Specialist Supplements COL-Clear B Internal Cleanse Support 100 Capsules

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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. Curative treatments for hepatitis B infections with antiviral agents represent the current focus for Professor Locarnini who is also interested in intellectual property issues when applied to clinical and diagnostic virology. He is a named inventor on over 20 internationally granted patents. GSK3228836 (previously known as ‘ISIS 505358 or IONIS-HBV RX’) was discovered by and jointly developed with Ionis Pharmaceuticals. GSK3228836 is one of the ASO HBV programme assets in-licensed by GSK from Ionis Pharmaceuticals in August 2019. GSK is now fully responsible for all development, regulatory and commercialisation activities and costs. About GSK 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. Phase II trials ongoing to explore potential sequential treatment options with the aim of increasing functional cure rate

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/. 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.” Abstract Title: Impact of various expression systems on efficacy of HBsAg therapeutic vaccines to achieve clearance in a mouse model of chronic hepatitis B In addition, ClearB Therapeutics announced the acceptance of an abstract including new preclinical data for a humanized monoclonal antibody as serotherapy for the treatment of CHB for presentation at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting 2023, taking place in Boston, MA November 10 – 14, 2023.

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GSK3228836 is an investigational antisense oligonucleotide (ASO) that has been designed to specifically recognise the messenger RNA (mRNA) that the Hepatitis B virus uses to make viral antigens (disease-causing protein) in infected cells (hepatocytes) in the liver. It helps to destroy the mRNA by recruiting the liver’s own enzymes to digest it to an inactive form. The subsequent reduction in the levels of the mRNA results in a decrease in the production of viral antigen (HBsAg) by the hepatocytes, which can be measured by a drop in the antigen levels in the circulating blood.

GSK today announced that GSK’836 (GSK3228836), an investigational antisense oligonucleotide, showed marked reductions in hepatitis B surface antigen (HBsAg) and hepatitis B virus DNA compared with placebo after four weeks treatment in people with chronic hepatitis B on stable nucleoside or nucleotide analogue (NA) therapy and in patients who were NA-naïve.

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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; 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.” 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. 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. 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.Longer term durability of response will be investigated in the B-Sure trial which will follow participants for an additional 33 months and includes criteria for stopping NA therapy with the possibility to demonstrate functional cure in patients who successfully stop all medication and continue to demonstrate no serologic evidence of HBsAg or HBV DNA. There is a need for therapeutic approaches that enable not only suppression of viral replication, but resolution of chronic HBV infection. About GSK3228836