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These data from the 31 patients participating in the phase 2a study will be virtually presented at The Digital International Liver Congress (ILC) 2020. [1] 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. Yuen MF et al. Hepatitis B virus (HBV) surface antigen (HBsAg) inhibition with ISIS 505358 in chronic hepatitis B (CHB) patients on stable nucleos(t)ide analogue (NA) regimen and in NA -naive CHB patients: phase 2a, randomized, double-blind, placebo-controlled study. Abstract No. AS067. The Digital International Liver Congress 2020.
Professor 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.” 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. Professor Man-Fung Yuen, Principal Investigator and Chief of Division of Gastroenterology and Hepatology, Queen Mary Hospital, The University of Hong Kong, said: “The goal to achieve functional cure at an early age would potentially have a lower risk of liver-related complications and liver cancer. In addition, enhanced immune control associated with functional cure would potentially allow patients to be free of long-term medications. The promising results of this early-phase study warrant further investigation in efforts to achieve this goal.” Deleting info from a device will delete it everywhere it's synced. To delete the data from one device without removing it everywhere:The b-clear anti-viral sanitiser is scientifically proven to be effective at eradicating Coronavirus. 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. 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.
Bepirovirsen is an investigational antisense oligonucleotide (ASO) designed to specifically recognise the RNA that the hepatitis B virus uses to replicate itself in the infected liver cells (hepatocytes) and make the viral antigens (proteins) which facilitate chronicity of the disease by helping to avoid clearance by the immune system. The ASO recruits the liver’s own enzymes to eliminate the RNA by digesting it to an inactive form. The subsequent reduction in the levels of the RNA results in a decrease in both the virus and the production of viral antigen (HBsAg) by the hepatocytes, which can be measured by a drop in the HBV DNA and antigen levels in the circulating blood. Bepirovirsen has an additional property of stimulating immune responses via Toll-like receptor 8 (TLR8) which may help the immune system to achieve durable clearance of the virus from circulating blood. Hepatitis B Fact sheet. World Health Organization. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b.Updated on July 18, 2019. Accessed on November 29, 2019 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/. We are excited to continue to share new preclinical data with the Hepatitis B medical community at this important conference as we progress our therapeutic vaccine candidate, CLB-3000, toward the clinic,” said Aileen Rubio, PhD., CEO for the company. “Chronic Hepatitis B continues to be a significant global disease and we believe these data provide clear rationale for the choice antigens that comprise CLB-3000.”In the NA-naïve group (n=12), average [SD] reduction reached -1.56 [1.38] log 10 IU/ml vs. placebo 0.00 [0.11], n=6, p=0.001. Three of these patients had reductions ≥3.0 log 10 IU/mL by Day 29. Phase II trials ongoing to explore potential sequential treatment options with the aim of increasing functional cure rate The results offer an early indication that bepirovirsen might be a potential treatment, either as monotherapy or in combination with NAs, that could result in functional cure. In addition, the trial identified a potential patient sub-group more likely to benefit from treatment with bepirovirsen, helping to guide future development.
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. 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. ClearB Therapeutics was co-founded in 2017 with Professor Stephen Locarnini and the Victoria Infectious Diseases Reference Laboratory in Melbourne, Australia. ClearB is working to develop immune based therapies designed to drive functional cure of hepatitis B infection. The work is grounded in proprietary insights derived from studying rare-event infection resolution in patients who suffer from CHB. For more information, please visit https://clearbtherapeutics.com/.Phase IIb trial of bepirovirsen in sequential combination with pegylated interferon (PegIFN) treatment; 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. Extensions: Extensions can store data on your computer or in your Google Account. Learn how to uninstall an extension. 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:
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