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Ionis announces presentation of positive Phase 2b data for chronic hepatitis B treatment at the EASL International Liver Congress™

Published: 2022-06-25 13:05:00 ET

- Interim analysis of B-Clear clinical study of bepirovirsen demonstrated end-of-treatment virologic response (VR) in patients with chronic hepatitis B

- Phase 3 clinical study evaluating bepirovirsen as a monotherapy is anticipated to start in the first half of 2023

- GSK to explore potential combination treatments to further reduce the global burden of chronic hepatitis B

CARLSBAD, Calif., June 25, 2022 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), today 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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