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. 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 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. 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. 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.

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.

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As we continue to progress our therapeutic vaccine candidate, CLB-3000, toward first in human trials, we are excited to share our preclinical data with the Hepatitis B community,” said Aileen Rubio, PhD., CEO for the company. “Chronic infection with Hepatitis B (CHB) remains a significant disease, where functional cure has so far been elusive and combination therapies are likely needed. We believe that re-education of patients’ immune systems to break tolerance of their chronic HBV infections through co-administration of ClearB’s therapeutic vaccine could become an important component of such treatment regimens.”

The b-clear anti-viral sanitiser is scientifically proven to be effective at eradicating Coronavirus. UK based test Laboratories have completed the latest Gold Standard COVID-19 testing in October 2020, in which our product achieved Log4, resulting in a 99.99% virucidal kill. 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. Abstract Title : Therapeutic vaccination with CLB-3000 in a mouse model of chronic Hepatitis B induces anti-HBs responses associated with functional cure

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 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: