Ionis : GSK Presents Positive Phase 2b Data For Chronic Hepatitis B Treatment

Ionis Pharmaceuticals Inc. (IONS) announced that GSK presented positive results from an interim analysis of the Phase 2b B-Clear clinical study of bepirovirsen (formerly IONIS-HBVRx), an investigational antisense medicine for the treatment of patients with chronic hepatitis B virus. The data from the study demonstrated end-of-treatment virologic response in patients with chronic hepatitis B.

Chronic hepatitis B infection is caused by HBV and is a major global health concern, affecting nearly 300 million people worldwide.

Data from the Phase 2b B-Clear study demonstrated the potential of bepirovirsen to provide rapid reductions in hepatitis B surface antigen in both patients not on nucleoside analogue treatment and those on stable NA therapy.

The findings, together with results of previous clinical studies, supported GSK's plan to initiate a Phase 3 clinical study evaluating bepirovirsen. The Phase 3 clinical is anticipated to start in the first half of 2023.

In the study, 28% of patients on standard of care, which is stable nucleoside/nucleotide analogue (NA), and 29% of patients not on NA treatment, experienced a virologic response (VR) on 300 mg of bepirovirsen weekly, following 24 weeks of treatment. Virologic response is defined as serum/plasma levels of hepatitis B virus (HBV) DNA and hepatitis B surface antigens (HBsAg) below the lower limit of quantification. Up to 68% of patients on NA therapy and up to 65% of patients not on NA achieved HBsAg <100 IU/mL at the end of treatment.

End-of-treatment virologic responses were observed in patients with high or low baseline HBsAg levels, who were hepatitis B e-antigen (HBeAg) negative or positive, and who were receiving NA treatment or not, indicating that bepirovirsen has the potential to treat broad segments of the CHB population. Durability of the responses is being assessed.

Ionis noted that GSK will explore potential combination treatments to further reduce the global burden of chronic hepatitis B.

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