial investigated the efficacy and safety of 12 or 24 weeks of treatment with bepirovirsen in people with CHB on stable NA treatment or not-on-NA treatment at study start. Bepirovirsen, with a loading dose at day 4 and 11, and at a dose of 300mg per week for 24 weeks (treatment arm 1) resulted in 9% of patients on-NA and 10% of patients not-on-NA achieving the primary outcome of HBsAg levels below the Lower Limit of Detection (LLOD) and HBV DNA levels below the Lower Limit of Quantification (LLOQ). Patients with low baseline hepatitis B surface antigen levels 3 responded best to treatment with bepirovirsen in treatment arm 1 with 16% of patients on-NA and 25% of patients not-on-NA achieving the primary outcome.

Four abstracts on linerixibat, an investigational ileal bile acid transporter (IBAT) inhibitor for patients with cholestatic pruritus associated with primary biliary cholangitis (PBC). These include a Decentralized Clinical Trial (DCT) design with the potential to improve patient recruitment and retention in the GLISTEN phase III trial; CONCORD, Mass. & MELBOURNE, Australia--( BUSINESS WIRE)--ClearB Therapeutics, Inc., a company developing a therapeutic vaccine designed to drive functional cure of hepatitis B, announced today that its abstract titled “Impact of various expression systems on efficacy of HBsAg therapeutic vaccines to achieve clearance in a mouse model of chronic hepatitis B” was accepted for poster presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2021, taking place virtually November 12-15, 2021. The phase 2a dose-ranging study investigated GSK’836 at doses of 150mg and 300mg compared to placebo, administered by subcutaneous injection over a four-week treatment period in 31 patients. After the last treatment dose, all patients received tenofovir or entecavir (two available antivirals recommended as first-line monotherapies for chronic hepatitis B) for six months and were observed to determine if HBsAg loss was sustained. Primary endpoints included safety and tolerability. The main efficacy analysis included the change in serum HBsAg and plasma hepatitis B virus DNA from baseline to the end of the 4-week treatment period (Day 29). Other endpoints included additional antiviral parameters and pharmacokinetics. Phase 2a data to be presented at The Digital International Liver Congress suggests potential of investigational drug (GSK3228836) to suppress hepatitis B virus after four weeks of treatment. Chris Stevens holds a BA in chemistry from the University of North Carolina at Chapel Hill, an M.D. degree from the University of Miami in Florida, and attended management classes at the Harvard extension school. He has been an invited speaker to graduating gastroenterology fellows and the Harvard translational medicine course regarding careers in the biopharmaceutical industry. He has over 20 years of biopharmaceutical drug development experience.

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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 under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK’s “Principal risks and uncertainties” section of the Q2 Results and any impacts of the COVID-19 pandemic. CONCORD, Mass.--( BUSINESS WIRE)-- ClearB Therapeutics, Inc., now a clinical-stage biotechnology company committed to developing therapies to drive functional cure in patients with chronic hepatitis B (CHB) infection, announced that the first patient has been dosed in the Phase 1b clinical study evaluating the therapeutic vaccine CLB-3000 ( ACTRN1263000841673). Satisfactory review of safety data for this patient supported opening enrollment for the remainder of the cohort. In the NA-naïve group (n=12), average [SD] reduction reached -1.66 [1.48] log 10 IU/ml vs. placebo 0.00 [0.47], n=6, p<0.001.

CLB-3000 is a bivalent subunit therapeutic vaccine comprised of CLB-405 and CLB-505 proteins, adjuvanted with Alhydrogel®. CLB-405 and CLB-505 were designed to over-represent clearance profile epitopes that were identified from the functional cure patients. The Phase 1b study is an open label dose escalation design enrolling up to 36 CHB patients in as many as 3 cohorts. The objectives of the study are safety, tolerability, and anti-viral activity of CLB-3000. Results from the two ascending dose cohorts are expected in 2H 2024. 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): Using pioneering antisense technology GSK’836 delivered anti-viral activity, marking a potential step forward toward the goal of assessing a functional cure for people with chronic hepatitis B. External scientific engagement on the start of the phase IIb study of GSK4532990 in adults with nonalcoholic steatohepatitis (NASH). 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/companyProfessor Man-Fung Yuen, Principal Investigator and Chief of Division of Gastroenterology and Hepatology, Queen Mary Hospital, The University of Hong Kong, said: “Chronic hepatitis B affects millions of people worldwide and is notoriously difficult to treat. The promising data from the B-Clear study offer the potential for a chance of functional cure for the millions for people who are chronically infected with the virus, particularly for those with low baseline HBsAg levels.” Hepatitis B is a viral infection, caused by the hepatitis B virus (HBV), in the liver that can cause both acute and chronic liver disease. [2] Chronic hepatitis B (CHB) is a long-lasting infection and occurs when the body’s immune system is unable to fight off the virus and it persists in the blood and liver. [3] It is estimated that there are 257 million people globally with CHB. [3] Even when treated, CHB can progress to liver failure and liver cancer, which results in nearly 900,000 deaths per year. [4] Around 22 million people get diagnosed and of these only 1.7 million (8%) get treated. [3]

Phase IIb trial of bepirovirsen in sequential combination with pegylated interferon (PegIFN) treatment; 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. GSK is exploring sequential treatment trials of bepirovirsen with other therapeutic modalities, with the aim of increasing functional cure rate in more patients and reducing the overall burden of CHB. These include: 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.

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He worked at the Victorian Infectious Diseases Reference Laboratory (VIDRL, originally Fairfield Hospital Virus Laboratory) from 1989, as Director of Laboratory Services from 1990 to 1998 and, in 1993, he oversaw the amalgamation of all the Fairfield Laboratories into the one service of the VIDRL. He subsequently assumed the position of Head, Research & Molecular Development of VIDRL when the laboratory relocated to Melbourne Health in 1998.