(RTTNews) – Ionis Pharmaceuticals Inc. (IONS) announced that GSK has presented positive results from an interim analysis of the Phase 2b B-Clear clinical study of bepirovirsen (formerly IONIS-HBVRx), an investigational antisense drug for treatment of patients with hepatitis B virus. Study data demonstrated an 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 problem, affecting nearly 300 million people worldwide.
Data from the Phase 2b B-Clear study demonstrated the potential of bepivirsen to provide rapid reductions in hepatitis B surface antigen in patients not on nuke therapy and in those on stable NA therapy .
The results, along with results from previous clinical studies, supported GSK’s plan to initiate a Phase 3 clinical study evaluating bepirovirsen. Clinical phase 3 is expected to start in the first half of 2023.
In the study, 28% of patients on standard therapy, which is a stable nucleoside/nucleotide (NA) analogue, and 29% of patients not on NA therapy, experienced a virologic response (VR) with bepirovirsen 300 mg weekly , after 24 hours. weeks of treatment. Virological response is defined as serum/plasma levels of hepatitis B virus (HBV) DNA and hepatitis B surface antigen (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
End-of-treatment virological responses have been observed in patients with high or low baseline HBsAg levels who were hepatitis B e antigen (HBeAg) negative or positive and who were or were not receiving NA therapy, which indicates that bepivirsen has the potential to treat large segments of the CHB population. The sustainability of 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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