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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. Search history & other Google activity: Searches and other activity on Google services are saved to your Google Account. Learn how to delete Google activity.
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. 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.External scientific engagement on the start of the phase IIb study of GSK4532990 in adults with nonalcoholic steatohepatitis (NASH).
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.” 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
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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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