CARLSBAD, Calif. - Ionis Pharmaceuticals, Inc. (Nasdaq: 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 (CHB).

The data were presented in an oral late-breaker session at the European Association for the Study of the Liver's (EASL) International Liver Congress 2022 in London, UK. The final results from the study will be submitted for presentation at a scientific congress later this year, and for publication in a peer-reviewed journal.

'Chronic hepatitis B represents a significant healthcare challenge for which there is particular need for new treatments that provide a longer-lasting solution. 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. These findings, together with results of previous clinical studies, support GSK's plan to initiate a Phase 3 clinical study evaluating bepirovirsen,' said Sanjay Bhanot, M.D., Ph.D., senior vice president, chief medical officer and metabolic and liver franchise leader at Ionis.

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

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