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Ionis announces positive data from GSK's Phase 2b clinical study of bepirovirsen
GSK plans to advance bepirovirsen into Phase 3 development program in 1H 2023 CARLSBAD, Calif., Nov. 8, 2022 /PRNewswire/ -- Ionis Pharmaceuticals, Inc.
About this update from Ionis Pharmaceuticals, Inc.
[{"type":"text","content":"GSK plans to advance bepirovirsen into Phase 3 development program in 1H 2023 CARLSBAD, Calif., Nov. 8, 2022 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that GSK presented positive end of study data from the Phase 2b B-Clear study of bepirovirsen (formerly IONIS-HBVRx), an investigational antisense oligonucleotide treatment for patients with chronic hepatitis B virus (CHB). The results showed that treatment with bepirovirsen resulted in sustained clearance of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA for 24 weeks after end of bepirovirsen treatment in people with CHB. The study results were presented at the American Association for the Study of Liver Diseases' (AASLD) The Liver Meeting® in Washington, DC.\n\n \n \n \n \n \n \n\n \n\"Ionis is pleased with the results of the Phase 2b B-Clear study and to see bepirovirsen advance to Phase 3 clinical studies for the potential to offer a first-in-class therapy for people with CHB, including the possibility of functional cures. With these clinically meaningful results, we believe bepirovirsen has the potential to provide significant benefit to the millions of people with this chronic disease,\" said Richard S. Geary, Ph.D., executive vice president, drug development at Ionis.\nThe results from the B-Clear Phase 2b study provide initial evidence that bepirovirsen, as monotherapy or in combination with nucleoside/nucleotide analogue (NAs), can deliver sustained reductions in HBsAg and HBV viral DNA in specific patient groups. The full results from the study are now available in The New England Journal of Medicine.\nIn treatment arm 1 of the study, 9% of patients on NA treatment and 10% of patients not on NA treatment achieved the primary outcome of HBsAg levels below the Lower Limit of Quantification (LLOQ) and HBV DNA levels below the LLOQ, respectively. This is defined as a sustained response and was observed for 24 weeks post last dose. In the study, sustained response rates were higher in subjects with low baseline HBsAg (1000 IU/mL). Patients with low baseline hepatitis B surface antigen levels responded best to treatment with bepirovirsen with 16% and 25% of patients achieving the primary outcome in treatment arm 1 of the on NA and not on NA cohort, respectively.\nCurrently, nucleoside/nucleotide analogues are the recommende...