Phase II trial of bepirovirsen in sequential combination with GSK’s chronic hepatitis B targeted immunotherapy. 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.

There is a need for therapeutic approaches that enable not only suppression of viral replication, but resolution of chronic HBV infection. About GSK3228836Using 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. 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.

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. 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.” 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. 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.” 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, 2019In 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. 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. 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.